Registration Dossier

Diss Factsheets

Administrative data

Description of key information

not sensitizing

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitizing potential of the test material (purity 94.6%) was examined in a GLP compliant study (Ciba/RCC 267164 (1990)) according to OECD guideline 406 (1983). Five male and five female Himalayan guinea pigs were used in the control group and ten male and ten female animals were used in the test group. For intradermal injections of the test group, 0.1 mL of a 3% solution in PBS, Freund’s complete adjuvant (50:50) or 3% in Freud’s adjuvant was used. For challenge one week later, the highest non-irritating dose of 10% was used. One day after challenge, 2/20 showed a positive reaction for erythema compared to 0/10 in the control group. After two days, 1/20 animals showed a positive reaction compared to 0/10 in the control group. From the results of this study no allergenic potency of the test article was concluded.

Migrated from Short description of key information:

The test substance is not a skin sensitizer

Justification for classification or non-classification

Based on the results of the guinea pig maximization test, the test substance needs not to be classified as sensitising to the skin according to Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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