Registration Dossier

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Administrative data

Description of key information

Various literature data were available in rats for the irritation/corrosion potential of long chain alcohols (LCOH C14, C16, C18 chains), alkyl sulfates (AS C12 chain representing worst case situation for C14-C20) and sodium sulfate.

C14 LCHO and C12-Alkylsulfate, covering 2.4% of the registered substance, are classified Skin irritant CLP Category 2. LCOH16 and 18 and sodium sulfate, covering >85% of the registered substance, are not classified skin irritating or corrosive. Based on the generic concentration limits (CLP, 2008), the sum of the irritating ingredients is <10%, therefore the registered substance is not classified for skin irritation or corrosion.

C14 LCHO, covering 2.4% of the registered substance, is classified Eye irritant CLP Category 2, which is under the limit concentration of 10% for non-classification. LCOH16 and 18 and sodium sulfate, covering >85% of the registered substance, are not classified skin irritating or corrosive. Based on the generic concentration limits (CLP, 2008), the sum of the irritating/corrosive ingredients is <3%, therefore the registered substance is not classified for eye irritation or damage.

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
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS:
C12 > 98 %
25 % active substance
Species:
rabbit
Strain:
other: Kleinrusse Chbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation:
- Weight at study initiation: 2048 - 2308 g
- male animals
Type of coverage:
occlusive
Vehicle:
other: not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 25 % active substance was used


Duration of treatment / exposure:
4 hours
Observation period:
21 days
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: : 2.5 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not further specified

OBSERVATION TIME POINTS
1, 24, 48 and 72 hrs and on days 7, 10, 14, 17 and 21

SCORING SYSTEM:
- Method of calculation: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
3.4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
7 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
10 d
Score:
3.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
14 d
Score:
1.2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 17 days
Score:
0.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
21 d
Score:
0.4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
1.4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
3.4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
3.8
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
3.8
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
10 d
Score:
2.4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
14 d
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 17 days
Score:
0.4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
21 d
Score:
0.2
Max. score:
4
Reversibility:
not reversible
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the description of the lesions and the non-reversibility of the effects over the 21 days observation period it is considered that C12-Alkylsulfate is skin irritating.
Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 1 study according to OECD Guideline 404

Skin irritation was tested in male Kleinrusse Chbb:HM rabbits.

0.5 mL of test material (25% of the active substance) was applied in an area of 2.5 cm2. Observations were made until 21 days post application. Scoring system of Draize was used. Based on the description of the lesions and the non-reversibility of the effects over the 21 days observation period it is considered that C12-Alkylsulfate(SDS) is skin irritating.

 

Reference: Henkel KGaA (1987) Aniontenside, Kationtenside, Amphotenside, Niotenside - Pruefung auf primaere Hautirritation (Unpublished Report No. TBD 870150). Henkel KGaA, Duesseldorf, 21 pp.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
guideline study
Qualifier:
according to guideline
Guideline:
other: patch test based on OECD 404
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS: Tradename Lorol 14/Lorol C12-98
Species:
other: human volunteers
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 22-53 years with an average of 34.9 years.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 15 drops/plaster
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
20
Details on study design:
TEST SITE
- Area of exposure: 1.5 cm diameter
- Type of wrap if used: plaster (diameter: 1.5 cm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours after application

Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No irritation was observed following application to the human skin of undiluted test substance for 4 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No irritation was observed following application to the human skin of undiluted test substance for 4 hours.
Irritation parameter:
other: scaling and fissures
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: No irritation was observed following application to the human skin of undiluted test substance for 4 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
Lorol C14 is not irritating to human skin following a 4 hour semi-occlusive exposure in .
Executive summary:

The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Lorol 14) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 1 patch test in healthy human volunteers.

Fifteen drops of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of healthy volunteers with age between 22-53 years. 20 Male and female volunteers were tested. The observation of edema, erythema, scaling and fissures was made at 1, 24, 48 and 72 hours after application.

No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test). Lorol 14 is not irritating to human skin following a semi-occlusive exposure.

(Reference: Henkel KGaA, 1996 HD-Ocenol 90/95 V, Lorol C12-98, Lorol-C14-98, Lorol Spezial. 4h Patch Test (in Anlehnung an OECD Guideline Nr. 404). Henkel KGaA 1996, Report No. R9601427).

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
according to guideline
Guideline:
other: Contact laboratory protocol
Version / remarks:
1977
GLP compliance:
no
Specific details on test material used for the study:
OTHER SPECIFICS: Tradename Alfol 14
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: gum tragacanth 1%
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1mL (500 mg Alfol 14)
- Concentration (if solution): 50% in 1% gum tragacanth


Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure:1 inch square

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed off the treated skin
- Time after start of exposure: 72 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24, 48 and 72 hours after application

SCORING SYSTEM:
- Method of calculation: Draize et al, 1944
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
4.3
Max. score:
8
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
2.43
Max. score:
4
Reversibility:
not fully reversible within: 72 h. Erythema score intact: 2.4 at 72 h.
Remarks on result:
other: Individual scores 5/6 greater than 2.3
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Time point:
24/48/72 h
Score:
2.53
Max. score:
4
Reversibility:
not fully reversible within: 72 h. Erythema score abraded: 2.8 at 72 h.
Remarks on result:
other: Individual scores 5/6 greater than 2.3
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
1.83
Max. score:
4
Reversibility:
not fully reversible within: 72 h; Edema score abraded 1.5 at 72 h.
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
mean
Time point:
24/48/72 h
Score:
3.26
Max. score:
4
Reversibility:
not fully reversible within: 72 h. Edema score intact: 1.3 at 72 h.
Irritant / corrosive response data:
Erythema increased or persisted until 72 hours after application while oedema decreased or persisted.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Based on the erythema and oedema scores reported Alfol 14 would be considered a skin irritant according to EU criteria and a class 2 irritant according to GHS criteria. Individual 24+48+72 hour erythema scores were >2.3 in 5/6 animals while the group mean 24+48+72 hour score was also in excess of 2.3 (2.46).
Executive summary:

The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Alfol 14) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 2 study according to contract laboratory protocol in 6 New Zealand White rabbits (1977).

500 mg Alfol 14 was applied at a volume of 1 mL as a 50% suspension in 1% of gum tragacanth to 1 inch square of intact and abraded skin for a 24 hours occlusive exposure. After 24 hours the test substance was washed off the treated skin.

Observations were made 24, 48 and 72 hours post application. Scoring system of Draize was used.

The average score after 24+48+72 hours were

- Erythema: Intact skin 2.43, abraded skin 2.53 (72 hours score intact 2.4, abraded 2.8).

- Oedema: intact skin 1.83, abraded skin 3.26 (72 hours score intact 1.3, abraded 1.5.).

Alfol 14 was considered skin irritant according to EU criteria and a class 2 irritant according to GHS criteria.

(Reference: Scientific Associates, Inc. 1977b. Acute oral toxicity (LD50) in rats, acute dermal toxicity (LD50) in rabbits, dermal irritation test in rabbits, eye irritation test in rabbits, and inhalation toxicity test in rats. ALFOL 14 alcohol.)

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:
data from handbook or collection of data
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS: Tradename Kalcol 6098
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival, Cheshire, UK
- Age at study initiation: 12 -16 weeks
- Weight at study initiation: 2.36 - 2.54 kg
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: The test material was a white solid, the test site was moistened with 0.5 mL purified water prior to application of 0.5 g of the solid.
Controls:
other: not reported
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the solid


VEHICLE
- Amount(s) applied (volume or weight with unit): the test site was moistened with 0.5 mL purified water prior to application of 0.5 g of the solid.

Duration of treatment / exposure:
4 hours
Observation period:
Postexposure period: 16 days
Number of animals:
3 (2 male, 1 female)
Details on study design:
TEST SITE
- % coverage: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours post application.

SCORING SYSTEM:
- Method of calculation: Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within: 24 hours
Remarks:
Initial erythema regressed in the first 24 hours. All scores at 24, 48 and 72 hours were 0.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Erythema (grade 1) observed at 1 hour after removal of dressings. All scores at other time points 0.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: No oedema observed.
Interpretation of results:
GHS criteria not met
Conclusions:
Following a 4 hour semi-occlusive exposure of Kalcol 6098 to rabbit skin there was no evidence of skin irritation between 24 and 72 hours after patch removal. All erythema and oedema scores at 24, 48 and 72 hours were 0 and primary dermal irritation index was 0 . Kalcol 6098 is not a skin irritant according to EU or GHS criteria.
Executive summary:

The IUCLID dataset of 1-Hexadecanol (CAS 36653-82-4, Tradename Kalcol 6098) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes one Klimisch 1 study according to OECD TG 404 in 3 New Zealand White rabbits.

The test material was a white solid, the test site was moistened with 0.5 mL purified water prior to semi-occlusive application of 0.5 g of the solid on an area of 2.5 x 2.5 cm. After 4 hours exposure the test substance was removed by gentle swabbing with cotton.

Observations were made 1, 24, 48 and 72 hours post application. Scoring system of Draize was used. Post-exposure period was 16 days.

Erythema (grade 1) was observed at 1 hour after removal of dressings. All scores at other time points were 0. No oedema observed. Initial erythema regressed in the first 24 hours. All scores at 24, 48 and 72 hours were 0. Primary dermal irritation index was 0.

Following a 4 hour semi-occlusive exposure of Kalcol 6098 to rabbit skin there was no evidence of skin irritation between 24 and 72 hours after patch removal. Kalcol 6098 is not a skin irritant according to EU or GHS criteria.

