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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Salmonella mutagenicity tests: V Results from the testing of 311 chemicals.
Author:
Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., Mortelmans, K.
Year:
1992
Bibliographic source:
Environ. Molec. Mutagen. 19, Suppl 21, 2-141

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chlorobenzoic acid
EC Number:
200-805-9
EC Name:
4-chlorobenzoic acid
Cas Number:
74-11-3
Molecular formula:
C7H5ClO2
IUPAC Name:
4-chlorobenzoic acid
Details on test material:
measured purity: 98%

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 97
Metabolic activation:
with and without
Metabolic activation system:
The S-9 (9,000 x g supernatant) fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared as described previously. The S-9 mixes were prepared immediately prior to use and contained either 10% or 30%
S-9; occasionally, 5% S-9 was also used. The specific S-9 concentrations used are indicated in tables. All chemicals were tested in the absence of metabolic activation, and with rat and hamster S-9 fractions.
Test concentrations with justification for top dose:
0, 10, 33, 100, 333, 1000, 3333, 5000, 6666 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Positive controls:
yes

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified

Applicant's summary and conclusion

Conclusions:
4-Chlorobenzoic acid was not mutagenic in a bacterial reverse mutation test.
Executive summary:

311 chemicals were tested for mutagenicity in Salmonella typhimurium. The tests were conducted using a preincubation protocol in the absence of exogenous metabolic activation, and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters.

4-Chlorobenzoic acid was not mutagenic under these test conditions.