Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.