(Reference: Sanders, A. 1996b.Kalcol 6098: Acute dermal irritation test in the rabbit. SPL Project Number 140/496.)

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS: Tradename Kalcol 8098
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation:12-16 weeks
- Weight at study initiation: 2.56 - 2.73 kg

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: The test material was a white solid, the test site was moistened with 0.5 ml distlled water prior to application.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the solid.

VEHICLE
- Amount(s) applied (volume or weight with unit): the test site was moistened with 0.5 mL distilled water prior to application of 0.5 g of the solid.

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: .2,5 x 2.5 cm


OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24, 48 and 72 hours post application

SCORING SYSTEM:
- Method of calculation: Draize
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Reversibility:
other: not applicable, not irritating
Remarks on result:
other: No evidence of skin irritation was noted during the study, all scores were 0.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Following a 4 hour semi-occlusive exposure to rabbits skin Kalcol 8098 was non-irritating to rabbit skin. All erythema and oedema scores at 24, 48 and 72 hours in rabbits were 0 and primary dermal irritation index was 0. Kalcol 8098 is not a skin irritant according to EU or GHS criteria.
Executive summary:

The IUCLID dataset of 1-Octadenol (CAS 112-92-5) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 1 study according to OECD Guideline 404 "Acute Dermal Irritation/Corrosion" in 3 New Zealand White rabbits.

The test material was a white solid, the test site was moistened with 0.5 mL distilled water prior to semi-occlusive application of 0.5 g of the solid on an area of 2.5 x 2.5 cm. The exposure period was 4 hours, the post-exposure preiod was 72 hours. Observations were made 24, 48 and 72 hours post application. Scoring system of Draize was used.

Primary dermal irritation index was 0. No evidence of skin irritation was noted during the study, all scores were 0.

Following a 4 hour semi-occlusive exposure to rabbits skin, Kalcol 8098 was non-irritating. Kalcol 8098 is not a skin irritant according to EU or GHS criteria.

(Reference: Sanders, A. 1996c. Kalcol 8098: Acute dermal irritation test in the rabbit. SPL Project Number 140/502.)

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
no deviations reported
GLP compliance:
yes
Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna, Ltd, UK
- Age at study initiation: adults
- Weight at study initiation: 3.7 - 4.2 kg


Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: polyethyleneglycol 400
Remarks:
PEG 400
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (500 mg pulverized in PEG 400)

NEGATIVE CONTROL
Contralateral skin area not treated

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorso-lateral areas of the trunk.
- Type of wrap if used: Patches hypoallergenic Hansamed (Beiersdorf)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
-1, 24, 48, 72 hours, 7, 14 days.

SCORING SYSTEM:
- Method of calculation: DRAIZE
Irritation parameter:
erythema score
Basis:
mean
Time point:
14 d
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
14 d
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
Not irritating.
Executive summary:

The IUCLID dataset of Na2SO4 (CAS 7757 -82 -6) in the OECD SIDS INITIAL ASSESSMENT PROFILE of Sodium sulfate describes the following Klimisch 1 study according to OECD Guideline 404.

Skin irritation was tested under occlusive conditions in 3 HC:NZW rabbits. 500 mg of test material was pulverized in PEG 400 and applied on the dorso-lateral area of the trunk and covered for 4 hours with hypoallergenic Hasamed patches. Observations were made until 14 days post application. Scoring system of Draize was used. Sodium sulfate is considered not skin irritating.

 

Reference: Bayer, A.G.(1991) Study for skin and eye irritation/corrosion in rabbits. Unpublished report. Study no. T7039997, Report no. 20338, Wuppertal, Germany.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS: C12 > 98 %
Species:
rabbit
Strain:
other: Kleinrusse Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae, Germany
- Weight at study initiation: 2092 - 2478 g
- male animals
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1mL
- Concentration (if solution): 25 % active substance


Duration of treatment / exposure:
single instillation, not rinsed
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: 0.5 % aqueous fluorescein (cornea)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 6 hours
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
10 d
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
14 d
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 17 days
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
21 d
Score:
0.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
other: 1 h
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
other: 6 h
Score:
1.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
48 h
Score:
3.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
72 h
Score:
3.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
7 d
Score:
2.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
10 d
Score:
2.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
14 d
Score:
2.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
other: 17 d
Score:
2.25
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: area of cornea involved
Basis:
mean
Time point:
21 d
Score:
1.75
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 6 hours
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24 h
Score:
2.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
48 h
Score:
2.75
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
72 h
Score:
2.75
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
7 d
Score:
2.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
10 d
Score:
1.5
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
14 d
Score:
1.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 17 days
Score:
1.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
21 d
Score:
1.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h
Score:
1.25
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 6h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
1.25
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
10 d
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
14 d
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 17 days
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
21 d
Score:
0
Max. score:
4
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
other: 1 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
other: 6h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
48 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
7 d
Score:
1
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
10 d
Score:
2.25
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
14 d
Score:
1.75
Max. score:
3
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
other: 17 d
Score:
1.75
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
other: conjunctivae discharge
Basis:
mean
Time point:
21 d
Score:
0.75
Max. score:
3
Reversibility:
not reversible
Other effects:
Cornea (0.5 % aqueous fluorescein): mean 100 or 40 after 24 hrs or 21 days p.a.
Interpretation of results:
GHS criteria not met
Conclusions:
Sodium dodecyl sulfate was highly corrosive for the eyes in this in vivo test in rabbits.
Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 1 study according to OECD Guideline 405.

