Registration Dossier
Registration Dossier
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EC number: 202-589-1 | CAS number: 97-53-0
Genetic toxicity: in vivo
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:
- 1 989
- 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
- Reference substance name:
- Eugenol
- EC Number:
- 202-589-1
- EC Name:
- Eugenol
- Cas Number:
- 97-53-0
- Molecular formula:
- C10H12O2
- IUPAC Name:
- 2-methoxy-4-(prop-2-en-1-yl)phenol
- Details on test material:
- - Name of test material (as cited in study report): Eugenol
(Further details were not reported.)
Constituent 1
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.
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