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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Schmid W (1976) The micronucleus test for cytogenetic analysis. In Chemical Mutagens. Edited by Hollaender A. Vol. 4. p 31. Plenum Press, New York.
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ethyl 3-methyl-3-phenylglycidate; EMPG; strawberry aldehyde
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 10 wk to 14 wk
- Weight at study initiation: No data
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle used: olive oil
- Justification for choice of solvent/vehicle:
- Concentration of test material in vehicle:
- Amount of vehicle (if gavage or dermal):
Duration of treatment / exposure:
30 hr
Frequency of treatment:
Treated only once
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
1856 mg/kg bw
Basis:
no data
Remarks:
Doses / Concentrations:
1237 mg/kg bw
Basis:
no data
Remarks:
Doses / Concentrations:
619 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
4
Control animals:
yes
Positive control(s):
No data

Examinations

Tissues and cell types examined:
Bone marrow
Details of tissue and slide preparation:
DETAILS OF SLIDE PREPARATION:
- Mice were killed and bone marrow smears were prepared 30 hr after treatment.
- The smears were stained according to the method of Schmid (1976).
Statistics:
Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970) Tables for determining the statistical significance of mutation frequencies. Mutation Research 9: 527

Results and discussion

Any other information on results incl. tables

Results on mouse bone marrow:

Dose (mg/kg body weight) Surviving:treated mice Mean No. of micronucleated polychromatic erythrocytes (PE)/1000 PE
1856 4:4 1.7
1237 4:4 1.7
619 4:4 1.3
0 (control) 4:4 1.9

No significant difference between the control and treated groups.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Wild et al. found that the test material was not genotoxic up to a concentration of 1856 mg/kg body weight in a mouse micronucleus test.