Toluene

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: GLP status not known, near guideline study, published in peer reviewed literature, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

TA102 not used

Principles of method if other than guideline:

Liquid preincubation protocol using Salmonella strains TA89, TA100, TA1535 and TA1537 in the absence or presence of liver S9 from male Sprague-Dawley rats and Syrian hamsters induced with Aroclor 1254.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Toluene

EC Number:

203-625-9

EC Name:

Toluene

Cas Number:

108-88-3

Molecular formula:

C7H8

IUPAC Name:

toluene

Details on test material:

Chemical source: Fisher
Lot number: 782825
Label purity: Purified

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

rat or hamster liver S-9, Aroclor 1254 induced

Test concentrations with justification for top dose:

0, 10.0, 33.3, 100.0, 333.3, 1000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, 4-nitro-o-phenylenediamine, sodium azide, 9-aminoacridine

Remarks:

Positive and negative controls tested as coded samples

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: Three plates were used and the experiment was repeated at least 1 week after completion of the initial test.

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

Initially data were evaluated in an ad hoc manner. A positive response was indicated by a reproducible, dose-related increase, whether or not it was two fold over background.

Statistics:

The data were evaluated using an analysis based on models presented by Margolin et al, 1981 (methods not described).

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 / choice of top concentrations:

cytotoxicity

Remarks:

1000 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

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

Negative with and without metabolic activation

Executive summary:

Toluene was not genotoxic when tested with and without Aroclor 1254 metabolic activation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 at concentrations up to 1000 µg/plate (limit of cytotoxicity) using a liquid preincubation procedure.