Registration Dossier
Registration Dossier
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EC number: 212-714-1 | CAS number: 853-23-6
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study initiated in April 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Prasterone
- EC Number:
- 200-175-5
- EC Name:
- Prasterone
- Cas Number:
- 53-43-0
- Molecular formula:
- C19H28O2
- IUPAC Name:
- (3S,8R,9S,10R,13S,14S)-3-hydroxy-10,13-dimethyl-1,2,3,4,7,8,9,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-one
- Test material form:
- solid
- Details on test material:
- white solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2004OCT0401
- Expiration date of the lot/batch: not specified
- Purity : 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
OTHER SPECIFICS:
- CAS Registry Number: 53-43-0
- Generic Name: Prasterone
- Chemical Name: 3β-hydroxy-5-androsten-17-one or 3β-hydroxyandrost-5-en-17-one
- Molecular Weight: 288.4
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on species / strain selection:
- recommended by Guideline
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: methylcellulose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
not specified
DIET PREPARATION
- Rate of preparation of diet (frequency): n/a
- Mixing appropriate amounts with (Type of food): n/a
- Storage temperature of food: n/a - Duration of treatment / exposure:
- 24 and 48hr
- Frequency of treatment:
- single treatment
- Post exposure period:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- vehicle control (0.4% methylcellulose) - harvest time 24 and 48 h
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- harvest time 24 h
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- harvest time 24 h
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- harvest time 24 and 48 h
- No. of animals per sex per dose:
- 5 males / harvest / timepoint
- Control animals:
- yes
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): recommended by Guideline
- Route of administration: oral - gavage
- Doses / concentrations: 80 mg/kg
Examinations
- Tissues and cell types examined:
- bone marrow tissue
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
top dose selected based on highest recommended dose in Guideline
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
24hr ; 48 hr (for top dose and vehicle control)
DETAILS OF SLIDE PREPARATION:
not specified
METHOD OF ANALYSIS:
not specified
- Evaluation criteria:
- According to OECD Guideline.
vehicle control should be less than 0.4% micronucleated PCE's. Statistically significant elevation of the positive control gp relative to the vehicle control gp needed. - Statistics:
- Statistical analysis of elevation relative to the vehicle control gp. The statistical method is not specified.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
no data
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): CP induced significantly more micronucleated PCE's (P<0.01) compared to the vehicle control. The test item did not induce any statistically relevant increases.
- Ratio of PCE/NCE (for Micronucleus assay): The ratio PCE:NCE was significantly decreased by CP (P<0.05) compared to the vehicle control. The test item did not induce any statistically relevant decreases.
- Appropriateness of dose levels and route: recommended by Guideline
- Statistical evaluation: not statistically significant
Applicant's summary and conclusion
- Conclusions:
- The test item was concluded to be negative in the in vivo mouse bone marrow micronucleus assay.
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