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EC number: 401-540-3 | CAS number: 84632-65-5
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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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP compliance was not stated in the report. The test conduct was in principle similar to the OECD 474 (1981). However, with following deviations: Mice or rats are recommended in the guideline; Chinese hamster were used in this study. Additionally, 1000 polychromatic erythrocytes/animal were scored for the incidence of micronuclei instead of 2000 as claimed in the guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Principles of method if other than guideline:
- Mice or rats are recommended in the guideline. Chinese hamster were used in this study. Additionally, 1000 polychromatic erythrocytes/animal were scored for the incidence of micronuclei instead of 2000 claimed in the guideline.
- GLP compliance:
- no
- Remarks:
- not stated in the report
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Purity: Commercial grade
- Lot/batch No.: Op. 11006
- Stability of test article: In the report it was stated that stability was guaranteed by the sponsor.
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: random outbred
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain as stated in the report: Chinese hamster (Cricetulus griseus), random outbred strain
- Source: CIBA-GEIGY LTD. Tierfarm, Sisseln, Switzerland
- Age at study initiation: 6 - 10 weeks (males), 4 - 9 weeks (females)
- Weight at study initiation: 20 - 28 g (females), 23 - 33 g (males)
- Housing: individually
- Diet (ad libitum): standard diet, NAFAG No. 924
- Water (ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23
- Humidity (%): 48 - 51
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle: 0.5 % aqueous solution of sodium carboxymethylcellulose (CMC)
- Concentration of test material in vehicle: 5000 mg/kg bw in 20 ml/kg bw - Duration of treatment / exposure:
- After single oral administration of 5000 mg/kg bw animals were observed for 16, 24 and 48 h.
- Frequency of treatment:
- Single oral administration.
- Post exposure period:
- 16, 24 and 48 h.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 16 animals (8 females, 8 males).
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- Animals treated with cyclophosphamide (64 mg/kg bw in 20 ml/kg bw 0.5 % CMC) served as positive control.
Examinations
- Tissues and cell types examined:
- Bone marrow was harvested from the shafts of both femurs. Normochromatic erythrocytes (NCE) as well as polychromatic erythrocytes (PCE) were counted for determination of the PCE/NCE-ratio. 1000 PCE per animal were used to determine the incidence of micronucleated PCE.
- Details of tissue and slide preparation:
- Bone marrow was harvested from the shafts of both femurs with a pipette and aspirated gently in 0.5 µl rat serum. Small drops of the mixture were transferred on a slide and spread out by pulling it behind a cover glass. The preparations were air-dried and stained in undiluted May-Grünwald solution (2 min) and subsequently in May-Grünwald solution/water 1/1 (2 min), followed by 20 minutes in 40 % Giemsa's. Following rinsing and washing with 55 % methanol and/or water, the slides were air-dried, cleared in Xylene and mounted in Eukitt.
- Statistics:
- The significance of difference was assessed by Chi square - test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- (Micronucleated PCE cells 0.18 % versus 0.13 % in negative control)
- Toxicity:
- no effects
- Remarks:
- (No significant difference in PCE/NCE-ratio between treated and negative control)
- Vehicle controls validity:
- valid
- Negative controls validity:
- other: see vehicle control
- Positive controls validity:
- valid
Any other information on results incl. tables
One female animal of the control group died during the experiment.
The percentage of micronucleated PCE was 0.13 % in the negative, 0.18 % in the treated group and 3.34 % in the positive control. As expected the positive control was statistically significantly different from negative control.
Applicant's summary and conclusion
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