0.1 mL of the test material was applied in the eyes of 4 male Kleinrusse Chbb:HM rabbits as a solution in water at a concentration 25% of active substance. The eyes were not rinsed.

Observations were made until 21 days post application. Scoring system of Draize was used.

Based on the description of the lesions and the non-reversibility of the effects over the 21 days observation period it is considered that C12-Alkylsulfate (SDS) is highly corrosive for the eyes.

 

Reference:Henkel KGaA (1987) Texapon L 100, Lanette E, Maranil A Paste 75, Texapon T 42, Texapon N 25, Texapon SB 3, Texapon ASV, Nifancol LBE, Forlanit E und Akypro RLM 100.Pruefung auf primaere Schleimhautirritation am Kaninchenauge (Unpublished Report No. TBD 870553). Henkel KGaA, Duesseldorf, 20 pp

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS:Tradename Kalcol 4098
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.56- 2.80 kg

Vehicle:
other: polyethylene glycol 400
Controls:
other: Untreated eye used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10% solution in polyethylene glycol 400.



Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize and modified Kay and Calandra.

TOOL USED TO ASSESS SCORE: Standard ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 48 hours. All treated eyes appeared normal 48 and 72 hours after instillation.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours. All treated eyes appeared normal 48 and 72 hours after instillation.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Irritation parameter:
overall irritation score
Remarks:
maximulm group
Basis:
mean
Time point:
other: 1 hour post instillation
Score:
8.7
Max. score:
110
Remarks on result:
other:
Remarks:
Described as a minimal eye irritant according to modified Kay & Calandra.
Irritant / corrosive response data:
At 1 hour post instillation Grade 2 redness of the conjunctival membrane was noted in 2 treated eyes with grade 1 redness of the conjunctival membrane noted in the remaining treated eye. Conjunctival redness (grade 1) persisted in in 2 treated eyes at the 24 hour observation. Chemosis was also observed in all eyes at 1 hour post instillation (grade1 and 2) persisting in one treated eye until 24 hours. Grade 3 discharge was noted in 1 treated eye with grade 1 noted in one other treated eye at the 1 hour observation. No other evidence of eye irritation was noted during the study.
Interpretation of results:
GHS criteria not met
Conclusions:
When instilled into the rabbit eye as a 10% solution in polyethylene glycol 400, Kalcol 4098 was not classified as an eye irritant by either EU or GHS criteria.
Executive summary:

The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Kalcol 4098) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 1 study according to OECD TG 405 in 3 New Zealand White rabbits.

The test material was prepared as a 10% solution in polyethylene glycol 400 and 0.1 mL was applied in the eye.

Observations were made until 72 hours post application. Scoring system of Draize and modified scoring system of Kay and Calandra were used.

At 1 hour post instillation Grade 2 redness of the conjunctival membrane was noted in 2 treated eyes with grade 1 redness of the conjunctival membrane noted in the remaining treated eye. Conjunctival redness (grade 1) persisted in in 2 treated eyes at the 24 hour observation. Chemosis was also observed in all eyes at 1 hour post instillation (grade1 and 2) persisting in one treated eye until 24 hours. Grade 3 discharge was noted in 1 treated eye with grade 1 noted in one other treated eye at the 1 hour observation. No other evidence of eye irritation was noted during the study.

When instilled into the rabbit eye as 10% solution in polyethylene glycol 400, Kalcol 4098 was not classified as an eye irritant according to EU or GHS criteria.

 

(Reference: Hempstock, C. 1997b. Kalcol 4098 (10%): Acute eye irritation test in the rabbit. SPL Project Number 140/780R)

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS:Tradename Kalcol 4098
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.67-2.94 kg

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (ca 46 mg)
Duration of treatment / exposure:
not rinsed, single exposure
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize and modified Kay and Calandra.

