Registration Dossier

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)

Data source

Reference
Reference Type:
secondary source
Title:
No information
Author:
National Library of Medicine HSDB Database
Year:
1987
Bibliographic source:
Zeiger E et al; Environ Mutagen 9: 1-110 (1987) **PEER REVIEWED**

Materials and methods

Principles of method if other than guideline:
Salmonella/microsome preincubation assay using the standard protocol approved by the National Toxicology Program.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat or hamster liver S9
Test concentrations with justification for top dose:
0, 10,
33, 100, 333, 1000, and 3333 ug/plate

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at 333 ug/plate
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

m-Chloroaniline was evaluated for mutagenicity in the Salmonella/microsome preincubation assay using the standard protocol approved by the National Toxicology Program. m-Chloroaniline was tested over a wide range of doses of 0, 10, 33, 100, 333, 1000, and 3333 ug/plate in four Salmonella typhimurium strains (TA98, TA100, TA1535, and TA1537) in the presence and absence of Aroclor-induced rat or hamster liver S9.
m-Chloroaniline was negative in these tests and the highest ineffective dose level tested in any Salmonella tester strain was 3333 ug/plate. This dose level was toxic to most strains under all conditions.