Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
publication
Title:
Study of artificial flavouring substances for mutagenicity in the Salmonella/microsome, Basc and micronucleus tests
Author:
Wild D, King MT, Gocke E & Eckhardt K
Year:
1983
Bibliographic source:
Food Chem Toxicol. 1983 Dec;21(6):707-19

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloctane-1,7-diol
EC Number:
203-517-1
EC Name:
3,7-dimethyloctane-1,7-diol
Cas Number:
107-74-4
Molecular formula:
C10H22O2
IUPAC Name:
3,7-dimethyloctane-1,7-diol
Test material form:
liquid

Test animals

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

Administration / exposure

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
Doses / concentrationsopen allclose all
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

Examinations

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).

Results and discussion

Test results
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.