Registration Dossier
Registration Dossier
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EC number: 206-277-6 | CAS number: 320-51-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
No internal genotoxicity studies were conducted with 5-Amino-2-chlorobenzotrifluoride.
Results of a genotoxicity studies with 5-Amino-2-chlorobenzotrifluoride were published in literature:
5-Amino-2-chlorobenzotrifluoride showed no DNA damaging activity in a Bacillus subtilis Rec-Assay (B. subtilis parental strain PB 1652 (trpC2 metB10 lys3) and repair deficient mutant PB 1791 (trpC2 metB10 recE4)) when tested at doses of 500, 1000 and 5000 µg/disk.
5-Amino-2-chlorobenzotrifluoride did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100) when tested at non toxic concentrations of 50, 100 and 500 µg/plate in the absence or presence of metabolic activation (S9 mix) by direct plate incorporation and by preincubation (only TA 100).
Moreover, 5-Amino-2-chlorobenzotrifluoride showed no potential to induce mitotic crossing-over (reciprocal recombination) or mitotic gene conversion (non reciprocal recombination) in a test with S. cerevisiae strain 6117 at a concentration of 125 µg/ml in the absence and presence of metabolic activation .
According to current guidelines the above discussed publication has some limitations (e.g. Ames-Test: only three instead of five concentrations tested , negative results were not verified in a second test and it was not explained why, no testingwas conductedwith S. typhimurium strain TA 102) but taken all results together there is no evidence of a mutagenic potential of 5 -Amino-2 -chlorobenzotrifluoridein vitro.
Short description of key information:
No internal genotoxicity studies were conducted with 5-Amino-2-chlorobenzotrifluoride.
Results of a genotoxicity study with 5-Amino-2-chlorobenzotrifluoride were found in the literature (May 2011):
Rec-Assay (Bacillus subtilis); dosages 500-5000 µg/disk: negative
(Mazza, G. et al. (1986); Il Farmaco Edizione Pratica v. 41, ISS 7, p. 215-225)
Bacterial reverse mutation assay (Ames test); dosages 50-500 µg/plate with and without S9 mix: negative
(Mazza, G. et al. (1986); Il Farmaco Edizione Pratica v. 41, ISS 7, p. 215-225)
Gene conversion and mitotic crossing-over (Saccharomyces cerevisiae); dosage 125 µg/ml with and without S9-mix: negative
(Mazza, G. et al. (1986); Il Farmaco Edizione Pratica v. 41, ISS 7, p. 215-225)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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