A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The skin sensitising potential of the test article was assessed in a study conducted according to OECD guideline 406 (1981, GPMT, Ciba-Geigy Ltd 1984f). Induction was performed intradermally (1% in sesame oil) and one week later epicutaneously (10% in Vaseline, 48 h, occlusive). Two weeks after epidermal induction animals were challenged epicutaneously for 24 h with 1% test substance in Vaseline and Vaseline alone under semi-occlusive conditions. Under the experimental conditions employed, 70% (14/20) and 50% (10/20) of animals exhibited a positive skin reaction 24 and 48 hours after challenge, respectively.

Criteria for inclusion in GHS category 1A are a positive response in the GPMT in more than 60% of the guinea pigs at an intradermal induction dose of <= 1% .

Migrated from Short description of key information:
A valid study on skin sensitization with the test substance is available. In a study conducted according to OECD guideline 406 (GPMT) a positive skin reaction was observed in 14/20 animals after 24 h (guinea pig, Ciba-Geigy Ltd 1984f) and 10/20 animals after 48 h.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance was classified for skin sensitization (Xi; R43) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC

(Annex I index no. 607 -176 -00 -3).

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. More than 60% of the animals showed a resonse at an intradermal induction dose of 1%. As a result the substance is considered to be classified for skin sensitization in Category 1A under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).

At the time the substance was included in table 3.1 of Annex VI (EC 1272/2008) no distinction was made between category 1A and 1B. The legal classification (Annex I index no. 607 -176 -00 -3)

is Skin Category 1 (H317).