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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 a test material was investigated by means of the Magnusson-Kligman Maximisation Test in guinea pigs. Induction with the test material was at concentrations of 2% (injection) and 75% (topical) w/v in distilled water. Challenge was at a concentration of 75% w/v in distilled water. At challenge, none of the test or control group animals treated with the test material at a concentration of 75% w/v in distilled water showed a positive response. There is no evidence from the test results that the test material is a sensitiser in guinea pigs.


Migrated from Short description of key information:
Not sensitising, female guinea pig, OECD 406, EU Method B.6, Cuthbert et al. 1993

Justification for selection of skin sensitisation endpoint:
The key study (Cuthbert, 1993) was performed according to GLP and the standardised guidelines OECD 406 and EU Method B.6. The study was therefore assigned a reliability score of 1 according to the principles for assessing data quality according to Klimisch (1997).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the 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 sensitizer.