Registration Dossier

Administrative data

Description of key information

To evaluate the skin and eye irritation potential of the fatty acid constituents of the substance a weight of evidence approach was adopted based on human and animal experiments conducted with octanoic, nonanoic and decanoic acids. Other fatty acids were not tested in either animals or humans.

Except for the shorter chain fatty acids (i.e. octanoic, nonanoic acid, decanoic and lauric acid), studies conducted with various other components suggest that they are not irritating or only mildly irritating to skin and eyes. Based on human and animal experiments with octanoic, nonaoic and decanoic acids, a weight of evidence approach was adopted to evaluate the skin and eye irritant properties of octanoic and decanoic acids. Mainly based on the corrosive effects observed in two studies in rabbits, octanoic acid was recently reviewed and concluded to be corrosive to skin. Decanoic acid was concluded to be irritating to skin based on overall weight of evidence from studies conducted with itself and nonanoic acid. Further, lauric acid has been notified to produce serious damage to eyes as per the CLP inventory. Overall, the weight of evidence suggests that the test substance ‘oils, vegetable, deodorizer distillates’ may present a strong skin or eye irritation potential if the corrosive/irritating constituents are present above 1-5% concentration limits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritation potential of the substance was evaluated in rats following exposure to 25% test concentration for 24 h.
GLP compliance:
not specified
Remarks:
This information is not available in the RAC opinion
Species:
rabbit
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: PEG
Controls:
not specified
Amount / concentration applied:
approximately 27-30 mg/cm2 or 25% test concentration
Duration of treatment / exposure:
24 h
Observation period:
Daily observations for 15 d
Number of animals:
5 males and 5 females
Irritation parameter:
erythema score
Time point:
24 h
Score:
>= 1 - < 2
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: developed into scaling and scabs (grade 1 to 2)
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Irritation was observed which was reversible within 15 d.
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the study conditions, the substance was considered to be irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent decanoic acid in rats according to EU method B.3 and OECD guideline 402 in compliance with GLP. In this study, 5 male and female rats were exposed to 27 -30 mg/cm2 of 25% test substance in PEG for 24 h. Erythema grade (1 -2) irritation reactions were observed in all animals after application, which developed into scaling and scabs (grade 1 to 2). The reactions were completely reversible after 14 d of observation. Hence, under the study conditions, the substance was considered to be irriating to the skin (Talvioja, 2006, cited in ECHA RAC opinon, 2013).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Qualifier:
according to guideline
Guideline:
other: OECD 427 and EU B.42 Guideline compliant LLNA
Principles of method if other than guideline:
Skin irritation of the constituent was assessed as part of the skin sensitisation testing in accordance with OECD guideline 427 and EU method B.42.
GLP compliance:
not specified
Remarks:
This information is not available in the RAC opinion
Species:
mouse
Vehicle:
other: acetone:olive oil
Controls:
not specified
Amount / concentration applied:
25 μL of 25, 50 and 70% test concentration applied per ear
Duration of treatment / exposure:
3 times in 3 consecutive d, total 9 applications
Number of animals:
4 per dose group
Irritation parameter:
other: overall irritation response
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mild skin irritation response was observed in the skin sensitisation testing
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Mild skin irritation response was observed which was not reversible within 6 d.
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the study conditions, the substance was considered to be mildly irritating to skin.
Executive summary:

A study was conducted to evaluate the skin irritation response of the constituent decanoic acid as part of a local lymph node assay conducted in mice according to EU method B.42 and OECD guideline 427 in compliance with GLP. In this study, each ear of four mice per dose group were exposed to 25 μL of 25, 50 and 70% test concentrations in acetone: olive oil (4:1) for 3 times in 3 consecutive d. Mild skin irritation response was observed only at the highest tested concentration which was not reversible within 6 d. No irritation response was observed at the lower two concentrations. Hence, under the study conditions, the substance was considered to be mildly irriating to the skin (Weber et al., 2006, cited in ECHA RAC opinon, 2013).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritation potential of the constituent was evaluated in rabbits following exposure to undiluted test concentrations for 24 h.
GLP compliance:
not specified
Remarks:
This information is not available in the RAC opinion
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.01 mL of 100% test concentration
Duration of treatment / exposure:
24 h
Number of animals:
5/group
Details on study design:
5 albino rabbits exposed to 0.1 ml 100% of the test concentration for 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
5
Max. score:
10
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritant / corrosive response data:
Severe irritation was observed and reversibility was not reported
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the study conditions, the substances were considered to be severly irritating to skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent octanoic acid and decanoic acid in rabbits. In this study, 5 albino rabbits were exposed to 0.1 mL of 100% of the test substances for 24 h. Severe irritation was observed (reporting a score of 5 out of 10), but the study did not use standard test scoring and the report included no information on reversibility. Hence, under the conditions of the study, the substances were considered to be severly irriating to the skin (Smyth et al, 1962, cited in ECHA RAC opinon, 2013).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Unknown
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritation was evaluated after application of coconut oil via 24 h single-insult occlusive patch.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
Nine animals
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.17
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Minimal irritating
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the substance was found to be minimally irritating to rabbit skin.
Executive summary:

