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Description of key information

Skin sensitisation: not sensitising

Read-across based on grouping of substances (category approach) considering all available data on skin sensitisation in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please refer to the category justification provided in the category object.
Key result
Group:
negative control
Remarks on result:
other: Not sensitising based on all available relevant skin sensitisation data in the Alcohol Ethoxylates (AE) category.
Key result
Group:
test chemical
Remarks on result:
other: Not sensitising based on all available relevant skin sensitisation data in the Alcohol Ethoxylates (AE) category.
Key result
Group:
positive control
Remarks on result:
other: Not sensitising based on all available relevant skin sensitisation data in the Alcohol Ethoxylates (AE) category.

For a detailed assessment of the skin sensitisation potential of the Alcohol Ethoxylates (AE) category, please refer to the category justification attached to the category object.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Applying read-across based on grouping of substances (category approach), no skin sensitisation potential is predicted for the target substance.
Executive summary:

The available data on skin sensitisation in the Alcohol Ethoxylates (AE) category indicate no skin sensitisation potential for the target substance. As explained in the category justification, the differences in molecular structure and composition between the target substance and the members of the AE category are unlikely to lead to differences in the skin sensitisation potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data on skin sensitisation are available for (Z)-9-octadecen-1-ol ethoxylated (CAS No. 9004-98-2, EC No. 500-016-2). In order to assess skin sensitisation, studies in the database of the Alcohol Ethoxylates (AE) category are considered in a read-across approach. Studies investigating skin sensitisation are available for the following AE substances:

 

CAS No.

EC No.

Substance

Study protocol

Hazard conclusion

27252-75-1

500-058-1

Octan-1-ol, ethoxylated

OECD 442E

Negative in the activation of dendritic cells

OECD 442D

Positive for keratinocyte activation

68439-50-9

500-213-3

Alcohols, C12-14, ethoxylated

OECD 406

Not sensitising

Similar OECD 406

Not sensitising

68439-49-6

939-518-5

Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO

OECD 406

Not sensitising

66455-14-9

500-165-3

Alcohols, C12-13, ethoxylated

Similar OECD 406

Not sensitising

 

Evaluation of skin sensitisation as observed in studies

All available study results indicate that AE substances have no potential to induce skin sensitisation. None of the category member substances turned out to be sensitising to skin in in vivo investigations (GPMT and Buehler test design), thus demonstrating similar toxicological properties. The maximum number of positively induced animals was 5 out of a group of 19 animals in the second study performed with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3). No animal showed a positive response in any of the other in vivo studies. The in vitro studies with octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) resulted in an inconclusive picture. A further investigation would be needed to finally conclude on the in vitro skin sensitisation potential of the substance. However, no further testing for the substance is warranted as it is corrosive to skin. In conclusion, the inconclusive assessment for octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) is not considered to invalidate the general findings of the in vivo studies, especially as this substance exhibits corrosive properties. Based on all available data on skin sensitisation in the AE category, it is established that the AE substances are not sensitising to skin.

This evaluation is considered sufficiently conclusive for the hazard assessment and classification and labelling of the AE substances. For a detailed evaluation of the skin sensitisation potential of the substances in the AE category, please refer to the category justification attached to the category object.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation obtained with members of the Alcohol Ethoxylates (AE) category do not meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. Based on grouping of substances (category approach), (Z)-9-octadecen-1-ol, ethoxylated (CAS No. 9004-98-2, EC No. 500-016-2) is predicted not to fulfil the classification criteria and is consequently not classified for skin sensitisation.