Registration Dossier
Registration Dossier
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EC number: 215-237-7 | CAS number: 1314-60-9
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Publications with shortcomings: -purity and identity of the test material not described, -doses not analytically verified, -experimental procedure not sufficiently described, -
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Comparison of clastogenic effects of antimony and bismuth as trioxides on mice in vivo
- Author:
- Gurnani, N.; et al.
- Year:
- 1 993
- Bibliographic source:
- Biological Trace Element Research 37, 281-292
- Reference Type:
- publication
- Title:
- Comparison of clastogenic effects of antimony trioxide on mice in vivo following acute and chronic exposure
- Author:
- Gurnani, N.; et al.
- Year:
- 1 992
- Bibliographic source:
- Bio Metals 5, 47-50
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- sperm quality was monitored after 21 days of daily oral exposure with diantimony trioxide in an in vivo chromosome aberration test in germ cells
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diantimony trioxide
- EC Number:
- 215-175-0
- EC Name:
- Diantimony trioxide
- Cas Number:
- 1309-64-4
- Molecular formula:
- Sb2O3
- IUPAC Name:
- dioxodistiboxane
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 wks
- Weight at study initiation: 25-30g
- Fasting period before study:
- Housing:
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum): standard pellet diet
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (±3°C)
- Humidity (%): 50% (±15%)
- Photoperiod (hrs dark / hrs light): 12/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
400 mg/kg bw/day
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
667 mg/kg bw/day
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
nominal in water
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified Generation not specified (migrated information)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Within an in vivo chromosome aberration test, sperm abnormalities were monitored and compared with the control.
The frequency of abnormal sperms did not differ significantly between treated and control mice at the P=0.05 level, indicating that diantimony trioxide did not exert a marked effect on testes even after prolonged treatment.
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