A skin irritation study was conducted with the undiluted constituent ‘fatty acids, C8 -18 and C18 -unsatd.’ (as coconut acid) following application of 24 h semi-occlusive patches to the skin of 9 rabbits. Minimal irritation was observed after 24 h of treatment (PII = 0.17). Under the study conditions, the substance was found to be minimally irritating to rabbit skin (CIR, 1986 (1)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritation was evaluated after application of coconut oil via 24 h single-insult occlusive patch.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Vehicle:
other: corn oil
Controls:
not specified
Amount / concentration applied:
10% Fatty acids, C8-18 and C18-unsatd. in corn oil
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
Nine animals
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.13
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Minimally irritating
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the substance was found to be minimally irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent ‘fatty acids, C8 -18 and C18 -unsatd.’ (as coconut acid) in rabbits. In this study, 24 h occlusive patches containing 10% of the substance in corn oil was applied to the skin of 9 rabbits. Minimal irritation was observed after 24 h of treatment and the PII was calculated at 0.13. Under the study conditions, the substance was found to be minimally irritating to rabbit skin (CIR, 1986 (2)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: OECD guideline 402 and EU method B.3
Principles of method if other than guideline:
A primary dermal irritation study was conducted with the substance according to EU method B.4 and OECD No. 404 in rabbits and an acute dermal toxicity was conducted in accordance with EU method B.3 and OECD guideline 402 in rats. Both studies were performed in compliance with GLP.
GLP compliance:
yes
Species:
other: Rabbits and rats
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: applied undiluted in rabbits and applied through PEG solution in rats
Controls:
not specified
Amount / concentration applied:
Rabbit study: 75 mg/cm2 of the undiluted substance
Rat study: 27-30 mg/cm2 of 22% concentration in PEG
Duration of treatment / exposure:
Rabbit study: 4 h
Rat study: 24 h
Observation period:
Rabbit: 24, 48 and 72 h
Rat: Daily observation for 15 d post exposure
Number of animals:
Rabbit study: 3 males
Rat study: 5 males and 5 females
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Reversibility:
fully reversible within: 15 d
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of severe irritation
Remarks:
No scoring possible due to eschar formation, fissuring and/or brown discolouration of the skin; so considered to be severly irritating to skin of rabbits
Irritation parameter:
erythema score
Basis:
animal: 2/10 animals
Score:
>= 3 - < 4
Max. score:
4
Reversibility:
other: Erythema not reversible in 3/10 animals (grade 1 at Day 15)
Remarks on result:
other: Considered to be severely irritating to skin of rats
Irritation parameter:
other: scabs and/or scales
Basis:
other: 7/10 animals
Score:
2
Max. score:
3
Reversibility:
other: Scabs and/or scales not reversible in 6/10 animals (grade 1 at Day 15)
Remarks on result:
other: Considered to be severely irritating to skin of rats
Other effects:
In the rat study, clinical signs including hunched posture, piloerection, chromod-acryorrhoea, lethargy, uncoordinated movements and/or shallow respiration were noted among all animals between Days 1 and 5
Interpretation of results:
other: severely irritation to the skin
Conclusions:
Under the study conditions, the substance was considered to be severely irritating to skin of rabbits and rats.
Executive summary:

Two studies were conducted to evaluate the skin irritation potential of the constituent nonanoic acid according to EU method B.4 and OECD guideline 404 in rabbits and EU method B.3 and OECD guideline 402 in rats. In the rabbit study, 3 males were exposed to 75 mg/cm2 of the undiluted substance for 4 h and were scored for erythema and oedema response after 24, 48 and 72 h. The average erythema score was 4 and was reversible within 15 d. However, oedema scoring was not possible due to eschar formation, fissuring and/or brown discolouration of the skin. In the rat study, 5 males and 5 females were exposed to 27 -30 mg/cm2 of 22% test concentration in PEG solution and observed daily for 15 d for skin reactions. 2/10 animals showed erythema up to grade 3 and 4 on single days (on a scale of 1 -4) and 7/10 animals had scabs and/or scales up to grade 2 on single days (on a scale 1 -3). Hence, under the study conditions, the substance was considered to be severely irriating to the skin of rabbits and rats (ECHA RAC opinon, 2013 (1)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Principles of method if other than guideline:
A study was conducted to evaluate the dermal irritation of the constituent as part of a guinea pig maximisation test conducted according to EU method B.6, OECD guideline 406 in compliance with GLP.
GLP compliance:
yes
Species:
guinea pig
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: corn oil
Controls:
not specified
Amount / concentration applied:
The following test concentrations in corn oil was applied in the pre-test and main test:
Pre test:
- 0.75 mg/cm2 of 1%
- 1.5 mg/cm2 of 2%
- 3.75 mg/cm2 of 5%
- 7.5 mg/cm2 of 10%
- 15 mg/cm2 of 20%
- 37.5 mg/cm2 of 50%
- 75 mg/cm2 of 100%
Main test: 0.15 mg/cm2 of 1%
Duration of treatment / exposure:
24 h
Number of animals:
Pre test:
- 1 animal each at 1, 2 and 5% test concentrations
- 2 animals each at 10, 20, 50 and 100% test concentrations
Main test: 15 animals at 1% concentration
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
>= 0 - <= 4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
>= 0 - <= 4
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
other: Not measured and no more details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
other: Not measured and no more details given
Interpretation of results:
other: Severely irritating to skin
Conclusions:
Under the study conditions, the substance was considered to be severely irritating to skin at ≥50% test concentrations.
Executive summary:

The skin irritation potential of the constituent nonanoic acid was determined in a Guinea pig maximisation test (GPMT) conducted according to EU method B.6 and OECD guideline 406, in compliance with GLP. The induction and challenge concentrations for the main test were determined by evaluating test concentrations ranging from 1 -100% using 1 -2 animals per dose group. The test substance was found to be severely irritating at ≥50%, mildly irritating at 2-10% and not irritating to skin at ≤1%. As a result, the main test was conducted with 15 animals at 1% test concentration. Under the study conditions, the substances were considered to be severely irriating to the skin at ≥50% test concentrations (ECHA RAC opinon, 2013 (2)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Undiluted palm oil was evaluated in a single-insult occlusive patch test on rabbits. Scoring of the effects was done 2 h and 24 h post application.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
occlusive
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): Undiluted
Observation period:
2 and 24 h post application
Number of animals:
Nine
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.22
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritant / corrosive response data:
At 2 h post application, five rabbits revealed an irritation score of 0 and the remaining four displayed a score of 0.5. At 24 h post application, one rabbit had a score of 0.5 and the remaining rabbits had a score of 0.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the substance was found to be practically non-irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C16 -18 and C18 -unsatd.’ (as palm oil) in rabbits. In this study, the undiluted substance was applied as a single-insult occlusive patch on rabbit skin. Scoring of the effects was done 2 h and 24 h post-application. Slight effects were observed on 4 rabbits and 1 rabbit after 2 and 24 h post-treatment, respectively. The PDII was found to be 0.22. Under the test conditions, the substance was found to be practically non-irritating to rabbit skin (CIR, 2000).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
A primary dermal irritation study was conducted in rabbits to evaluate skin irritation potential of a formulation containing fully hydrogenated cottonseed oil.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
occlusive
Vehicle:
other: Formulation base
Controls:
not specified
Amount / concentration applied:
8.97% fully hydrogenated cottonseed oil
Duration of treatment / exposure:
24 h
Observation period:
Erythema and edema observed at 2 h and 24 h after exposure
Number of animals:
Nine
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: mean of 2 and 24 h
Score:
0.06
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritant / corrosive response data:
Not irritating
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the constituent tested at 8.97% was found to be non-irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C16-18’ (as fully hydrogenated cottonseed oil) in rabbits. In this study, a single occlusive patch containing 8.97% of the substance was applied to nine rabbits. Sites were evaluated for erythema and edema at 2 and 24 h after exposure. The maximum possible irritation index (PII) score was 8. The PII of the formulation was found to be 0.06. Under the test conditions, the constituent tested at 8.97% was found to be non-irritating to rabbit skin (CIR, 2001 (1)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
A primary dermal irritation study was conducted in rabbits to evaluate skin irritation potential of a formulation containing fully hydrogenated cottonseed oil.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
occlusive
Controls:
not specified
Amount / concentration applied:
8% fully hydrogenated cottonseed oil
Duration of treatment / exposure:
24 h
Observation period:
Erythema and edema observed at 2 h and 24 h after exposure
Number of animals:
Nine
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: mean of 2 and 24 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritant / corrosive response data:
Not irritating

None

Interpretation of results:
GHS criteria not met
Conclusions:
Under the est conditions, the constituent tested at 8% was found to be non-irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C16-18’ (as fully hydrogenated cottonseed oil) in rabbits. In this study, a single occlusive patch containing 8% ‘glycerides, C16 -18’ (as fully hydrogenated cottonseed oil) was applied to nine rabbits. Sites were evaluated for erythema and edema at 2 h and 24 h after exposure. The maximum possible irritation index (PII) score was 8. The PII of the formulation was found to be 0. Under the test conditions, the constituent tested at 8% was found to be non-irritating to rabbit skin (CIR, 2001 (2)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
A primary dermal irritation study was conducted in rabbits to evaluate skin irritation potential of a formulation containing fully hydrogenated cottonseed oil.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
occlusive
Controls:
not specified
Amount / concentration applied:
3.4% fully hydrogenated cottonseed oil
Duration of treatment / exposure:
24 h
Observation period:
Erythema and edema observed at 2 h and 24 h after exposure
Number of animals:
Nine
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: mean of 2 h and 24 h
Score:
0.22
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritant / corrosive response data:
Not irritating
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the constituent tested at 3.4% was found to be non-irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C16-18.’ (as fully hydrogenated cottonseed oil) in rabbits. In this study, a single occlusive patch containing 3.4% of the substance was applied to nine rabbits. Sites were evaluated for erythema and edema at 2 h and 24 h after exposure. The maximum possible irritation index (PII) score was 8. The PII of the formulation was found to be 0.22. Under the test conditions, the constituent tested at 3.4% was found to be non-irritating to rabbit skin (CIR, 2001 (3)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritation was evaluated after application of coconut oil via 24 h single-insult occlusive patch.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
9 animals
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Not irritating
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the constituent was found to be non-irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the irritation potential of the constituent ‘glycerides, C8-18 and C18-unsatd.’ (as coconut oil) in rabbits. In this study, the undiluted constituent was applied to the skin of 9 rabbits by means of a 24 h single-insult occlusive patch. No irritation was observed after 24 h of treatment (PII = 0). Under the test conditions, the constituent was found to be non-irritating to rabbit skin (CIR, 1986).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritation was evaluated after application of fully hydrogenated coconut oil via 24 h single-insult occlusive patch.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
9 animals
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.11
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Minimal irritation
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the substance was found to be minimally irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil) in rabbits. In this study, the undiluted substance was applied to the skin of 9 rabbits by means of a 24 h single-insult occlusive patch. Minimal irritation was observed after 24 h of treatment (PII = 0.11). Under the test conditions, the substance was found to be minimally irritating to rabbit skin (CIR, 1986 (1)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dermal irritation was evaluated after application of fully hydrogenated coconut oil via 24 h single-insult occlusive patch.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
9 animals
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Not irritating
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the substance was found to be non-irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C8 -18 and C18 -unsatd.’ (as fully hydrogenated coconut oil) in rabbits. In this study, the undiluted substance was applied to the skin of 9 rabbits by means of a 24 h single-insult occlusive patch. No irritation was observed after 24 h of treatment (PII = 0.0). Under the test conditions, the substance was found to be non-irritating to rabbit skin (CIR, 1986 (2)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method followed unknown
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
0, 24, 48 and 72 h
Irritation parameter:
other: overall irritation response
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Slightly irritating (slight effects with 2-3 sites showing a slight to moderate response 24 and 72 h after treatment)
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the constituent was found to be slightly irritating to rabbit skin.
Executive summary:

A study was conducted to evaluate the skin irritation potential of the constituent ‘glycerides, C8 -18 and C18 -unsatd.’ (as palm kernel oil) in rabbits. In this study, 0.5 mL of the undiluted substance was applied to the clipped dorsum of rabbits for 4 h under semi-occlusive conditions. Scoring of the effects was done after 0, 24, 48 and 72 h. Slight effects were observed with 2 -3 sites showing a slight to moderate response 24 and 72 h after treatment. Under test conditions, the constituent was found to be slightly irritating to rabbit skin (IUCLID DS, 2000).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.5 mL of the undiluted constituent squalene was applied to the abraded and intact skin of three rabbits for 24 h in a skin irritation study conducted according to the Draize procedure.
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
not specified
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL of undiluted squalene
Duration of treatment / exposure:
24 h
Number of animals:
Three
Irritation parameter:
other: Not reported
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritant / corrosive response data:
The substance did not produce any signs of irritation.
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance did not produce any signs of irritation.
Executive summary:

A study was conducted in rabbits to evaluate the skin irritation potential of the undiluted constituent squalene. According to the Draize method, the undiluted substance (0.5 mL) was applied to the abraded and intact skin of three rabbits for a period of 24 h. Under the test conditions, the substance did not produce any signs of irritation (CIR, 1982).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method followed unknown, data from SCF opinion
GLP compliance:
not specified
Species:
rabbit
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Irritation parameter:
other:
Remarks:
parameter not documented
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritant / corrosive response data:
Not irritating
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was found to be non-irritating to rabbit skin.
Executive summary:

Under the test conditions, tall oil-derived 'β-Sitosterol' was found to be non-irritating to rabbit skin (SCF, 2003).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The dermal irritation potential of 1.0% tocopherol in paraffin was investigated using male Japanese white rabbits. The primary irritation index was calculated according to the Draize scoring system.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Japanese white
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
other: paraffin
Controls:
not specified
Amount / concentration applied:
1.0% tocopherol in paraffin
Duration of treatment / exposure:
24 h
Observation period:
24 h and 72 h after application of tocopherol
Number of animals:
Eight
Details on study design:
- The backs of the eight rabbits were clipped free of hair 1 d prior to dosing, and the skin on the backs of four of the animals was abraded.
- 0.3 mL of the constituent was applied to the back of each animal under an occlusive patch (using “patch-test plaster”) for 24 h.
- The test sites were scored for irritation 24 and 72 h after application of the constituent.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0.13
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Interpretation of results:
study cannot be used for classification
Conclusions:
Under test conditions, 1% of the substance was assessed to be a weak primary skin irritant.
Executive summary:

The dermal irritation potential of 1.0% of the constituent tocopherol in paraffin was investigated using male Japanese white rabbits. The backs of the eight rabbits were clipped free of hair 1 d prior to dosing, and the skin on the backs of four animals was abraded. 0.3 mL of the substance was applied to the back of each animal under an occlusive patch (using “patch-test plaster”) for 24 h. The test sites were scored for irritation 24 and 72 h after application of the substance. The primary irritation index (PII), calculated according to the Draize scoring system was 0.13/8.0. Under test conditions, 1% of the substance was assessed to be a weak primary skin irritant (Fiume, 2002 (1)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The irritation potential of 1.0% tocopherol in paraffin was determined using 55 human subjects.
GLP compliance:
not specified
Species:
human
Strain:
other: not applicable
Type of coverage:
not specified
Preparation of test site:
other: human patch test plaster
Vehicle:
other: paraffin
Controls:
not required
Amount / concentration applied:
1% tocopherol
Duration of treatment / exposure:
24 h
Observation period:
After 24 h of application
Number of animals:
55 human volunteers
Irritation parameter:
other: positive rate
Basis:
other: percent rate of the number of subjects with a positive reaction above the score 2 (1+ for distinct erythema)
Time point:
24 h
Score:
0
Max. score:
5
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details given
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was not a primary skin irritant at 1% test concentration.
Executive summary:

The irritation potential of 1.0% tocopherol in paraffin was determined using 55 subjects (number per sex not specified). The test substance, 0.05 mL, was placed on human patch test plaster and applied to the intact surface of the forearm for 24 h. The test sites were scored on a scale of 0 (-) to 5 (4+) upon removal of the plaster. The positive rate was defined as the percent rate of the number of subjects with a positive reactive above the score 2 (1 +) (distinct erythema). The positive rate was 0/55 (0%). Under the test conditions, 1% test substance was not considered to be a primary skin irritant (Fiume, 2002 (2)).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The cumulative skin irritation potential of the constituent 1.0% tocopherol in paraffin was investigated using three male Hartley guinea pigs.
GLP compliance:
not specified
Species:
guinea pig
Strain:
Hartley
Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
other: paraffin
Controls:
not specified
Amount / concentration applied:
0.05 mL of 1% tocopherol in paraffin
Duration of treatment / exposure:
3 d
Observation period:
24 h after each application
Number of animals:
Three rabbits
Details on study design:
0.05 mL of the substance was applied to a shaved 2 x 2 cm2 area on the flank of each animal once daily for 3 consecutive days. The test sites were scored 24 h after each application.
Irritation parameter:
other: Cumulative irritation index
Basis:
mean
Time point:
24 h
Score:
0.44
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details given
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, 1% of the substance was assessed as a weak skin irritant.
Executive summary:

The cumulative skin irritation potential of 1.0% of the constituent tocopherol in paraffin was investigated using three male Hartley guinea pigs. In this study, 0.05 mL of 1% of the substance was applied to a shaved (2 x 2 cm2 area) flanks of each animal once daily for 3 consecutive days. The test sites were scored 24 h after each application. The cumulative irritation index was 0.44/4.0. Under the test conditions, 1% of the substance was assessed as a weak skin irritant (Fiume, 2002 (3)).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The eye irritation potential of octanoic and nonanoic acid were evaluated on the basis of two non-GLP studies conducted in rabbits (Smyth et al, 1962 and Briggs et al, 1976 cited in the ECHA RAC opinion).
GLP compliance:
not specified
Remarks:
This information is not available in the RAC opinion
Species:
rabbit
Vehicle:
not specified
Number of animals or in vitro replicates:
Smyth et al., 1962 study: 5 rabbits per group
Briggs et al., 1976 study: no information available
Irritation parameter:
other: Corneal effects
Basis:
mean
Time point:
other: not specified
Score:
ca. 9
Max. score:
10
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the conditions of the studies, the substances were considered to cause severe damage to the eyes.
Executive summary:

