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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: Non-GLP guideline study

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)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Analytical purity: 97.5 %

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
20 - 5000 ug/plate (standard plate test) and (preincubation test)
Vehicle / solvent:
Distilled water
Controls
Untreated negative controls:
yes
Remarks:
Distilled water
Negative solvent / vehicle controls:
yes
Remarks:
Distilled water
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: See study details below
Evaluation criteria:
Doubling of the spontaneous mutation rate
Dose-response relationship
Reproducibility of the results
Statistics:
None

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:
other: Slight, <50% at 5000 mcg/plate with S9 in some strains using titer method, but no reduction in background bacterial lawns on test plates.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Any other information on results incl. tables

Toxicity:

Slight, <50% at 5000 mcg/plate with S9 in some strains using titer method, but no reduction in background bacterial lawns on test plates.

Mutagenicity:

An increase in the number of his+ revertants was not observed both in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system.

According to the result ot the present study, the test substance 2 -Buten-1,4 -diol is not mutagenic in the Ames test under the experimental conditions chosen here.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative