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EC number: 500-165-3 | CAS number: 66455-14-9 1 - 2.5 moles ethoxylated
Endpoint summary
Administrative data
Description of key information
Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
To cover the endpoint irritation of substance C12-13AE (CAS 66455-14-9), studies from similar substances were taken for a weight-of-evidence approach.
Read-across is justified because of the structural similarity of the AE Members. The degree of ethoxylation has no impact on the irritation potential due to its narrow range (1-2.5) within the category. According to a voluntary industry programme to carry out Human and Environmental Risk Assessments on ingredients of household cleaning products (HERA) the irritation potential of AEs is decreasing with increasing ethoxylation degree. The lower ethoxylation level of EO 1 - 3, which includes all read-across substances, appeared to be more irritating (HERA, 2009).
Since the category chemicals differ mainly from each other only by the number of -CH2- units (except for the unsaturated group), the category is very homogenous and it is assumed that each category member exhibits the same toxic mode of action.
Based on weight of evidence and interpolation on the given study reports the following subcategories for skin irritation can be derived:
Class I: short chain AEO (C6-11) ¿ not classified for skin irritation
Class II: detergent grade AEO (C12-15) ¿ not classified for skin irritation
Class III: saturated long chain AEO (C16-18) ¿ not classified for skin irritation
Class IV: unsaturated long chain AEO (C16/18 and C18 unsatd.) ¿ R38
For further information please refer to the category justification.The classification for skin irritation of C12-13AE observed within the study Cassidy (1979) is based on a very rigorous treatment of the animals with the test material. Exposure to the test material under occlusive conditions is significantly higher than under the current OECD 404 prescribed exposure under semi-occluded conditions. Higher exposures will likely result in more severe effects. Hence, the results from this study over predict the irritation potential when assessed against new OECD 404 guidance criteria and classification of the test material is not justified. This is proven by weight of evidence approach within the AE category justification. Exemplarily a read-across from the structural similar C12-13AE was performed showing that the criteria for classification as skin irritating are not met.
Regarding eye irritation, the test substance does not meet the criteria for classification according to 67/548/EEC and Regulation 1272/2008. This result is in line with the outcome of a trend analysis performed for eye irritating properties of the members of the AE Category to evaluate the impact of carbon chain length distribution on the eye irritating properties. All available studies, performed according to OECD Guideline 405 under GLP conditions, applying AE of a high purity (> 95%) and an ethoxylation degree = 2.5 and allowing the evaluation of the recovery (until day 21), were evaluated. According to this evaluation AE of the AE Category having a carbon chain length = C12 do not need to be classified for eye irritation/severe eye irritation. Based on this analysis C12-13AE (CAS 66455-14-9) is not classified for eye irritation. For further information please refer to the category justification.
Justification for selection of skin irritation / corrosion
endpoint:
Reliable OECD Guideline study
Justification for selection of eye irritation endpoint:
Reliable OECD Guideline study
Justification for classification or non-classification
According to the classification criteria of Regulation (EC) No. 1272/2008 the substance does not need to be classified for eye or skin irritation.
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