Registration Dossier

Diss Factsheets

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 skin sensitisation study is available for assessment. The study was performed with Polyol IXOL B251. Polyol IXOL B251 is a mixture consisting of 93-94% Polyol IXOL B350 and 6-7% triethyl phosphate (CAS number: 78-40-0). Based on the available data on triethyl phosphate as summarised in the OECD SIDS of that substance, it is not expected that 6-7% triethyl phosphate as present in Polyol IXOL B251 changes the toxicity profile significantly, i.e., the toxicity profiles of Polyol IXOL B350 and Polyol IXOL B251 are considered similar.

 

The skin sensitisation potential of Polyol IXOL B251 was investigated in a guinea pig maximisation test according to OECD guideline 406 (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:

- Freund’s Complete Adjuvant (FCA) 1:1 with water;

- 0.25% test substance in 5% (v/v) acetone in Alembicol D;

- 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 information available

Justification for classification or non-classification

Based on the available data, classification for skin sensitisation is not needed according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.