Two non-GLP studies were conducted to evaluate the eye irritation potential of the constituent fatty acids octanoic and decanoic acids in rabbits. One of the study (by Smyth et al, 1962 cited in ECHA RAC, 2013) conducted in 5 rabbits per group resulted in grade 9 corneal effects, indicating risk for severe damage to the eye for both octanoic and decanoic acid. No information on the concentration or on the reversibility was provided. The other study (by Briggs et al, 1976 cited in ECHA RAC, 2013) revealed corneal opacity, with no reversibility over up to 72 h. No information on the number of rabbits or on the concentrations of the substances was provided and no scoring was applied. Overall, under the conditions of the studies, both the substances were considered to cause severe damage to the eyes (ECHA, RAC, 2013).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Remarks:
This information is not available in the RAC opinion
Species:
rabbit
Vehicle:
not specified
Amount / concentration applied:
0.1 mL of 70% concentration
Duration of treatment / exposure:
24 h
Observation period (in vivo):
over 72 h
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
0.1 mL of 70% octanoic acid was applied for 24 h to 3 rabbits. The animals were observed over 72 h and at 6, 9, and 11 d after dosing.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 9 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
1.67
Reversibility:
fully reversible within: 9 d
Irritation parameter:
other: discharge
Basis:
mean
Time point:
72 h
Score:
2
Reversibility:
fully reversible within: 9 d
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 9 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
ca. 0.67
Reversibility:
fully reversible within: 9 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Remarks on result:
other: No details provided
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Conjunctival redness, chemosis and discharge were observed in all animals, with average score of 1, 1.67 and 2. In two animals, lesions of the iris (average score 1 in both animals) and the cornea (average 72 h scores 1.33 and 0.67, respectively) were observed. At the end of the prolonged observation period of 9 d no corneal, iris or other lesions were seen in any of the three animals.
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the study conditions, the substance was considered to be irritating to the eyes.
Executive summary:

An OECD Guideline compliant study was conducted to evaluate the eye irritation potential of octanoic acid in rabbits. In this study, 0.1 mL of 70% test substance concentration was applied for 24 h to 3 rabbits. The animals were observed over 72 h and at 6, 9, and 11 d after dosing. Conjunctival redness, chemosis and discharge were observed in all animals, with average score of 1, 1.67 and 2. In two animals, lesions of the iris (average score 1 in both animals) and the cornea (average 72 h scores 1.33 and 0.67, respectively) were observed. At the end of the prolonged observation period of 9 d no corneal, iris or other lesions were seen in any of the three animals. Under the study conditions, the substance was considered to be irritating to the eyes (ECHA RAC, 2013).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of coconut oil was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
Single administration without eye rinse
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six animals
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: Until reversal of effects
Score:
9
Max. score:
110
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Mild irritant
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the conditions of the study, the substance was found to be mildly irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the eye irritation potential of the constituent ‘fatty acids, C8 -18 and C18 -unsatd.’ (as coconut acid). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Mild irritation (score: 9/110) was observed. The eyes appeared normal by the fourth day. Under the conditions of the study, the substance was found to be mildly irritating to rabbit eyes (CIR, 1986 (1)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of coconut acid was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
Single administration without eye rinse
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six animals
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: Until reversal of effects
Score:
8
Max. score:
110
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Mild irritant
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the conditions of the study, the substance was found to be mildly irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the ocular irritation potential of the constituent ‘fatty acids, C8 -18 and C18 -unsatd.’ (as coconut acid). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Mild irritation (score: 8/110) was observed. The eyes appeared normal by the fourth day. Under the conditions of the study, the substance was found to be mildly irritating to rabbit eyes (CIR, 1986 (2)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
Eye irritation potential of the constituent coconut acid was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Amount / concentration applied:
Undiluted
Duration of treatment / exposure:
Single administration without eye rinse
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six animals
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: until reversal of effects
Score:
1
Max. score:
110
Reversibility:
fully reversible within: 3 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Minimal irritant
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the study conditions, the substance was found to be minimally irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the ocular irritation potential of the constituent ‘fatty acids, C8 -18 and C18 -unsatd.’ (as coconut acid). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Mild irritation (score: 1/110) was observed. The eyes appeared normal by the third day. Under the study conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986 (3)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of castor oil was evaluated in rabbits according to the official French methods
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Details on study design:
Study was performed according to the official French methods without ocular rinsing


Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
No corneal involvement was found. However, slight congestion of the iris and conjunctiva was observed.
Interpretation of results:
study cannot be used for classification
Conclusions:
Under test conditions, the test substance was found to be slightly irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the irritation potential of the constituents ‘glycerides, C16 and C18 -unsatd. and C18-unsatd. hydroxy’ (as castor oil) on the rabbit eyes was assessed according to the official French methods. Following the instillation of undiluted test substance (no ocular rinsing), no corneal involvement was found. However, slight congestion of the iris and conjunctiva was observed. Under test conditions, the substance was found to be slightly irritating to rabbit eyes (CIR, 2007 (1)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
Eye irritation potential of castor oil was evaluated in rabbits after single ocular administration
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
Reactions were scored 18 to 24 h after instillation
Number of animals or in vitro replicates:
Five
Details on study design:
SCORING SYSTEM: The individual numerical scores for each eye were added together and then divided by the number of eyes. An ocular injury score of 5.0 represents severe injury, and corresponds to necrosis (covering approximately three-fourths of the corneal surface) that is visible only after staining or a more severe necrosis covering a smaller area.
Irritation parameter:
other: ocular injury score
Basis:
mean
Time point:
other: 18-24 h
Score:
1
Max. score:
20
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
An injury grade of 1 (maximum score possible = 20) was reported for castor oil
Interpretation of results:
study cannot be used for classification
Conclusions:
Under test conditions, the substance was found to be slightly irritating to rabbit eyes.
Executive summary:

A study was conducted in rabbits to evaluate the eye irritation potnetial of the constituent ‘glycerides, C16 and C18 -unsatd. and C18 -unsatd. hydroxy’ (as castor oil). 0.5 mL of the undiluted substance was instilled into the eyes of five rabbits. The reactions were scored 18 to 24 h later. An injury grade of 1 (maximum score possible = 20) was reported for castor oil. Under the test conditions, the substance was found to be slightly irritating to rabbit eyes (CIR, 2007).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
In an ocular irritation test, 2% of the constituent palm oil was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Ocular irritation reactions were scored using Draize scale (0 -110).
GLP compliance:
not specified
Species:
rabbit
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 2.0%


