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EC number: 500-241-6 | CAS number: 69011-36-5 1 - 2.5 moles ethoxylated
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: not sensitising
Read-across based on data obtained with the analogue source substance alcohols, C12-13, ethoxylated, < 2.5 EO (CAS No. 66455-14-9, EC No. 500-165-3).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the Analogue Approach Justification provided in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Group:
- positive control
- Remarks on result:
- other: no information available
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 66455-14-9, 1979, Shell, 79.133
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Source: CAS 66455-14-9, 1979, Shell, 79.133
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Source: CAS 66455-14-9, 1979, Shell, 79.133
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Source: CAS 66455-14-9, 1979, Shell, 79.133
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- No potential to induce skin sensitisation is predicted for the target substance considering an adequate analogue source substance.
- Executive summary:
The skin sensitisation potential of the target substance is predicted based on an adequate and reliable in vivo study performed with a structural analogue source substance. In the Guinea Pig Maximisation Test (GPMT), no skin sensitisation was observed in any animal of the test group neither at the first nor at the second reading. Therefore, no hazard regarding skin sensitisation is predicted for the target substance. As explained in the analogue read-across justification, the differences in composition and molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data on skin sensitisation of isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6) are available. In order to assess the skin sensitising potential, a study performed with the source substance alcohols, C12-13, ethoxylated, < 2.5 EO (CAS No. 66455-14-9, EC No. 500-165-3) is considered in an analogue read-across approach in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. The available source data allow for an accurate hazard assessment of the target substance. A detailed justification of the read-across approach is provided in IUCLID section 13.
The skin sensitising potential was assessed with alcohols, C12-13, ethoxylated, < 2.5 EO (CAS No. 66455-14-9, EC No. 500-165-3) in a Guinea Pig Maximisation Test equivalent (GPMT) according to OECD guideline 406 (Shell, 1979). In this study ten guinea pigs per sex were induced intradermally with 0.1% test substance (w/v, in corn oil), followed by epicutaneous occlusive induction for 48 h with undiluted test substance seven days later. Two weeks later animals were challenged by epicutaneous occlusive exposure for 24 h to 50% test substance (w/v, in corn oil). 24 and 48 h after patch removal the application site was assessed for signs of local irritation. No dermal reactions were observed in any test animal at any time point. Hence, the test substance was evaluated to be not sensitising to the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation with an adequate structural analogue substance 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 an analogue read-across approach, isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6) is predicted not to fulfil the classification criteria and is consequently not classified for skin sensitisation.
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