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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:
Not documented
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity of alkyl glycidyl ethers in three short-term assays
Author:
Thompson, E.D. et al.
Year:
1981
Bibliographic source:
Mutat. Res. 90, 213-231 (1981)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other. Bacterial reverse mutation conducted according to method of Ames
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: other TS - alkyl glycidyl ethers
Purity: 97.7 %, free from epichlorohydrin

Method

Target gene:
Not documented
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
No information provided
Test concentrations with justification for top dose:
20.6/ 61.7/ 185.2/ 555.5/ 1667/ 5000 ug/plate
Vehicle / solvent:
Not documented
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
Type: Ames test - bacterial test system - various strains of S.typhimurium
Evaluation criteria:
Not documented
Statistics:
Not documented

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No additional information provided
Remarks on result:
other: other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Both with/ without activation, dose-dependent increase in mutation frequency of TA 100 and TA 1535,

no increase with TA 98 and TA 1537, and TA 1538.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with and without metabolic activation

In this bacterial reverse mutation assay with and without metabolic activation glycidol showed positive results.
Executive summary:

In the study conducted by Thompson (1981), the test material, alkyl glycidyl ethers, were examined for their ability to cause genetic mutations when tested in strains of Salmonella typhimurium, specifically TA 98, TA 100, TA 1535, TA 1537 and TA 1538, in the presence and absence of metabolic activation. The test substance was tested at concentrations of 20.6, 61.7, 185.2, 555.5, 1667 and 5000 ug/plate. Based on the results of this study, the test substance induced a positive result when tested with and without metabolic activation.

Under the conditions of the study and based on the results, the test substance should be considered to be a genotoxicity Category 2 mutagen and should have the signal word Warning and the hazard statement H341: Suspected of causing genetic defects, in accordance with Regulation EC No. 1272/2008. According to Directive 67/548/EEC, the test substance should be classified as a Category 3 mutagen and should have the xymbol Xn and the risk phrase R68 Possible risk of irreversible effects associated with it.