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Toxicological information

Toxicity to reproduction

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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:
1993
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:
1992
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

Constituent 1
Chemical structure
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

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.