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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
January 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acute oral toxicity was determined according to OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxyoxolan-2-one
EC Number:
692-561-9
Cas Number:
19444-84-9
Molecular formula:
C4H6O3
IUPAC Name:
3-hydroxyoxolan-2-one

Method

Target gene:
Target gene S.Typhimurium
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
Induced enzymatic systems contained in rat liver post-mitochondrial fraction (S9 fraction)
Test concentrations with justification for top dose:
The selected dose-levels for both mutagenicity experiments were 312.5, 625, 1250, 2500 and 5000 µg/plate, either with or without S9 mix.
Vehicle / solvent:
Water
Controls
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
mitomycin C
other: 2-Anthramine and Benzo(a)pyrene

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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

Under the experimental conditions of this study, the test item, 2-Hydroxy Gamma Butyro Lactone, did not show any mutagenic activity in the bacterialreverse mutation test with Salmonella typhimurium, in the absence or in the presence of a rat metabolising system.