4-chlorotoluene

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Principles of method if other than guideline:

Preincubation method according to Ames, Mutat. Res. 31, 347 (1975), Maron, Mutat. Res. 113, 173 (1983)
The test compound dissolved in 0.05 or 0.1 ml of solvent was supplemented with 0.5 ml of 59mix (metabolie activation method) or O.IM phosphate buffer pH7.4 (direct method) and 0.1 ml of tester strains whieh had been cultured in nutrient broth. The mixture was incubated for 20 min. at 37°C, then rapidly mixed with 2 ml of molten top agar containing 0.05µmol/ml of L-histidine and biotin for the Salmonella test. In the E. coli test 0.05/1 mol/
ml of L-tryptophan was used instead of L-histidine and biotin. Then the top agar mixture was rapidly poured onto a 30 ml of Vogel-Bonner minimal agar plate. All plates were incubated for 48 hours at 37°C and the numbers of revertant colonies were scored.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-chlorotoluene

EC Number:

203-397-0

EC Name:

4-chlorotoluene

Cas Number:

106-43-4

Molecular formula:

C7H7Cl

IUPAC Name:

4-chlorotoluene

Details on test material:

p-chlorotoluene, purity: 99 %

Method

Target gene:

no data

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA98, TA100, TA102, TA104, TA1535, TA1537, Escherichia coli WP2uvrA, WP2uvrA/pKM101

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

1) +/-S9: 0.0763, 0.305, 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate;
2) +/-S9: 2.44 (only S.typh strains -S9), 4.88 (only S.typh strains -S9), 9.77, 19.5, 39.1, 78.1, 156, 313, 625 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: without activation: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide, sodium azide, 9-aminoacridine, 2-nitrofluorene, 4-nitroquinoline-N-oxide, bleomycin, pyruvic aldehyde; with activation: 2-amino anthracene

Details on test system and experimental conditions:

IUCLID4 Type: Ames test

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA98, TA100, TA102, TA104, TA1535, TA1537, Escherichia coli WP2uvrA, WP2uvrA/pKM101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: from 313 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: Salmonella typhimurium TA98, TA100, TA102, TA104, TA1535, TA1537, Escherichia coli WP2uvrA, WP2uvrA/pKM101

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The positive controls were functional

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

method: an Ames test was conducted using a preincubation protocol in the absence of exogenous metabolic activation, and in the presence of liver S-9.

result: p-chlorotoluene was negative in the test with and without metabolic activation