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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No information is available about GLP, study was conducted equivalent to OECD guideline 476.

Data source

Reference
Reference Type:
publication
Title:
Genotoxic and/or epigenetic effects of some glycol ethers: results of different short-term tests
Author:
Elias, Z. et al. (1996)
Year:
1996
Bibliographic source:
published in Occupational Hygiene, 2: 187-212 (1996).

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-propylene glycol 1-methyl ether
- Molecular formula (if other than submission substance): C5H13O2
- Molecular weight (if other than submission substance): 90.12
- Isomers composition: 1.2% beta isomer.
- Purity test date: 98.1% purity, 1.2% beta isomer.

Method

Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
- Type and identity of media: DMEM supplemented with 10% fetal calf serum (FCS) ans 2 rnM L-glutamine without antibiotics or fungistatics.
- Properly maintained: yes
Metabolic activation:
without
Test concentrations with justification for top dose:
14-55 mM
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMEM medium
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Evaluation criteria:
There are several criteria for determining a positive result, such as a concentration-related, or a reproducible increase in mutant frequency. Biological relevance of the results should be considered first. Statistical methods may be used as an aid in evaluating the test results. Statistical significance should not be the only determining factor for a positive response. A test substance, for which the results do not meet the above criteria is considered nonmutagenic in this system. Although most studies will give clearly positive or negative results, in rare cases the data set will preclude making a definite judgement about the activity of the test substance. Results may remain equivocal or questionable regardless of the number of times the experiment is repeated.
Positive results for an in vitro mammalian cell gene mutation test indicate that the test substance induces gene mutations in the cultured mammalian cells used. A positive concentrationresponse that is reproducible is most meaningful. Negative results indicate that, under the test conditions, the test substance does not induce gene mutations in the cultured mammalian cells used.

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks:
not stated
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Propylene glycol methyl ether was not mutagenic under the conditions of this test.