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:

A contact hypersensitivity study was conducted in albino guinea pigs, (Maximization-Test, OECD 406) in compliance with GLP with FAT 41030 a structural analogue of FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, the use of this study for read-across is considered to be appropriate, thus avoiding a duplicate in vivo test with vertebrate animals.

 

This in vivo adjuvant sensitization test, comprised 15 (10 test and 5 control) male albino guinea pigs and was conducted to assess the cutaneous allergenic potential of FAT 41030. No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred. None of the control and test animals showed skin reactions after the challenge treatment with FAT 41030 at 25 % (w/w) in PEG 300.

 

Data on respiratory sensitisation are unavailable.


Migrated from Short description of key information:
Based on the results given in this study, test item failed to cause skin sensitization in the guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

FAT 41045 is not subject to classification according to the CLP (Reg. 1272/2008) or DSD (Dir. 67/548/EEC) regulations regarding skin or respiratory sensitisation, as the challenge treatment of guinea pigs with FAT 41030 in a skin sensitisation study (Maximisation test to OECD 406) did not elicit any skin reactions and data on respiratory sensitisation are unavailable.