Registration Dossier
Registration Dossier
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EC number: 204-602-6 | CAS number: 123-11-5
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: publication with limited documentation; no GLP; TS purity not specified;
Data source
Reference
- Reference Type:
- publication
- Title:
- STUDY OF ARTIFICIAL FLAVOURING SUBSTANCES FOR MUTAGENICITY IN THE SALMONELLA/MICROSOME, BASC AND MICRONUCLEUS TESTS
- Author:
- D.WILD; M.-T. KING; E . GOCKE and K. ECKHARDT
- Year:
- 1 983
- Bibliographic source:
- Fd Chem. Toxic.; Vol 21 , No 6, pp. 707-719
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- limited documentation
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4-ethoxybenzaldehyde
- EC Number:
- 233-093-3
- EC Name:
- 4-ethoxybenzaldehyde
- Cas Number:
- 10031-82-0
- Molecular formula:
- C9H10O2
- IUPAC Name:
- 4-ethoxybenzaldehyde
- Details on test material:
- - Name of test material (as cited in study report): 4-Ethoxybenzaldehyde
No further data.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system 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 hours
- Frequency of treatment:
- 2 applications (0, 24hours)
- Post exposure period:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
335; 670; 1005 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 4 (sex not specified)
- Control animals:
- yes
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- No details given
- Evaluation criteria:
- No details given
- Statistics:
- No details given
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Any other information on results incl. tables
Results of micronucleus test on mouse bone marrow
| Dose [mg/kg bw] | Surviving/treated mice | Mean no. of MNPE / 1000 PE |
| 1005 | 2/4 | 2.9 |
| 670 | 4/4 | 1.8 |
| 335 | 4/4 | 2.0 |
| 0 | 4/4 | 1.9 |
Applicant's summary and conclusion
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