Registration Dossier

Diss Factsheets

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:

In the only dermal sensitization study conducted, dermal exposure to BTMAC did not result in a SI >3.0 (highest value at 25% concentration was 1.32) and thus it is considered negative for dermal sensitization potential in the LLNA.

Migrated from Short description of key information:
As a stimulation index (SI) of greater than 3.0 was not observed, Benzyltrimethylammonium Chloride (BTMAC) was considered negative for dermal sensitization potential in the LLNA at concentrations of less than or equal to 25%. Proper conduct of the LLNA was confirmed via a positive response with 25% HCA, a moderate contact sensitizer.

Justification for selection of skin sensitisation endpoint:
BTMAC did not elicit a positive response in LLNA.

Justification for classification or non-classification

No classification is necessary since BTMAC was negative in the LLNA and thus is not considered to be a dermal sensitizer.