Duration of treatment / exposure:
Single instillation without eye wash
Observation period (in vivo):
up to 2 d
Number of animals or in vitro replicates:
Six
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
110
Reversibility:
fully reversible within: 2 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, 2% of the substance was found to be minimally irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the ocular irritation potential of 2% of the constituent 'glycerides, C16 -18 and C18 -unsatd.’ (as palm oil). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Ocular irritation reactions were scored using Draize scale (0 -110). Total ocular irritation score was 1 after 24 h of instillation. The eyes appeared normal by the second day. Under the test conditions, 2% of thesubstance was found to be minimally irritating to rabbit eyes (CIR, 2000).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
In an ocular irritation test, the undiluted constituent palm oil was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Ocular irritation reactions were scored using Draize scale (0 -110).
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): Undiluted


Duration of treatment / exposure:
Single instillation without eye wash
Observation period (in vivo):
up to 3 d
Number of animals or in vitro replicates:
Six
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
ca. 3
Max. score:
110
Reversibility:
fully reversible within: 3 d
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
ca. 1
Max. score:
110
Reversibility:
fully reversible within: 3 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the undiluted substance was found to be minimally irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the ocular irritation potential of the undiluted constituent ‘glycerides, C16 -18 and C18 -unsatd.’ (as palm oil). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Ocular irritation reactions were scored using the Draize scale (0 -110). Total ocular irritation score was 3 on Day 1 post instillation and 1 on Day 2 post instillation. The eyes appeared normal by the third day. Under the test conditions, the undiluted substance was found to be minimally irritating to rabbit eyes (CTFA, 1978).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
A primary ocular irritation study was conducted in rabbits to evaluate eye irritation potential of a formulation containing fully hydrogenated cottonseed oil.
GLP compliance:
not specified
Species:
rabbit
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
3.4, 8, 10 or 12.3% fully hydrogenated cottonseed oil
Observation period (in vivo):
Cornea, iris, and conjunctiva were evaluated at Days 1, 2, 3, 4, and 7 after instillation
Number of animals or in vitro replicates:
Six
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details provided
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Mildly irritating
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, 3.4 - 12.3% of the substance was found to be mildly irritating to rabbit eye.
Executive summary:

A study was conducted to determine the eye irritation potential of 3.4 -12.3 of the constituent 'glycerides, C16-18' (as fully hydrogenated cottonseed oil) in six rabbits. Cornea, iris, and conjunctiva were evaluated at Days 1, 2, 3, 4, and 7 after instillation. Under the test conditions, the substance was found to be mildly irritating to rabbit eye (CIR, 2001).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of the constituent coconut oil was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Duration of treatment / exposure:
Single administration without eye wash
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: Until reversal of effects
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 3 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Minimal irritation
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was found to be minimally irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the eye irritation potential of the constituent 'glycerides, C8 -18 and C18 -unsatd.’ (as coconut oil) according to an unspecified method. The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 2/110) was observed. The eyes appeared normal by the third day. Hence, under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of the constituent coconut oil was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Duration of treatment / exposure:
Single administration without eye wash
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: Until reversal of effects
Score:
1
Max. score:
110
Reversibility:
fully reversible within: 2 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Minimal irritation
Conclusions:
Under the test conditions, the substance was found to be minimally irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the eye irritation potential of the constituent ‘glycerides, C8 -18 and C18 -unsatd.’ (as coconut oil) according to an unspecified method. The undiluted substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 1/110) was observed. The eyes appeared normal by the second day. Under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986 (2)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of fully hydrogenated coconut oil was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Duration of treatment / exposure:
Single administration without eye wash
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: Until reversal of effects
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 3 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Minimal irritation
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was found to be minimally irritating to rabbit eyes.
Executive summary:

In an ocular irritation test, the constituent ‘glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil) was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 2/110) was observed. The eyes appeared normal by the third day. Under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986 (1)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of fully hydrogenated coconut oil was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Duration of treatment / exposure:
Single administration without eye wash
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: Until reversal of effects
Score:
ca. 6
Max. score:
110
Reversibility:
fully reversible within: 4 d
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Mild irritation
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was found to be mildly irritating to rabbit eyes.
Executive summary:

In an ocular irritation test, ‘glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil) was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Mild irritation (score: 6/110) was observed. The eyes appeared normal by the fourth day. Under the test conditions, the test substance was found to be mildly irritating to rabbit eyes (CIR, 1986 (2)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of fully hydrogenated coconut oil was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Duration of treatment / exposure:
Single administration without eye wash
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: until reversal of effects
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 3 d
Remarks on result:
other: Minimal irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Minimal irritation
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was found to be minimally irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the ocular irritation potential of tye constituent ‘glycerides, C8 -18 and C18 -unsatd.’ (as fully hydrogenated coconut oil). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 2/110) was observed. The eyes appeared normal by the third day. Under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986 (3)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
Eye irritation potential of fully hydrogenated coconut oil was determined in rabbits after single ocular administration.
GLP compliance:
not specified
Species:
rabbit
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye acted as control
Duration of treatment / exposure:
Single administration without eye wash
Observation period (in vivo):
Until reversal of effects
Number of animals or in vitro replicates:
Six
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: until reversal of effects
Score:
1
Max. score:
110
Reversibility:
fully reversible within: 2 d
Remarks on result:
other: Minimal irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritant / corrosive response data:
Minimal irritation
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was found to be minimally irritating to rabbit eyes.
Executive summary:

A study was conducted to determine the ocular irritation potential of the constituent ‘glycerides, C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil). The substance was instilled into eyes of six rabbits in a single dose without subsequent eye wash. Minimal irritation (score: 1/110) was observed. The eyes appeared normal by the second day. Under the test conditions, the substance was found to be minimally irritating to rabbit eyes (CIR, 1986 (4)).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation potential of the undiluted constituent squalene was evaluated upon instillation into eyes of rabbits according to the Draize procedure. The study details were not reported in the CIR report, but the details documented have been taken from standard Draize test method.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Undiluted squalene
Duration of treatment / exposure:
72 h aaccording to the standard Draize test method
Observation period (in vivo):
1, 4, 24, 48, and 72 h after exposure according to the standard Draize test method
Number of animals or in vitro replicates:
Minimum three according to the standard Draize test method
Irritation parameter:
maximum mean total score (MMTS)
Remarks:
Draize eye irritation method
Basis:
mean
Time point:
other: 72 h
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: No irritation was observed, but details on score unavailable in the CIR
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the undiluted substance was found to be non-irritating to the eyes of rabbits.
Executive summary:

