Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP and only 4 animals used per dose level.

Data source

Reference
Reference Type:
publication
Title:
Negative Evidence In Vivo of DNA-Damaging, Mutagenic and Chromosomal Effects of Eugenol
Author:
Maura A, Pino A, Ricci R.
Year:
1989
Bibliographic source:
Mutation Research. 1989; 227:125-129.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
Non-GLP and only 4 animals used per dose level.
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Eugenol
EC Number:
202-589-1
EC Name:
Eugenol
Cas Number:
97-53-0
Molecular formula:
C10H12O2
IUPAC Name:
4-allyl-2-methoxyphenol
Details on test material:
- Name of test material (as cited in study report): Eugenol

(Further details were not reported.)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 100-120 g

(Further details were not reported.)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: Watery suspension
Duration of treatment / exposure:
Half the dose was administered at 30 hours and the remainder at 6 hours prior to sacrifice.
Frequency of treatment:
Half the dose was administered at 30 hours and the remainder at 6 hours prior to sacrifice.
Post exposure period:
Sacrifice was 6 hours following administration of second half of the dose.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
335 mg/kg bw
Basis:
actual ingested
Remarks:
Doses / Concentrations:
670 mg/kg bw
Basis:
actual ingested
Remarks:
Doses / Concentrations:
1340 mg/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
4/dose
Control animals:
yes
Positive control(s):
Triethylenemelamine
- Route of administration: Intraperitoneal injection
- Doses / concentrations: 1 mg/kg bw

Examinations

Tissues and cell types examined:
Polychromatic erythrocytes; 1000 PCE scored/animal
Details of tissue and slide preparation:
Details were not reported but based on standard method of Schmid (1975).
Evaluation criteria:
Not reported.
Statistics:
Chi-square test.

Results and discussion

Test results
Sex:
female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
other: - unclear if vehicle control or negative control was used.
Negative controls validity:
other: - unclear if vehicle control or negative control was used.
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The genotoxic potential of eugenol was assessed in a bone marrow micronucleus assay in rats. Eugenol was administered via the oral (gavage) route at doses of 335, 670, or 1,340 mg/kg as divided doses at 30 and 6 hours prior to harvesting of the bone marrow. Eugenol was negative in this micronucleus assay.
Executive summary:

The genotoxic potential of eugenol was assessed in a bone marrow micronucleus assay in rats. Eugenol was administered via the oral (gavage) route at doses of 335, 670, or 1,340 mg/kg as divided doses at 30 and 6 hours prior to harvesting of the bone marrow. Eugenol was negative in this micronucleus assay. In the REACH guidance r7a integrated testing strategy for mutagenicity, the in vivo micronucleus assay may be used to follow-up in vitro clastogenicity postive results. Therefore, this study may be used to fulfil the Annex VIII section 8.4.2 requirement for a gene mutation study in mammalian cells, which also states in column 2 that the in vitro study is not required if adequate data from an in vivo cytogenicity test are available.

Categories Display