[(methylethylene)bis(oxy)]dipropanol

Genetic toxicity: in vitro

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: see 'Remark'

Remarks:

GLP-compliant, comparable to guideline study, available as unpublished report, minor restrictions in reporting, but otherwise adequate for assessment. Proof of the identity of the substance used in a study is the responsibility of the data owner of the study (internal company reference code 35109).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

GLP compliance:

yes (incl. QA statement)

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Oxydipropanol

EC Number:

246-770-3

EC Name:

Oxydipropanol

Cas Number:

25265-71-8

Molecular formula:

C6H14O3

IUPAC Name:

1,1-Oxydi-2-Propanol

Details on test material:

- Name of test material (as cited in study report): 02511.01
- Physical state: clear liquid
- Storage condition of test material: room temperature

Method

Target gene:

TK locus

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat S9

Test concentrations with justification for top dose:

In the range-finding test: 0.1, 0.5, 1.0, 5.0, 10, 50, 100, 500, 1000 and 5000 µg/ml
In the main test: 50, 100, 300, 500, 700, 1000, 2500 and 5000 µg/ml

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: F0P, Fischer's Medium for leukemic cells of mice, supplemented with sodium piruvate, Pluronic P68, and penicyllin-strepromycin according to the Standard Operating Procedures of the test facility
- Justification for choice of solvent/vehicle: solvent of preference by the study sponsor

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9: ethyl methanesulfonate, with S9: 7, 12-dimethylbens(a)anthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium;

DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): at least 15 min


SELECTION AGENT (mutation assays): trifluorothymidine (TFT)

NUMBER OF REPLICATIONS: two

NUMBER OF CELLS EVALUATED: 3 x 10e6

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

A response is considered positive if at least one culture has a mutation frequency that is two times or mroe greater than the average muitation frequency of the corresponding solvent control cultures and the response is dose-dependent. A response is considered equivocal if it does not fulfill the criteria of either a negative or a positive response, and/or the study director does not consider the response to be either positive or negative. A response is considered negative, if all of the cultures exhibiting total growth of 10% and greater have mutation frequencies that are less than twice that of the mean mutation frequencies of the corresponding solvent contol cultures, and there is no evidence of a dose-dependent response.

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

No toxicity was evident in any of the cultures in the range finding test. The culturres treated with 5000 µg/ml with and without S-9 had 93 and 98% relative suspension growth, respectively.
None of the cultures in the main test had mutation frequencies that were significantly greater than the mean mutation frequency of the solvent control cultures. The cultures treated without activation exhibited 88 to 104% relative total growth, and the cultures treated in conjunction with S9 exhibited 82 to101% relative total growth.
As expected, the cultures treated with the positive controls exhibited significant increases in mutation frequency relative to their solvent control cultures.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.