A study was conducted to evaluate the eye irritation potential of the undiluted constituent squalene upon instillation into eyes of rabbits. The undiluted substance (0.1 mL) was instilled into the eyes of rabbits and scored following Draize procedure. The eyes were not rinsed after instillation. Under the test conditions, the undiluted substance was found to be non-irritating to the eyes of rabbits (CIR, 1982).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The occular irritation potential of 0.1 mL dl-alpha-tocopherol was investigated using nine New Zealand white rabbits.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1 mL dl-alpha-tocopherol (conc. not reported)
Duration of treatment / exposure:
7 d
Observation period (in vivo):
1, 2, 3, and 7 d after instillation.
Number of animals or in vitro replicates:
Nine
Details on study design:
- 0.1 mL dl-alpha-tocopherol was instilled into the conjunctival sac of one eye of each of nine New Zealand white rabbits;
- The eyes of three of the animals were rinsed 2 min after instillation, while the eyes of the remaining animals were not rinsed.
- The eyes were evaluated 1, 2, 3, and 7 d after instillation.
Irritation parameter:
other: overall irritation response
Basis:
other: not specified
Time point:
other: not specified
Remarks on result:
other: very slight conjunctival redness and chemosis
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: No details provided
Irritant / corrosive response data:
- Very slight conjunctival redness and chemosis was observed in both rinsed and non-rinsed eyes for 7 d.
- The eyes of two animals which were not rinsed had well-defined conjunctival redness 2 d after instillation.
- Also, there was positive retention of 2% sodium fluorescein stain 1 d after instillation; retention was observed occasionally at 7 d.
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the substance was assessed to produce very slight irritation when instilled into eyes of rabbits.
Executive summary:

A study was conducted to determine the ocular irritation potential of the constituent tocopherol in New Zealand white rabbits. A volume of 0.1 mL of the test substance was instilled into the conjunctival sac of one eye of each of nine New Zealand white rabbits; the eyes of three of the animals were rinsed 2 min after instillation, while the eyes of the remaining animals were not rinsed. The eyes were evaluated 1, 2, 3, and 7 d after instillation. For 7 d, very slight conjunctival redness and chemosis was observed in both rinsed and non-rinsed eyes. The eyes of two animals which were not rinsed had well-defined conjunctival redness 2 d after instillation. Also, there was positive retention of 2% sodium fluorescein stain 1 d after instillation; retention was for 7 d. Under the test conditions, the substance was assessed to produce very slight irritation when instilled into rabbit eyes (CIR, 2002).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
The occular irritation potential of neat tocopherol was investigated using three male Japanese white rabbits.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Japanese white
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of undiluted tocopherol
Duration of treatment / exposure:
7 d
Observation period (in vivo):
1 and 4 h and 1, 2, 3, 6, and 7 d after instillation
Number of animals or in vitro replicates:
Three rabbits
Details on study design:
0.1 mL of the undiluted substance was instilled into the conjunctival sac of one eye of each animal, and the eye was not rinsed. The eyes were evaluated at 1 and 4 h and 1, 2, 3, 6, and 7 d after instillation according to the Draize scoring system.
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 h after dosing
Score:
6
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: Calculated according to the Draize scoring system.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No details provided
Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, the undiluted substance was assessed to be a minimal eye irritant.
Executive summary:

The occular irritation potential of the undiluted constituent tocopherol was investigated using three male Japanese white rabbits. 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of one eye of each animal, and the eye was not rinsed. The eyes were evaluated at 1 and 4 h and 1, 2, 3, 6, and 7 d after instillation according to the Draize scoring system. The maximum score was observed 1 h after dosing; the average total score at this time was 6.0/110. Hence, under the test conditions, the undiluted substance was assessed to be a minimal eye irritant (CIR, 2002).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

No study has been conducted on the skin irritation potential of ‘oils, vegetable, deodorizer distillates’ in animals or humans. However, data is available for its constituents (see above tables):

Glycerides:

·        Glycerides with chain lengths ranging between C8-18 or C16-18, including C18-unsatd., were tested in rabbit and found to be not or only slightly irritating to skin (CIR, 1986, 2000 and 2001a; IUCLID, 2000b).

·        According to the Biotech Index (1970b), glycerides with chain lengths ranging from C8-18, including C18-unsatd. are not irritating to human skin after an exposure of 4 h.

Fatty acids:

·        Tests in animals show that the skin irritation potential of the constituent fatty acids taken individually decreases with increasing chain length, such that the very short chain acids are irritating or corrosive, the medium chain length C10 is irritant and C12 is minimally irritant (Opdyke, 1981; CIR, 1986; HERA, 2002). The longer chain lengths, C14 and above, are not irritant (CIR, 1986).

·        Studies in humans on the relative irritancy of individual fatty acids under occlusive patch conditions have revealed that the even-numbered chain saturated fatty acids of C8 through C12 lengths are the most irritating. With 0.5 M fatty acids, there was an erythematous response by the tenth day in most males (total of 10 subjects) at the sites of application of C8 -C12 fatty acids. There was a negligible response to the other fatty acids (C14 through C18). By the eighth day of application of the 1.0 M saturated fatty acids, there was an erythematous response in all subjects at the sites of application of C8 -C12 fatty acids. There was a negligible response to fatty acids of C14 through C18 (HERA, 2002). No information could be found on fatty acid mixes representative for ‘oils, vegetable, deodorizer distillates’.

