(Z)-2-butene-1,4-diol

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: 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

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

But-2-ene-1,4-diol

EC Number:

203-787-0

EC Name:

But-2-ene-1,4-diol

Cas Number:

110-64-5

Molecular formula:

C4H8O2

IUPAC Name:

2-Butene-1,4-diol

Constituent 2

Reference substance name:

(Z)-2-butene-1,4-diol

EC Number:

228-085-1

EC Name:

(Z)-2-butene-1,4-diol

Cas Number:

6117-80-2

Molecular formula:

C4H8O2

IUPAC Name:

but-2-ene-1,4-diol

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