Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin, rabbit (read across, equivalent to OECD 404): not irritating

Eye, rabbit (read across, according to OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
weight of evidence
Justification for type of information:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean over
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: Source: CAS 3687-46-5
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean over
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Source: CAS 3687-46-5
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean over
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: Source: CAS 3687-46-5
Irritation parameter:
edema score
Basis:
animal: #1, #2
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 3687-46-5
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean over
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: Source: CAS 3687-46-5

In vivo skin irritation data from the source substance decyl octadec-9 -enoate (CAS 3687 -46 -5) were selected as key results for reasons of structural similarity and data reliability. Additional supporting in vivo data from the source substance 2 -octyldodecyl isooctadecanoate (CAS 93803 -87 -3) and Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0) did not show any skin irritation potential in rabbits.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The read across approach is justified in the analogue justification. Based on the available data, the target and the source substances are considered unlikely to differ in their skin irritation potential. No skin irritation potential leading to classification was found for the source substances decyl oleate (CAS 3687-46-5), 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), and Fatty acids, C8-10, C12-18-alkyl esters. Therefore, no skin irritation potential is expected for the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
weight of evidence
Justification for type of information:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Source: CAS 95912-88-2
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Source: CAS 95912-88-2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: Source: CAS 95912-88-2
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4
Remarks:
mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Source: CAS 95912-88-2

Based on structural similarity and data reliability, in vivo eye irritation data from the source substance Fatty acids, C16 -18, isotridecyl esters (CAS 95912 -88 -2) was presented as key results.

Additional in vivo eye irritation data is available for the source substance 2 -octyldodecyl isooctadecanoate (CAS 93803 -87 -3): In a study conducted according to OECD guideline 405 the individual mean conjunctivae score of readings over 24, 48 and 72 hours was 0.33, 0.0 and 0.0 for the three tested rabbits. The conjunctival finding in one animal was fully reversible within 48 hours. All other scores including iris, chemosis and corneal opacity were 0. No eye irritation potential was found in this study.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
The read across approach is justified in the analogue justification. Based on the available data, the target and the source substances are considered unlikely to differ in their eye irritation potential. No eye irritation potential was found for the source substances Fatty acids, C16 -18, isotridecyl esters (CAS 95912-88-2) and 2 -octyldodecyl isooctadecanoate (CAS 93803-87-3). Therefore, the no eye irritation potential is expected for the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for read-across

There are no adequate study data on the skin and eye irritation effects of Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS). The assessment was therefore based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Skin irritation

 

CAS 3687-46-5

A skin irritation study equivalent to OECD guideline 404 (WoE, 1994) was performed with Decyl oleate (CAS 3687-46-5). 0.5 mL of the liquid test substance was applied to the shaved skin of 3 male rabbits for 4 hours of exposure under semi-occlusive conditions. The local skin effects were scored 1, 24, 48 and 72 h, and 5 days after exposure ended. At the 24-h reading time point slight erythema (score 1) was observed in 2/3 animals and moderate erythema (score 2) was observed in 1/3 animals. At the 48-h and 72-h reading time points slight erythema (score 1) was still observed in 2/3 animals, while it had been fully reversible in the third animal. Oedema was observed in only 1/3 animals at the 24, 48 and 72-h reading. All findings at the 72-h reading were fully reversible within 5 days. The individual mean erythema scores over the 24, 48, and 72 h-readings were 1.00, 0.33, and 1.33 for the three animals. The individual mean oedema scores over the 24, 48, and 72 h-readings were 0.0, 0.0, and 1.0 for the three animals. Based on the results of this study, the test substance is not considered to be skin irritating.

 

CAS 93803-87-3

A study was performed according to OECD guideline 404 to assess the skin irritation potential of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) (WoE, 1998). 0.5 g test substance was applied to the shaved skin of rabbits under semi-occlusive conditions for 4 hours. 3/3 animals had well-defined erythema (score 2) at the 1-hr reading time point. The erythema had reduced in severity by 24 hours after exposure in 3/3 rabbits (score 1, 1, 1), and had cleared completely within 72 hours for 3/3 rabbits. The individual mean erythema scores over the 24, 48 and 72 evaluation times were 0.67, 0.33 and 0.33, respectively. The individual mean erythema and oedema scores over 24/48/72-hour readings were 0.0 for each rabbit. Based on the results of this study, the test substance is not considered to be skin irritating.

CAS 95912-86-0

A skin irritation study similar to OECD guideline 404 (WoE, 1991) was performed with Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0). 0.5 mL of the undiluted test substance was applied to the shaved skin of 3 male rabbits for 4 hours under occlusive conditions. The local skin effects were scored 1, 24, 48, and 72 h after exposure ended. At the 24-hour reading time point 1/3 rabbits showed erythema (score 1), which was fully reversible within 48 hours. Oedema was seen in 1/3 rabbits with score 2 at the 24-hour reading and score 1 at the 48 hour reading, which was fully reversible within 72 hours. The individual mean erythema scores (over 24, 48 and 72 hours) were 0.33, 0.0 and 0.0 while the mean oedema scores (over 24, 48 and 72 hours) were 1.0, 0.0 and 0.0. Based on the results of this study, the test substance is not considered to be skin irritating.

 

Eye irritation

 

CAS 95912-88-2

A study according to OECD guideline 405 (WoE, 1987) was done with Fatty acids, C16-18, isotridecyl esters. No eye irritation was seen after single instillation of 0.1 mL unchanged test substance without washing to one eye of 4 rabbits. The individual mean scores for cornea opacity, iris, conjunctivae and chemosis over the 24, 48, and 72 h-readings were 0.0 in each of the four animals. Based on the results of this study, the test substance is not considered to be irritating to the eyes.

 

CAS 93803-87-3

2-octyldodecyl isooctadecanoate (CA 93803-87-3) was examined for its eye irritation potential in a GLP study performed according to OECD guideline 405 (supporting study, 1998). 0.1 mL of undiluted test liquid test substance was instilled into one eye of each of 3 rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours after application. At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point. The individual mean cornea opacity, iris, and chemosis scores over 24/48/72-hour readings were 0.0 for each rabbit. The individual mean conjunctivae scores over 24/48/72-hour readings were 0.33 in one and 0.0 in two rabbits. Based on the results of this study, the test substance is not considered to be irritating to the eyes.

 

Overall conclusion for skin and eye irritation

The available data for the source substances indicate no or only mild skin and eye irritation potential. Thus, no skin or eye irritation potential is expected for the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS).

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". By applying the analogue concept to Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters (no CAS) data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

 

The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.

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