2,3-epoxypropan-1-ol

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

Study period:

Not documented

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

alkyl glycidyl ethers

IUPAC Name:

alkyl glycidyl ethers

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.