Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

TK 12146, was tested in the chromosome aberration assay using Chinese hamster ovary (CHO) cells in both the absence and presence of an Aroclor-induced rat liver S9 metabolic activation system. The results indicate that Trichloro(N,N-dimethyloctylamine)boron (TK 12146) was negative in the in vitro chromosome aberration assay in CHO cells.

The test substance TK I 2146 was concluded to be negative in a Bacterial Reverse Mutation Assay.

The test substance, trichloro(N,N-dimethyloctylamine)boron (TK 12146) was evaluated for its ability to induce forward mutations at the hypoxanthineguanine phosphoribosyl transferase (HPRT) locus (hprt) of Chinese hamster ovary (CHO) cells, in the presence and absence of an exogenous metabolic activation system (S9), as assayed by colony growth in the presence of6-thioguanine (TG resistance, TG').

The results indicate that TK 12146 was negative in the In Vitro Mammalian Cell Forward Gene Mutation (CHO/HPRT) Assay with Duplicate Cultures.


Justification for selection of genetic toxicity endpoint
Three in vitro studies were performed, (Ames test using Salmonella typhimurium), chromosome aberration using Chinese Hamster Ovary cells and an in vitro mammalian cell forward gene mutation (HPRT/CHO) assay with duplicate cultures.
All these three studies are negative and all of them are taken into consideration

Short description of key information:
TK 12146 was concluded to be negative for the induction of structural and numerical chromosome aberrations in CHO cells in both the non-activated and the S9-activated test systems. The results of the Bacterial Reverse Mutation Assay in S. typhimurium indicate that TK 12146 did not cause a positive mutagenic response with any of the tester strains in either the presence or absence of Aroclor- induced rat liver S9.
TK 12146 was negative in the In Vitro Mammalian Cell Forward Gene Mutation (CHO/HPRT) Assay with Duplicate Cultures.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No.1272/2008) and DSD (Directive 67/548/EEC).