Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The skin sensitisation potential of the test material was investigated following a methodology similar to standardised guidelines OECD 406 and EU Method B.6 using the guinea pig maximisation test. The procedure consisted of two induction treatments (an intradermal injection conducted on day 0 and a topical application scheduled on day 7) followed 14 days later by a challenge treatment (topical application). A concurrent control group was submitted to a similar regimen: induction treatments with the diluent followed by challenge treatment with the test material. A positive control group was also included to confirm validity of the test method employed. Under the conditions of the study neither the test material induced animals nor the test material control animals responded to challenge treatment. Therefore, no positive sensitisation reactions were observed for the test material and so the test material was considered to be unlikely to be a skin sensitiser. The positive control was shown to have the capacity to cause skin sensitisation confirming the validity of the protocol used for this study.


Migrated from Short description of key information:
Not sensitising, male guinea pig, OECD 406, EU Method B.6, Silveira and Wong (1982)

Justification for selection of skin sensitisation endpoint:
Only one study is available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material did not elicit a response in the guinea pig Maximisation test and therefore does not meet the criteria for classification as a skin sensitiser.