Registration Dossier
Registration Dossier
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EC number: 252-240-2 | CAS number: 34840-23-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
BCI was initially screened with one plate per dose using the Salmonella/microsome plate incorporation test for point mutagenic effects in doses of up to and including 5000 ug per plate on 5 Salmonella typhi. LT2 mutants. These comprised the histidine-auxotrophic strains TA1535, TA100, TA1537, TA98 and TA102. The indipendent repeat was performed as preincubation for 20 minutes at 37°C. Other conditions remained unchanged.
Doses up to and including 500 ug per plate did not cause any bacteriotoxic effects: total bacteria counts remained unchanged and no inhibition of growth was observed.
At higher doses, the substance had only a weak, strain-specific bacteriotoxic effect. Due to the weakness of this effect this range could nevertheless be used for assessment purposes.
Evidence of mutagenic activity of BCI was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.
The positive controls sodium azide, nitrofurantoin, 4 -nitro-1,2 -phenylene diamine, cumene hydroperoxide and 2 -aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
Justification for selection of genetic toxicity endpoint
One available study
Short description of key information:
The Ames study was not conducted in compliance with the OECD principles and with the Principles of Good Laboratoy Practice according to Annex 1 German Chemicals Act .
The mutagenicity screening was performed using the Salmonella/microsome test as described by Ames et al. (1973a, 1975) and Maron and Ames (1983).
Testing facility: Bayer Industry Services, Leverkusen
Study no. T4069928 performed on April 24, 2001.
The registrant has a Letter of Access.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
BCI was considered to be non-mutagenic without and with S9 mix in the plate incorportation as well as in the preincubation screening.
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