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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study follows general design of OECD 473

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Lot/batch No.:S44OTO6022
Physical state: liquid

Method

Species / strain
Species / strain / cell type:
hepatocytes: Rat liver (RL4) cells
Details on mammalian cell type (if applicable):
monolayer slide culture
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
not applicable
Test concentrations with justification for top dose:
5000, 2500, 1250, and 625 microgram/ml

Vehicle / solvent:
Water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
7,12-dimethylbenzanthracene
Evaluation criteria:
There are several criteria for determining a positive result, such as a concentration-related increase or a reproducible increase in the number of cells with chromosome aberrations. 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.

An increase in the number of polyploid cells may indicate that the test substance has the potential to inhibit mitotic processes and to induce numerical chromosome aberrations. An increase in the number of cells with endoreduplicated chromosomes may indicate that the test substance has the potential to inhibit cell cycle progression.

A test substance for which the results do not meet the above criteria is considered nonmutagenic in this system. Although most experiments will give clearly positive or negative results, in rare cases the data set will preclude making a definite judgment 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 from the in vitro chromosome aberration test indicate that the test substance induces structural chromosome aberrations in cultured mammalian somatic cells. Negative results indicate that, under the test conditions, the test substance does not induce chromosome aberrations in cultured mammalian somatic cells.

Results and discussion

Test results
Species / strain:
hepatocytes: Rat liver (RL4) cells
Metabolic activation:
not applicable
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Under the experimental conditions of this study dipropylene glycol methyl ether did not induce chromosome damage in rat liver cells.

Executive summary:

 

Dipropylene glycol methyl ether (DPM) was evaluated for chromosomal aberration test in rat liver cells. A maximum dose level of 5000 µg/ml DPM was determined as appropriate in the chromosomal aberration assay. 7,12-dimethylbenzanthracene was used as a positive control. There was no significant increase, beyond control limits, in the frequency of chromatid gaps, chromatid breaks or total chromatid aberrations in the rat liver cells exposed to DPM concentration up to 5000 µg/ml, indicating that the compound did not induce chromosome damage in rat liver cells.