Registration Dossier
Registration Dossier
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EC number: 617-903-6 | CAS number: 86675-46-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A reliable skin sensitisation study, performed according to OECD Guideline 406 was available with the appropriate read-across candidate Polyol IXOL 350. In this study, the skin sensitisation potential of Polyol IXOL B350 was investigated in a guinea pig maximisation test (Huntingdon 1985). 20 test and 20 control guinea pigs (Dunkin-Hartley) were induced by 3 pairs of injections (0.1 mL) into the scapular region: (1) Freund’s Complete Adjuvant (FCA) 1:1 with water; (2) 0.25% test substance in 5% (v/v) acetone in Alembicol D; and (3) 0.25% test substance in a 1:1 mixture of 5% (v/v) acetone in Alembicol D and FCA. After one week, the test substance (as supplied, undiluted) was placed on the same area of skin for 48 hours under occlusive dressing. Two weeks following topical induction, challenge was performed with 5% (v/v) and 10% (v/v) of the test substance in acetone under occlusive dressing for 24 hours. No evidence of delayed contact hypersensitivity was seen in any of the twenty test animals.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No data available
Justification for classification or non-classification
Based on the findings in the skin sensitisation study with the structural analogue Polyol IXOL B350, Polyol IXOL M125 does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008
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