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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
Study period:
1989-01-19 to 1989-03-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. Only four bacterial strains tested (S. typh. TA98, TA100, TA 1535, TA1537). No GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1988
Deviations:
no
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colourless liquid

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:
Aroclor 1254-induced rat liver S-9 mix
Test concentrations with justification for top dose:
0; 20; 100, 500; 2500; 5000 µg/plate
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene (2-AA)
Remarks:
with S-9 mix; TA98, TA100,TA1535, TA1537
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
Remarks:
without S-9 mix; TA100, TA1535
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylenediamine
Remarks:
without S-9 mix; TA98
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S-9 mix; TA1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: Standard plate test
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates per dose and control

METHOD OF APPLICATION: Preincubation test
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates per dose and control

DETERMINATION OF CYTOTOXICITY
- Method: background growth
Evaluation criteria:
In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results .
Statistics:
NA

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:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
The slight but not dose-dependent increase in the number of his+ revertants using TA 1537 in the 1st experiment could not be confirmed either in a additional standard plate test or in a preincubation assay; therefore the findings of this 1st experiment must be regarded as incidental.
Toxicity: No bacteriotoxic effect (reduced his- background growth) was observed.
Solubility: Complete solubility of test substance in DMSO.
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