TOOL USED TO ASSESS SCORE: Standard ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: All corneal scores were normal by day 7.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.43
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
1.47
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.23
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Irritation parameter:
overall irritation score
Remarks:
maximum group
Basis:
mean
Time point:
24 h
Score:
27.3
Max. score:
110
Remarks on result:
other: The substance is classified as a moderate irritant according to Kay and Callandra .
Irritant / corrosive response data:
Diffuse corneal opacity was noted in 2 treated eyes at the 24, 48, and 72 hour observations. Iridial inflammation was noted in 2 treated eyes at the 24 hour observation and persisted in 1 treated eye at the 48 and 72 hour observations. Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment and persisted in 2 treated eyes at the 24 and 48 hour observations. Minimal conjunctival irritation was noted in 1 treated eye at the 24 and 48 hour observations and in 2 treated eyes at the 72 hour and 7 day observation.
All corneal and iridial scores and scores for conjunctival chemosis were normal by day 7. Conjunctival redness persisted in 2 rabbits through day 7 but scores were 0 by day 14. The effects were therefore fully reversible.
Discharge was observed from all treated eyes 1 hour after instillation and persisted in one eye for 48 hours and in another for 72 hours. All eyes were clear at 7 days.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Kalcol 4098 applied as a powder is classified as category 2 eye irritant according to GHS criteria based on corneal opacity of >= 1 in 2 test animals and persistence beyond 7 days. Effects were fully reversible by day 14.
Executive summary:

The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Kalcol 4098) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 1 study according to OECD TG 405 in 3 New Zealand White rabbits.

The test material was solid and was ground to a fine powder prior to instillation and 0.1 mL( ca 46mg) was applied in the eye using an adapted syringe. No rinsing was performed.

Observations were made until 14 days post application. Scoring system of Draize and modified scoring system of Kay and Calandra were used.

Diffuse corneal opacity was noted in 2 treated eyes at the 24, 48, and 72 hour observations. Iridial inflammation was noted in 2 treated eyes at the 24 hour observation and persisted in 1 treated eye at the 48 and 72 hour observations. Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment and persisted in 2 treated eyes at the 24 and 48 hour observations. Minimal conjunctival irritation was noted in 1 treated eye at the 24 and 48 hour observations and in 2 treated eyes at the 72 hour and 7 day observation.

Kalcol 4098 applied as a powder is not classifiable as an eye irritant according to EU criteria. Kalcol 4098 is however a category 2A eye irritant according to GHS criteria based on corneal opacity of >= 1 in 2 test animals and persistence beyond 7 days. Effects were fully reversible by day 14.

 

(Reference: Sanders, A. 1996f. Kalcol 4098: Acute eye irritation test in the rabbit. SPL Project Number140/596).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
according to guideline
Guideline:
other: contract laboratory protocol
GLP compliance:
not specified
Specific details on test material used for the study:
OTHER SPECIFICS:Tradename Alfol 14
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
The treated eyes were rinsed after 24 hours to remove residual test material.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed
- Time after start of exposure: 24 hours

SCORING SYSTEM: The scores were reported as prescribed by the FDA 1965.

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
6.7
Reversibility:
other: By the end of the 72 hour observation period there was no involvement of the iris or cornea. Minimal to slight redness and barely perceptible to moderate chemosis were still evident.
Remarks on result:
other: The scores were reported as prescribed by the FDA 1965. Although individual animal data was provided only the converted scores were reported so it is not possible to present the data according to EC/GHS criteria.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
18
Reversibility:
other: By the end of the 72 hour observation period there was no involvement of the iris or cornea. Minimal to slight redness and barely perceptible to moderate chemosis were still evident.
Remarks on result:
other: The scores were reported as prescribed by the FDA 1965. Although individual animal data was provided only the converted scores were reported so it is not possible to present the data according to EC/GHS criteria.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
12.5
Reversibility:
other: By the end of the 72 hour observation period there was no involvement of the iris or cornea. Minimal to slight redness and barely perceptible to moderate chemosis were still evident.
Remarks on result:
other: The scores were reported as prescribed by the FDA 1965. Although individual animal data was provided only the converted scores were reported so it is not possible to present the data according to EC/GHS criteria.
Remarks:
T
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
6
Reversibility:
other: By the end of the 72 hour observation period there was no involvement of the iris or cornea. Minimal to slight redness and barely perceptible to moderate chemosis were still evident.
Remarks on result:
other: The scores were reported as prescribed by the FDA 1965. Although individual animal data was provided only the converted scores were reported so it is not possible to present the data according to EC/GHS criteria.
Irritant / corrosive response data:
Cornea: opacity slight to easily discernible involving 1/4 to 3/4 of the corneal surface observed in all animals. At 72 hours there was no corneal involvement in any animal.
Iris: barely perceptible to minimal iritis (grade 1) in 1/6 rabbits at 24 hours after instillation. No iritis at 48 or 72 hours.
Conjunctivae (Redness): Slight to moderate conjuctivitis in all eyes from 24 hours. At 72 hours there was minimal to slight redness in 6/6.
Conjunctivae (Chemosis): Minimal to pronounced chemosis of the eye lids with a slight watery-mucoid discharge in all animals. At 72 hours barely perceptible to moderate chemosis 4/6 and slight discharge 2/6.
There was a gradual improvement in all animals.
By the end of the 72 hour observation period there was no involvement of the iris or cornea. Minimal to slight redness and barely perceptible to moderate chemosis were still evident.
Interpretation of results:
study cannot be used for classification
Remarks:
Based on the description of the lesions and the consistent reduction of severity of the effects over the 72 hours observation period
Conclusions:
Based on the description of the lesions and the consistent reduction of severity of the effects over the 72 hours observation period it is considered that Alfol 14 is not classifiable as an eye irritant according to EU or GHS criteria.
Executive summary:

