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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

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 et al.
Year:
1983
Bibliographic source:
Food and Chemical Toxicology 21, 707– 719

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Supplier: ICN-K&K, Plainview, NY, USA
No further data given

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals 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:
once
Post exposure period:
30 h
Doses / concentrations
Remarks:
Doses / Concentrations:
345, 603, 861 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
4 animals per dose
Control animals:
yes, concurrent vehicle
Positive control(s):
no data

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).
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:
female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

Results expressed as mean number of micronucleated polychromatic erythrocytes (PE) per 1000 PE:

345 mg/kg bw: 1.5 (4/4 animals survived)

603 mg/kg bw: 1.0 (4/4 animals survived)

861 mg/kg bw: 2.0 (4/4 animals survived)

vehicle control: 1.5 (4/4 animals survived)

mean of the vehicle controls for all substances tested: 1.85

A structurally and metabolically related substance (Hydroxycitronellol CAS. 107-74-4)

was tested under similar testing conditions:

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