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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
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
Chemical structure
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