The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Alfol 14 ) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 2 study according to contract laboratory protocol in 6 New Zealand White rabbits.

The test material was applied in the eye as a solid at a dose of 100 mg. The treated eyes were rinsed after 24 hours to remove residual test material. The other eyes served as control. Observations were made until 72 hours post application. Scoring system of FDA 1965 was used. Although individual animal data was provided, only the converted scores were reported, so it is not possible to present the data according to EC/GHS criteria.

The average score (includes all end points) for each time point was as follows:

1 hour: 6.7

24 hours: 18

48 hours: 12.5

72 hours: 6

The following lesions were observed:

Cornea: opacity slight to easily discernible involving 1/4 to 3/4 of the corneal surface observed in all animals. At 72 hours there was no corneal involvement in any animal.

Iris: barely perceptible to minimal iritis (grade 1) in 1/6 rabbits at 24 hours after instillation. No iritis at 48 or 72 hours.

Conjunctivae (Redness): Slight to moderate conjunctivitis in all eyes from 24 hours. At 72 hours there was minimal to slight redness in 6/6.

Conjunctivae (Chemosis): Minimal to pronounced chemosis of the eye lids with a slight watery-mucoid discharge in all animals. At 72 hours barely perceptible to moderate chemosis 4/6 and slight discharge 2/6.

Based on the description of the lesions and the consistent reduction of severity of the effects over the 72 hours observation period it is considered that Alfol 14 is not classifiable as an eye irritant according to EU or GHS criteria.

(Reference: Scientific Associates, Inc. 1977b. Acute oral toxicity (LD50) in rats, acute dermal toxicity (LD50) in rabbits, dermal irritation test in rabbits, eye irritation test in rabbits, and inhalation toxicity test in rats. ALFOL 14 alcohol.)

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS: Tradename Kalcol 6098
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.69-3.01 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (ca. 78 mg)
White granular solid applied using an adapted syringe.
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize and modified Kay and Callandra

TOOL USED TO ASSESS SCORE: Standard ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Irritation parameter:
overall irritation score
Remarks:
maximum group
Basis:
mean
Time point:
other: at 1 h post instillation.
Score:
15.3
Max. score:
110
Reversibility:
fully reversible within: 48 h. All eyes were normal at 48 and 72 hours post instillation.
Remarks on result:
other: Classified as a mild irritant according to a modified Kay and Calandra system.
Irritant / corrosive response data:
Dulling of the cornea noted in 2 animals 1 hour after instillation, diffuse corneal opacity noted in 1 rabbit at 24 hours post instillation. Iridial inflammation noted in 2 animals at 1 hour post instillation only. Moderate conjunctival irritation noted in all eyes at 1 hour which reduced to minimal conjunctival irritation at 24 hours. All eyes were normal at 48 and 72 hours post instillation.
Other effects:
- Other observations: Residual test material noted around the treated eyes at 1 hour post instillation.
Interpretation of results:
GHS criteria not met
Conclusions:
Moderate conjunctival irritation was noted in all eyes at 1 hour which reduced to minimal conjunctival irritation at 24 hours. All eyes were normal at 48 and 72 hours post instillation. Kalcol 6098 is not an eye irritant according to EU or GHS criteria.
Executive summary:

The IUCLID dataset of 1-Hexadecanol (CAS 36653-82-4, Tradename Kalcol 6098) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 1 study according to OECD TG 405 in 3 New Zealand White rabbits.

The test material was a white granular solid and 0.1 mL was applied in the eye using an adapted syringe.

Observations were made until 72 hours post application. Scoring system of Draize and modified scoring system of Kay and Calandra were used.

Dulling of the cornea noted in 2 animals 1 hour after instillation, diffuse corneal opacity noted in 1 rabbit at 24 hours post instillation. Iridial inflammation noted in 2 animals at 1 hour post instillation only. Moderate conjunctival irritation was noted in all eyes at 1 hour which reduced to minimal conjunctival irritation at 24 hours. All eyes were normal at 48 and 72 hours post instillation.

Kalcol 6098 is not an eye irritant according to EU or GHS criteria.

(Reference: Sanders, A. 1996g. Kalcol 6098: Acute eye irritation test in the rabbit. SPL Project Number 140/498)

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
OTHER SPECIFICS:Tradename Kalcol 8098
Species:
rabbit
Strain:
New Zealand White
Remarks:
1 male, 2 females
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.90-3.23 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL (ca 82 mg)
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize and modified Kay and Calandra

TOOL USED TO ASSESS SCORE: Standard ophthalmoscope
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48h.
Remarks:
All eyes scored 0 at 48 and 72 hours post instillation.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 48 h.
Remarks:
All eyes scored 0 at 48 and 72 hours post instillation.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.43
Max. score:
3
Reversibility:
fully reversible within: 48 h.
Remarks:
All eyes scored 0 at 48 and 72 hours post instillation.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h.
Remarks:
All eyes scored 0 at 48 and 72 hours post instillation.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Irritation parameter:
overall irritation score
Remarks:
maximum group
Basis:
mean
Time point:
other: 1 hour
Score:
10
Max. score:
110
Reversibility:
fully reversible within: 48 h.
Remarks:
All eyes scored 0 at 48 and 72 hours post instillation.
Remarks on result:
other: Classified as a mild irritant
Remarks:
Scoring system: Draize and modified Kay and Callandra
Irritant / corrosive response data:
The application of the test material produced diffuse corneal opacity restricted to one treated eye at 24 hours. Iridial inflammation was noted in 2 eyes at 1 hour and one at 24 hours. Minimal to moderate conjunctival irritation was reported at 1 hour with minimal conjunctivitis in 2 eyes at 24 hours.
Other effects:
Residual test material noted around all eyes at the 1 hour observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
Iridial inflammation was noted in 2 eyes at 1 hour and one at 24 hours. Minimal to moderate conjunctival irritation was reported at 1 hour with minimal conjunctivitis in 2 eyes at 24 hours.
All eyes scored 0 at 48 and 72 hours post instillation. Kalcol 8098 is not an eye irritant according to EU or GHS criteria.
Executive summary:

The IUCLID dataset of 1-Octadenol (CAS 112-92-5, Tradename Kalcol 8098) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 1 study according to OECD TG 405 in 3 New Zealand White rabbits.

0.1 mL (ca 82 mg) of the test material was applied in the eye as a solid using an adapted syringe.

Observations were made until 72 hours post application. Scoring system of Draize and modified scoring system of Kay and Calandra were used.

The application of the test material produced diffuse corneal opacity restricted to one treated eye at 24 hours. Iridial inflammation was noted in 2 eyes at 1 hour and one at 24 hours. Minimal to moderate conjunctival irritation was reported at 1 hour with minimal conjunctivitis in 2 eyes at 24 hours.

All eyes scored 0 at 48 and 72 hours post instillation.

Kalcol 8098 is not an eye irritant according to EU or GHS criteria. Effects were fully reversible after 72 hours post instillation.

(Reference: Sanders, A. 1996h. Kalcol 8098: Acute eye irritation test in the rabbit. SPL Project Number 140/504)

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Remarks:
no deviations reported
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Remarks:
no deviations reported
GLP compliance:
yes
Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna, Ltd, UK
- Age at study initiation: adults

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 90 mg pulverized powder; 100 µL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
not specified
Interpretation of results:
GHS criteria not met
Conclusions:
Slightly irritating.
Executive summary:

The IUCLID dataset of Na2SO4 (CAS 7757 -82 -6) in the OECD SIDS INITIAL ASSESSMENT PROFILE of Sodium sulfate describes the following Klimisch 1 study according to OECD Guideline 405.

Eye irritation was tested in 3 HC:NZW rabbits. 90 mg of test material was instilled in the conjunctival sac of the eye for 24 hours exposure. Observations were made until 21 days post application. Scoring system of Draize was used. The positive effects were primarily based on the conjunctivae (redness) observed in the test. The effects were reversible within 7 days. Sodium sulfate appears to be slightly irritating to the eye in rabbit.

 

Reference: Bayer, A.G.(1991) Study for skin and eye irritation/corrosion in rabbits. Unpublished report. Study no. T7039997, Report no. 20338, Wuppertal, Germany.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No extra testing was performed as literature data were available as weight-of-evidence/supporting data for the various components of the registered substances. A selection of most reliable sources (Klimisch 1-2) was made.In vitro testing was waived as adequate data from in vivo studies was available.

Skin irritation/corrosion:

-      Various literature data were available in rabbits after application of 0.5 g on the skin and in humans after patch testing for the long chain alcohols (LCHO) with chain length between C14 and C18, as summarised below.

