3,7-dimethyloctane-1,7-diol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.

An in vitro gene mutation study in mammalian cells does not to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available.test substance.

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

up to 3600 µg/plate with and without S-9 mix
Positive controls: sodium azide and benzo[a]pyrene
Results that met the following additional criteria were regarded as positive: reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

Supplier: ICN, ICNK &K: Plainview, NY, USA

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

up to 3600 µg/plate

Vehicle / solvent:

DMSO

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

benzo(a)pyrene

Details on test system and experimental conditions:

not further specified

Evaluation criteria:

Results that met the following additional criteria were regarded as positive: reproducible, dose-related and at least two-fold elevation of the spontaneous revertant frequency

Statistics:

not further specified

Key result

Species / strain:

other: all strains tested

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Conclusions:

The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.

Executive summary:

The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.

Reference 2

Endpoint:

in vitro cytogenicity / micronucleus study

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

An in vitro gene mutation study in mammalian cells does not to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available.

Reference 3

Endpoint:

in vitro gene mutation study in mammalian cells

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

The micronucleus test on mouse bone marrow was performed to determine the mutagenic effects of the test substance. The test substance was tested at dose levels of 0, 516, 860 and 1204 mg/kg. The test substance failed to produce genetic effects in the micronucleus test on mouse bone marrow cells and is negative for gene mutation in vivo.

Link to relevant study records

Reference

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

not specified

Type of assay:

other: mammalian erythrocyte micronucleus test (migrated information)

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 - 14 weeks

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: olive oil

Duration of treatment / exposure:

30 h

Frequency of treatment:

1x

Post exposure period:

30 h

Dose / conc.:

516 mg/kg bw (total dose)

Dose / conc.:

860 mg/kg bw (total dose)

Dose / conc.:

1 204 mg/kg bw (total dose)

No. of animals per sex per dose:

4

Tissues and cell types examined:

polychromatic erythrocytes of bone marrow

Details of tissue and slide preparation:

The smears were stained according to the method of Schmid (Schmid W. 1976; Chemical Mutagens; edited by A . Hollaender; Vol4; p31; Plenum Press, New York). Slides were scored as described by Wild (Wild D. 1980; Archs Toxicol.; 43; 249).

Evaluation criteria:

No. of polychromatic erthrocytes

Statistics:

Statistical significance was determined according to the methods of Kastenbaum & Bowman (Kastenbaum M. 1970; Mutation Res. 9; 527).

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Remarks:

Mortality 3/7 animals at highest dose

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

not specified

DOSE: mean number of micronucleated polychromatic erythrocytes (PE) per 1000 PE

516 mg/kg bw: 2.2 (4/4 animals survived)

860 mg/kg bw: 2.2 (4/4 animals survived)

1204 mg/kg bw: 2.6 (3/7 animals survived)

vehicle control: 2.0 (4/4 animals survived)

mean of the vehicle controls for all substances tested: 1.85

Conclusions:

The substance was negative in an viivo micronucleus study in mice as it did not produce genetic effects on mouse bone marrow cells.

Executive summary:

The micronucleus test on mouse bone marrow was performed to determine the mutagenic effects of the test substance. The test substance was tested at dose levels of 0, 516, 860 and 1204 mg/Kg.

The test substance failed to produce genetic effects in the micronucleus test on mouse bone marrow cells and is negative for gene mutation in vivo.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

The test item gave no indication for a genotoxic potential in an Ames test performed on five tester strains of Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA1538 and TA98) both with and without S9 mix.

An in vitro gene mutation study in mammalian cells does not to be conducted because adequate data from a reliable in vivo mammalian gene mutation test are available.

The micronucleus test on mouse bone marrow was performed to determine the mutagenic effects of the test substance. The test substance was tested at dose levels of 0, 516, 860 and 1204 mg/kg. The test substance failed to produce genetic effects in the micronucleus test on mouse bone marrow cells and is negative for gene mutation in vivo.