Registration Dossier
Registration Dossier
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EC number: 222-023-7 | CAS number: 3320-83-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The test substance was initially investigated using the Salmonella/ microsome plate incorporation test for point mutagenic effects in doses of up to and including 5000 µg per plate on five Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537, TA 98 and TA 102.
Doses up to and including 500 µg 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 a strong, strain-specific bacteriotoxic effect, so that 1581 µg per plate could not be used for assessment purposes. 5000 µg per plate could not be used for assessment. Substances precipitation occurred at the dose 1581 µg per plate and above.
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.
Evidence of mutagenic activity of the test substance was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.
Additionally an independent repeat with doses up to 1200 µg per tube after preincubation for 20 minutes at 37°C on the same Salmonella typhimurium strains was evaluated. Doses up to and including 150 µg per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strong, strain-specific bacteriotoxic effect, so that 1200 µg per tube could only be used to a limited extent for assessment purposes.
Evidence of mutagenic activity of the test substance was not seen Herbold, 1996.
Short description of key information:
in vitro:
Ames test: negative
Cytogenetic assay: no data
mammalian cell gene mutation test: no data
in vivo:
no data
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification required.
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