Registration Dossier
Registration Dossier
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EC number: 200-533-0 | CAS number: 62-44-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Micronucleus induction in mouse bone marrow by phenacetin administered intraperitoneally or orally
- Author:
- N. Hachiya
- Year:
- 1 989
- Bibliographic source:
- Mutation Research, 223 (1989) 365-368 365, Elsevier
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Phenacetin
- EC Number:
- 200-533-0
- EC Name:
- Phenacetin
- Cas Number:
- 62-44-2
- Molecular formula:
- C10H13NO2
- IUPAC Name:
- phenacetin
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: MS/Ae
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: MS/A ( Charles River Japan, Inc.)
- Age at study initiation: 9 week old
- Diet (e.g. ad libitum): fed commercial pellets (not specified)
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 1 week or more
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Vehicle(s)/solvent(s) used: olive oil (henacetin was suspended homogeneously in the vehicle but could not be dissolved.)
- Concentration of test material in vehicle: was suspended in olive oil at concentrations of 1-500 mg/ml to make an injection volume of 10 ml/kg body weight for all doses
- Duration of treatment / exposure:
- 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 150 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 600 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 200 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 4 mice per group were used
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- none
Examinations
- Tissues and cell types examined:
- Micronucleated polychromatic erythrocytes (MNPCEs) in mouse bone marrow
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
Any other information on results incl. tables
Table 2. Micronucleus induction of phenacetin in MS/Ae and CD-1 mice 24h after administration
| Strain | Dose (mg/kg) | i.p (intraperitoneal injection) | p.o (gastric incubation) | ||||||
| survival | Number of PCEs observed | Frequency of PCEs (%±SD) | Frequency of MNPCEs (%±SD) | Survival | Number of PCEs observed | Frequency of PCEs (%±SD) | Frequency of MNPCEs (%±SD) | ||
| MS/Ae | 0 | 4/4 | 4000 | 35.4±3.7 | 0.53±0.10 | 4/4 | 4000 | 42.1±4.5 | 0.40±0.24 |
| 150 | 4/4 | 4000 | 30.4±12.4 | 0.35±0.31 | 4/4 | 4000 | 41.1±9.0 | 0.48±0.10 | |
| 300 | 4/4 | 4000 | 34.4±4.2 | 0.55±0.13 | 4/4 | 4000 | 37.5±1.4 | 0.33±0.25 | |
| 600 | 4/4 | 4000 | 36.2±6.3 | 1.18±0.56 | 4/4 | 4000 | 37.1±8.2 | 1.30±0.52** | |
| 1200 | 0/4 | 0 | 3/4 | 3000 | 18.4±5.9 | 0.43±0.35 | |||
| CD-1 | 0 | 4/4 | 4000 | 47.3±5.0 | 0.08±0.10 | 4/4 | 4000 | 45.6±5.2 | 0.15±0.13 |
| 150 | 4/4 | 4000 | 51.8±3.8 | 0.15±0.17 | 4/4 | 4000 | 44.6±3.1 | 0.08±0.10 | |
| 300 | 4/4 | 4000 | 57.2±1.2 | 0.25±0.13 | 4/4 | 4000 | 55.2±4.4 | 0.15±0.13 | |
| 600 | 4/4 | 4000 | 43.5±4.1 | 0.45±0.52 | 4/4 | 4000 | 50.8±2.4 | 0.43±0.10 | |
| 1200 | 3/4 | 3000 | 44.5±6.5 | 1.53±0.92 | 4/4 | 4000 | 44.2±5.2 | 1.75±0.33 | |
Applicant's summary and conclusion
- Conclusions:
- Test item was positive in micronucleus induction by intraperitoneal route of administration in MS/Ae mouse strain.
- Executive summary:
In a micronucleus test conducted, test item was administered intraperitoneal to MS/Ae mouse strain (male). Administration doses were 0 (vehicle), 150, 300, 600 amd 1200 (mg/kg). The frequency of MNPCEs increased at doses up to 1200 mg/kg.
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