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 this approved study conducted under GLP, 5-ethylidene-norborn-2-ene was shown to be a sensitizer at 50% v/v and neat. The result suggest that ENB is a weak sensitiser.


Migrated from Short description of key information:
LLNA study: Positive (weak sensitiser)

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

Justification for classification or non-classification

The results from a mouse LLNA study indicate that ENB should be classified as a skin sensitiser. According to the classification criteria of regulation 286/2011, which amended regulation 1272/2008, an EC3 value of >2% would indicate classification as a weak sensitiser (category 1B). The quantitative data indicate that the response is very weak, with the EC3 value actually being >40%. According to the recommendations of ECETOC ("Contact Sensitisation: Classification according to potency", Technical Report 87, 2003) such a weak response would justify a classification limit for mixtures of 3% rather than the default of 1% and this is proposed for classification purposes.

There is no data on respiratory sensitisation.