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EC number: 603-094-7
CAS number: 125904-11-2
Bacterial reverse mutation:
Hargitai J (2010) was selected as the key study for this data
requirement as it is the most recent study, performed to up to date
guidelines and in compliance with GLP. The study was assigned a
reliability score of 1.
Jagannath D.R. (1982) was provided as a supporting study to Hargitai J
(2010), the methods employed in the study were similar to the current
OECD guidelines, however, the study did not use one of the additional
cross linking in recommended by the revised guideline. The study was
assigned a reliability score of 2. The results reported in the study
were in agreement with those reported in the key study.
Mammalian cell in vitro mutagenicity:
Yang LL (1987) was provided as the key study for this data requirement.
The study was performed to a method similar to OECD 476 and in
compliance with GLP. The study was considered reliable and assigned a
reliability score of 1.
Four chromosomal aberration studies, three studies by SanSebastian J.R.
(1987) (performed on different batches of the same cell line) and one
study by Putman DL (1987). SanSebastian JR (1987) was selected as the
key study for this data requirement. Three chromosomal aberration
studies (performed on different batches of DBS concurrently) was
performed to methods comparable to OECD guideline 473 and in compliance
with GLP. One study by Putman DL (1987) also conducted to OECD guideline
473 provided equivocal results.
Mammalian cell cytogenicity:
Curren RD (1987) was provided as the key study for this data
requirement, the study was performed to methods comparable to the OECD
guideline 482 and in compliance with GLP. The study was assigned a
reliability score of 1 and considered adequate to fulfil the endpoint.
Justification for selection of genetic toxicity endpoint
No single study was selected as the genetic toxicity of the substance is
assessed using different studies that address different modes of action
and effects and are therefore not comparable.
Short description of key information:
The test substance Great Lakes DBS was tested for potential mutagenic
activity using the Bacterial Reverse Mutation Assay. The experiments
were carried out using histidine-requiring auxotroph strains of
Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and
TA1537), and the tryptophan-requiring auxotroph strain of Escherichia
coli (Escherichia coli WP2 uvrA) in the presence and absence of a
metabolic activation system (S9 fraction). The study included a
Preliminary Solubility Test, a Preliminary Range Finding Test
(Informatory Toxicity Test), an Initial Mutation Test, a Confirmatory
Mutation Test and a Complementary Confirmatory Mutation Test. In the
Range Finding Test as well as in the Initial Mutation Test, the plate
incorporation method was used. In the Confirmatory Mutation Test and
Complementary Confirmatory Mutation Test, the pre-incubation method was
used. The test substance was found to be non mutagenic under the test
conditions used in the study.
In a gene mutation in mammalian cells test, dibromostyrene was tested in
the CHO/HGPRT mutation assay at dose levels of 5, 10, 15, 20 and 25
nL/mL in the absence of S9 metabolic activation, and at 25, 40, 55, 60
and 70 nL/mL in the presence of S9 metabolic activation. The test
substance was negative, both in the absence and presence of metabolic
activation, in this CHO/HGPRT assay.
In an in-vitro unscheduled DNA synthesis, primary hepatocytes cultures
were set up from liver of male Sprague-Dawley rats. The top dose of 0.1
µg/mL had a relative toxicity (RT) of 59% and was toxic upon microscopic
examination. This dose could not be further evaluated. At the next lower
dose of 0.03 µg/mL had a RT of 14% and was also quite toxic, with nuclei
somewhat reduced in size, but could be evaluated for unscheduled DNA
synthesis. None of the test substance doses caused a significant
increase in the mean net grain counts. Dibromostyrene was negative under
the conditions of the study.
Endpoint Conclusion: No adverse effect observed (negative)
According to the criteria in directive 67/548/EEC
and regulation (EC) No 1272/2008, the substance does not meet the
criteria for classification concerning mutagenicity as the substance
proved to be negative in all the studies provided.
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