2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated

Endpoint summary

Description of key information

The substance was irritating to the eyes of rabbits. Skin irritation (rabbits) was not observed.

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:

adverse effect observed (irritating)

Additional information

A skin and an eye irritation study are available for assessment. Both studies were 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 primary skin irritation potential of Polyol IXOL B251 to the rabbit skin was investigated in a study performed according to OECD guideline 404 and under GLP (Duphar B.V., 1985b). 0.5 g of the test substance was applied on the shaven non-abraded skin of three rabbits and occluded under patches for four hours. The patches were removed, and readings of the reactions for erythema and edema were made at 30-60 minutes and at 24, 48 and 72 hours after patch removal. There was neither erythema nor edema at any of the readings and therefore the test substance is considered not to be irritating to the shaven non-abraded rabbit skin.

The primary irritation of Polyol IXOL B251 to the rabbit eye was investigated in a study performed according to OECD guideline 405 and under GLP (Duphar B.V., 1985c). To this purpose, 0.1 ml of the test substance was placed into the conjunctival sac of one eye of three male rabbits of the New Zealand White strain. The eyes were examined and the ocular reactions graded at 1 hour, at 24, 48 and 72 hours and at 7, 9 and 12 days after treatment.

The conjunctivae of all rabbits (individual animal mean (24, 48 and 72 hours) scores: 1.3, 1.7 and 2) and the cornea of two rabbits (two animals with a mean (24, 48 and 72 hours) cornea opacity score >1 (1.7 and 1.3, resp.)) were slightly to moderately irritated the first two days after treatment. The effects had disappeared at 7 days after application in one rabbit, while in the other two rabbits a slight redness of the conjunctiva was still observed, which had disappeared 12 days after application. The mean (24, 48 and 72 hours) chemosis score was 1 (individual animal mean (24, 48 and 72 hours) scores: 0.7, 1.7 and 0.7) and this effect had disappeared after 72 hours. No iritis was observed.

Based on the mean (24, 48 and 72 hours) cornea opacity scores of 1.7 and 1.3 in two animals, classification for eye irritation is warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Cat. 2; H319). This classification translates into the classification according to EU Directive 67/548/EEC as Xi, R36 (Irritating to eyes).

Justification for classification or non-classification

For eye irritation, classification is warranted according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Cat. 2; H319). Classification for skin irritation is not needed based on the available data.