Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-061-8 | CAS number: 77-83-8
Genetic toxicity: in vivo
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:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- EC Number:
- 201-061-8
- EC Name:
- Ethyl 2,3-epoxy-3-phenylbutyrate
- Cas Number:
- 77-83-8
- Molecular formula:
- C₁₂H₁₄O₃
- IUPAC Name:
- ethyl 3-methyl-3-phenyloxirane-2-carboxylate
- 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
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system 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
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
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 : 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
