Registration Dossier
Registration Dossier
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EC number: 947-368-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
in vitro skin sensitization, reliability K1, WOE - DPRA - Inconclusive
in vitro skin sensitization, reliability K1, WOE - Keratinosens - Positive
in vivo (non-LLNA) OECD 406, reliability K2 (read-across from BPAF), WOE - Negative
in vivo (non-LLNA), reliability K2, (read-across from BTPPC), WOE - Negative
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Two in vitro studies were conducted on the substance BPAF/BPAF:BTPP-Salt: DPRA - Inconclusive and Keratinosens - Positive. One in vivo (non-LLNA) assay done on BTPPC (see WOE) resulted negative, supporting the non-classification of BPAF/BPAF:BTPP-Salt, for skin sensitization. An existing in vivo (non-LLNA) assay tested on BPAF resulted negative, supported the negative classification for skin sensitization.
The overall results from the available data allow the conclusion that BPAF/BPAF:BTPP-Salt is negative for skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There is whole animal skin sensitization testing for both BPAF and the salt BTPPC indicating that neither is a skin sensitiser. The reaction mass consists of both these moieties and is expected to return to BPAF and the BTPP ion in water. It is reasonable to conclude that the reaction mass is also not a skin sensitizer.
The overall results from the available data allow the conclusion that BPAF/BPAF:BTPP-Salt does not meet the classification criteria for skin sensitisation in accordance with Regulation (EC) No 1272/2008 (CLP).
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