Reaction mass of (2-methoxymethylethoxy)propanol and [2-(2-methoxymethylethoxy)methylethoxy]propanol and sodium methanolate

Genetic toxicity: in vitro

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

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.