Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a fully compliant Buhler assay, induction exposures were performed using the substance at 10% (first epidermal induction) and 5% in mineral oil (second and third induction). For challenge a concentration of 2.5% in mineral oil was used while re-challenge was performed using 2.5% and 1% concentrations. Clear evidence that skin sensitisation has occurred was obtained at challenge, where 19 and 17 out of the 20 treated animals showed dermal reactions of degree 1 after 24 and 48 hrs, respectively, and at re-challenge at 1%, where 14 and 12 out of the 20 treated animals showed skin reactions of degree 1 or 2 after 24 or 48 hrs, respectively. Dermal reactions in naïve control animals were always limited to degrees 0 or +/-.

Migrated from Short description of key information:
The following information is available for the sensitisation endpoint:

Rodabaugh D.D. (2008e) A sensitization study of AS305BD administered by the dermal route to Guinea pigs •Modified Buehler design•. Testing laboratory: Charles River Laboratories, Preclinical Services. Report no.: LMT00072. Owner company: Chevron. Report date: 2008-02-20.

This study has been rated as 1 under the Klimisch scoring system and so is considered to be sufficient to address this endpoint.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available.

Justification for classification or non-classification

The substance is a skin sensitizer and requires labelling with R43 – May cause sensitisation by skin contact. A

ccording to the GHS, the substance is assigned to skin sensitisation Category 1 (H317) and requires the signs of warning.