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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: 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

Constituent 1
Chemical structure
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.