3-chloroaniline

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

3-chloroaniline

EC Number:

203-581-0

EC Name:

3-chloroaniline

Cas Number:

108-42-9

Molecular formula:

C6H6ClN

IUPAC Name:

3-chloroaniline

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 / cell type:

S. typhimurium, other: (TA97), TA98, TA100, TA1535, TA1537

Details on mammalian cell type (if applicable):

no data

Additional strain / cell type 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

Untreated negative controls:

yes

Negative solvent / vehicle 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 / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: (TA97), TA98, TA100, TA1535, TA1537

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.