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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
publication
Title:
Structural specificity of aromatic compounds with special reference to mutagenic activity in Salmonella typhimurium-a series of chloro- or fluoro-nitrobenzene derivatives.
Author:
Shimizu M, Yasui Y & Matsumoto N
Year:
1983
Bibliographic source:
Mutat. Res. 116:217 - 238

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Rats were injected with PCB instead of Aroclor 1254. The S. thyphimurium strains, TA98, TA1538, TA1537, TA100 and TA 1535 were used instead of TA1535, TA1537 (or TA97a or TA97), TA98, and TA100 , and E.coli WP2 strains or S. typhimurium TA102.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): chlorobenzene
- Analytical purity: purity 98 %

Method

Target gene:
His+ revertants/plate
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix of rat liver pretreated with PCB
Test concentrations with justification for top dose:
0.02, 0.04, 0.08, 0.16, 0.32, 0.64 or 1.28 ul/plate in DMSO
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
0.05 ml of DMSO
True negative controls:
not specified
Remarks:
not examined
Positive controls:
yes
Positive control substance:
other: N-Ethyl-N´nitro-nitrosoguanidine (ENNG), 2-nitrofluorene (2-NF), 9 aminoacridine (9-AA) and 2-aminoanthracene (2-AA) (S9 mix added only).
Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Preincubation period: 15 minutes
- Exposure duration: 3 days


SELECTION AGENT (mutation assays): his+


NUMBER OF REPLICATIONS: All tests were performed in duplicated and repeated at least 3 times separately.


NUMBER OF CELLS EVALUATED: 3-6 X10000000


Evaluation criteria:
First, the tests were carried out without metabolic activation and were terminated if mutagenicity was observed. But if the results were negative, tests with metabolic activation were carried out additionally.
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: TA98, TA1538, TA1537, TA 100, TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
At 1.28 ul/plate of chlorobenzene toxic effect are observed.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: TA98, TA1538, TA1537, TA 100, TA 1535
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

Shimuzu et al., 1983.

The mutagenicity of chlorobenzene in Salmonella typhimurium (strains TA98, TA 1538, TA 1537, TA 100 and TA 1535) was examinated according to OECD TG 471 in the presence and in the absence of a metabolic activation system. 3 strains, TA98, TA 1538, and TA 1537, were used for detection of mutagens that cause frameshift mutations. TA 100 and TA 1535 were used for detection of mutagens causing base-pair mutations. Chlorobenzene was tested at the following concentrations 0.02 µl to 1.28 µl per plate. Solvent control served as negative control and positive controls are available. Cytotoxicity determined was observed at 1.28 µL/plate of chlorobenzene.

In this study chlorobenzene have been reported to be non-mutagenic in Salmonella typhimurium.