-      For LCOH 14 (Alfol 14; 1-Tetradecanol;CAS 112-72-1) erythema and oedema scores were >2.3 in 5/6 rabbits while the group mean 24+48+72 hour > 2.3 (2.46) (SIDS, 2006; Scientific Associates, Inc. 1977), however no irritation was observed in human volunteers by patch testing (SIDS, 2006; Henkel 1996). -      For LCOH 16 (1-Hexadecanol; CAS 36653-82-4) all erythema and oedema scores at 24, 48 and 72 hours in rabbits were 0 and primary dermal irritation index was 0 (SIDS, 2006; Sanders, 1996b).

-      For LCOH 18 (1-Octadecanol; CAS 112-925) all erythema and oedema scores at 24, 48 and 72 hours in rabbits were 0 and primary dermal irritation index was 0 (SIDS, 2006; Sanders, 1996c). For thealkyl sulfates (AS), there were no data for the C14-C20 chain lengths, however literature data were available for the C12 chain length after application of 0.5 g on the rabbit skin. The C12 AS can be considered as a worst case substance.

-      For C12-Alkylsulfate (CAS 151-21-3) there were lesions and due the non-reversibility of the effects over the 21 days observation period it is considered that C12-Alkylsulfate is skin irritating (SIDS, 2007; Henkel, 1987).

For the sodium sulfate, literature data were available:

-      For Sodium sulfate (CAS 7757 -82 -6) skin irritation was tested in 3 rabbits did not result in observations up to 14 days post application (SIDS 2005; Bayer, 1991). Eye irritation/corrosion: Various literature data were available in rabbits after instillation of 0.1 g in the eye for the long chain alcohols (LCHO) with chain length between C14 and C20, as summarised below.

-      For LCOH 14 (Alfol 14; 1-Tetradecanol;CAS 112-72-1) corneal opacity of>1 was observed in 2 rabbits, persisting beyond 7 days and fully reversible by day 14 (SIDS, 2006; Sanders, 1996f), however when instilled into the rabbit eye as a 10% solution in polyethylene glycol 400, no irritation was observed (SIDS, 2006; Hempstock 1997b). A supporting study in rabbits, reduction of severity of the effects was observed over the 72 hours observation, however scores do not comply with GHS and cannot be used for classification (SIDS, 2006; Scientific Associates, Inc. 1977b).

-      For LCOH 16 (1-Hexadecanol; CAS 36653-82-4) moderate conjunctival irritation was noted in all eyes at 1 hour which reduced to minimal conjunctival irritation at 24 hours; all eyes were normal at 48 and 72 hours post instillation (SIDS, 2006; Sanders, 1996g).

-      For LCOH 18 (1-Octadecanol; CAS 112-925) iridial inflammation was noted in 2 eyes at 1 hour and 1 eye at 24 hours. Minimal to moderate conjunctival irritation was reported at 1 hour with minimal conjunctivitis in 2 eyes at 24 hours. All eyes scored 0 at 48 and 72 hours post instillation (SIDS, 2006; Sanders, 1996h).  

For the alkyl sulfates, there were no data for the C14-C20 chain lengths, however literature data were available for the C12 chain length after instillation of 0.1 g in the rabbit eye:

-      For C12-Alkylsulfate (CAS 151-21-3) a concentration of 25% resulted in eye lesions within 1 hour that were non-reversible and corrosive for the eyes (SIDS, 2007; Henkel, 1987). For the sodium sulfate, literature data were available: -      For Sodium sulfate (CAS 7757 -82 -6) skin irritation was tested in 3 rabbits did not result in observations up to 14 days post application (SIDS 2005; Bayer, 1991).

-      Conclusion: C14 LCHO and C12-Alkylsulfate, covering 2.4% of the registered substance, are classified Skin irritant CLP Category 2. LCOH16 and 18 and sodium sulfate, covering 88% of the registered substance, are not classified skin irritating or corrosive. Based on the generic concentration limits (CLP, 2008), the sum of the irritating ingredients is <10%, therefore the registered substance is not classified for skin irritation or corrosion. C14 LCHO, covering 2.4% of the registered substance, is classified Eye irritant CLP Category 2, limit concentration of 10% for non-classification.C12-Alkylsulfate 25% covering 0% of the registered substance, is Eye corrosive CLP Category 1. LCOH16 and 18 and sodium sulfate, covering 88% of the registered substance, are not classified skin irritating or corrosive. Based on the generic concentration limits (CLP, 2008), the sum of the irritating/corrosive ingredients is <3%, therefore the registered substance is not classified for eye irritation or damage.

Justification for classification or non-classification

Based on these results and according to CLP (No. 1272/2008 of 16 December 2008), the registered substance does not have to be classified and has no obligatory labelling requirement for skin and eye irritation/corrosion.