·        As per a recently published ECHA Committee for Risk Assessment (RAC) opinion, the three organic acids (i.e. octanoic acid, nonanoic acid and decanoic acid) when tested in rabbits, guinea pigs and mice induced mild to severe skin irritation. Where determined, there was reversibility within 15 d in animal studies, except in two tests using 100% octanoic acid, which showed necrosis. Irritation was also seen in most of the volunteers exposed up to 48 h at concentrations of 20% or higher in a human patch test. For ethical reasons most human studies were not continued when irritation was observed. Therefore, the RAC concluded octanoic acid to be corrosive to skin based on the corrosion effects observed in two studies in rabbits. However, in light of insufficient evidence to clearly indicate skin corrosion and considering the similar pKa values of decanoic acid and nonanoic acid (which showed borderline responses for skin corrosion), the RAC concluded decanoic acid to be only irritating to skin (ECHA RAC, 2013a,b).

UMs:

·        In various review reports, the constituents tocopherols, sterols, sterol esters and squalene are reported to be minimally or not irritating to skin (Fiume, 2002; SCF, 2003; CIR, 1982).

·        When applied at 1% in paraffin in an HRIPT test, tocopherol was not a primary skin irritant (Fiume, 2002). No information was found on sterols, sterol esters and squalene. Squalene is nevertheless only midly irritating to eyes at the maximum, therefore it is unlikely to be irritating to skin.

Overall, the weight of evidence suggests that ‘oils, vegetable, deodorizer distillates’ may present skin corrosion to irritation potential depending upon the concentrations of the hazard triggering free fatty acid components.

Eye:

There is no direct study data on the eye irritation potential of the test substance ‘oils, vegetable, deodorizer distillates’ in animals or humans. However, animal data is available for its constituents (see also the table above):

Glycerides:

·        Glycerides with chain lengths ranging between C8 -18 or C16 -18, including C18 -unsatd. and C18 -unsatd. hydroxy were tested in rabbits and found to be minimally to mildly irritating to eyes (CIR, 1986, 2000, 2001a and 2007).

Fatty acids:

·        As with skin irritation, tests in animals have shown that the eye irritation potential of fatty acids taken individually decreases with increasing chain length, such that chain lengths C8, C10 and C12 are irritant and the longer chain lengths, C14 and above are not (CIR, 1987; HERA, 2002).

·        As per the recently published ECHA Committee for Risk Assessment (RAC) opinion, the available information on the three organic acids (i.e. octanoic acid, nonanoic acid and decanoic acid) was inconsistent and did not allow a clear differentiation between irreversible and reversible effects on the eyes. The poorly described Smyth et al.,1962 study indicated that there were irreversible effects resulting from treatment with octanoic and decanoic acid, which was not supported by the study of Briggs et al., 1976 and the more recent study by Leoni and Riedel, 2011 on octanoic acid, from which a classification of Eye Irrit. 2 - H313 at 70% could be derived. Further, the study by Briggs et al., 1976 did not provide sufficient information to evaluate the irritating potencies of octanoic and decanoic acids. Hence, based on the available information, the RAC concluded octanoic and decanoic acid would be irritating to the eyes (RAC, 2013a,b).

UMs:

·        In various reviews, tocopherols and squalene are indicated to be not irritating or minimally irritating to eyes (Fiume, 2002; CIR, 1982). No information could be found on sterols and sterol esters.

Overall, the above weight of evidence suggests that the test substance ‘oils, vegetable, deodoriser distillates may present an eye irritation potential depending upon the concentrations of the hazard triggering free fatty acid components.

No human information could be found on the eye irritation profile of the test substance. As part of good operating practices, safety goggles are recommended to be worn when handling this substance, especially when in liquid form. No eye exposure should therefore occur under normal and foreseeable use conditions.

Respiratory:

Exposure via the inhalation route is not expected to be significant given the low vapour pressure of the substance. Further, the likely inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due to implementation of strict risk management measures in workplace (see sections 9 and 10 of the CSR).

Justification for classification or non-classification

The eye and skin irritation potential of the test substance ‘oils, vegetable, deodorizer distillates’ can be deduced based on information on the individual constituents.

Except for the shorter chain fatty acids (i.e. octanoic, nonanoic, decanoic and lauric acid), studies conducted with various other components suggest that they are not irritating or mildly irritating to skin and eyes and do not warrant any classification according to CLP Regulation. However, octanoic and decanoic acids both have been recently classified for skin and eye irritation endpoints according to the 7th adaptation to technical progress (ATP) of the Classification, Labelling and Packaging (CLP) Regulation. While octatonic acid has been classified as Skin Corr. 1 C; H314 (based on the corrosive effects observed in two studies in rabbits), decanoic acid has been classified as Skin Irrit. 2; H315 (based on a weight of evidence from studies conducted with the substance itself and nonanoic acid). Also, for lauric acid a revised classification as Eye Damage 1; H318 (with a specific concentration limit of ≥73.6%) has been proposed which although not harmonized, has been notified by majority of the registrants in the CLP inventory.

Therefore, as per the CLP regulation, when determining the classification of mixtures (and UVCBs) containing components that are skin/eye irritants, the concentrations of the individual components must be compared against the generic concentration limits for the respective endpoints.

Based on the above criteria, the test substance ‘oils, vegetable, deodorizer distillates’ will not warrant any classification for skin and eye irritation potential as per the CLP Regulation EC/1272/2008 if the concentrations of octanoic and decanoic acid are present at <1% concentrations.

However, the test substance will warrant the following skin and eye irritation classification according to the CLP Regulation if the concentrations of octanoic and decanoic acid constituents exceed the general concentration limits as specified in Table 3.2.3 and 3.3.3 of the CLP guidance:

-       The substance will warrant a Skin Corr. 1; H314 classification according to the CLP Regulation if the concentration of driver classifying component (i.e., octanoic acid) is present at greater than the GCL (i.e. 5%). Further, in these cases, serious damage to the eyes is implicit and a separate classification for eye effects is not warranted as per the CLP Guidance.

-       The substance will warrant a Skin irrit. 2; H315 and Eye Damage 2; H318 classifications according to the CLP Regulation if octanoic acid present at ≥1% but < 3% and decanoic acid present at ≥10%.