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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: scientifically acceptable and sufficient documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
m-Chloroaniline were sent to the testing laboratories as coded aliquots and were incubated with the S. typhimurium tester strains TA97, TA98, TA100, TA1535, and TA1537 either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37°C. Top agar supplemented with L-histidine and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates. Histidine-independent mutant colonies arising on these plates were counted following incubation for 2 days at 37°C.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
m-chloroaniline, a pale yellow liquid, was identified by infrared spectroscopy; each spectrum was consistent with a literature reference (Aldrich Library of FT-IR Spectra, 1985) and with that expected for the chemical structure. Gas chromatography indicated a purity greater than 99%.
Boiling Point: 230.5°C
Density at 22°C: 1.210
Vapor pressure: <0.1 mmg Hg at 30°C
Solubility: practically insoluble in water, soluble in organic solvents

Method

Species / strain
Species / strain:
other: (TA97), TA98, TA100, TA1535, TA1537
Details on mammalian cell lines (if applicable):
no data
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9mix
Test concentrations with justification for top dose:
0, 10, 33, 100, 333, 1000 µg/plate (with strains TA98, TA100, TA1535, TA1537 - study performed at Case Western Reserve University)
0, 33, 100, 333, 1000, 1500, 2000 (with strains TA97, TA98, TA100, TA1535, TA1537 - study performed at Microbiological Assocoates, Inc.)
Controls
Negative controls:
yes
Solvent controls:
yes
True negative controls:
not specified
Positive controls:
yes

Results and discussion

Test results
Species / strain:
other: (TA97), TA98, TA100, TA1535, TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

m-chloroaniline (1 to 2,000 μg/plate) was tested with a preincubation protocol at two laboratories for mutagenicity in Salmonella typhimurium strains TA97, TA98, TA100, TA1535, and TA1537, with and without Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver S9; no mutagenic activity was observed.

Applicant's summary and conclusion

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

m-Chloroaniline was evaluated with the S. typhimurium tester strains TA97, TA98, TA100, TA1535, and TA1537 either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37°C. Top agar supplemented with L-histidine and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates. Histidine-independent mutant colonies arising on these plates were counted following incubation for 2 days at 37°C.

Each trial consisted of triplicate plates of concurrent positive and negative controls and of at least five doses of m-chloroaniline. The high dose was limited by toxicity.

m-chloroanilinewas negative in Salmonella typhimurium strains TA97, TA98, TA100, TA1535, and TA1537, with and without metabolic activation.