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Registration Dossier
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EC number: 236-501-8 | CAS number: 13410-01-0
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxic effect of various selenium compounds on the rat in early postnatal period
- Author:
- Ostadalova I, Babicky A
- Year:
- 1 980
- Bibliographic source:
- Archives of Toxicology 45:207-211
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Test procedure is briefly outlined in the publication
- Type of method:
- in vivo
Test material
- Reference substance name:
- Sodium selenate
- EC Number:
- 236-501-8
- EC Name:
- Sodium selenate
- Cas Number:
- 13410-01-0
- Molecular formula:
- Na2SeO4
- IUPAC Name:
- sodium selenate
- Test material form:
- solid: crystalline
- Details on test material:
- MW: 188,95
no impurities reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- breeding colony VELAZ.
Animals were housed in litters which were adjusted on the day following birth, so that eight suckling males were placed to one mother.
Exposure started at day 10 post-birth
Administration / exposure
- Route of administration:
- subcutaneous
- Details on exposure:
- a single subcutaneous injection; doses were determined on the basis of preliminary experiments, so that the lowest dose had no cataractogenic effect while the highest was lethal.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- exposure via injection
- Frequency of treatment:
- single injection at day 1 of the experiment (= day 10 post-natal)
- Duration of test:
- 50 days (= postnatal day 60)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 other: µmol/kg body weight
- Dose / conc.:
- 20 other: µmol/kg body weight
- Dose / conc.:
- 40 other: µmol/kg body weight
- Dose / conc.:
- 60 other: µmol/kg body weight
- Dose / conc.:
- 80 other: µmol/kg body weight
- Dose / conc.:
- 100 other: µmol/kg body weight
- No. of animals per sex per dose:
- 30 animals per dose, except for 80 µmol/kg body weight (n=31) and 100 µmol/kg body weight (n=32).
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- animals were dosed via a single subcutaneous injectino at the start of the exposure period (age: 10 days).
Mortality was monitored, and the occurence of cataract was registered daily after the eyes opened (post-natal day 14-16). Animals were weaned at the age of 30 days anf henceforth fed with a standard laboratory diet and water at libitum. The experiment was terminated on postnatal day 60. - Statistics:
- No information provided
Results and discussion
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 other: µmol/kg body weight
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- ophthalmological examination
- Dose descriptor:
- NOAEL
- Effect level:
- 40 other: µmol/kg body weight
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- mortality
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 20 other: 20 µmol/kg body weight
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- ophthalmological examination
Observed effects
Any other information on results incl. tables
60 µmol/kg body weight: no mortality after 24 hours, 10% mortality after 7 days
80 µmol/kg body weight: 65% mortality after 24 hours, 71% mortality after 7 days
100 µmol/kg body weight: 100% mortality after 24 hours.
Cataract:
10 µmol/kg body weight: 0% cataract
20 µmol/kg body weight: 57% cataract
40 µmol/kg body weight: 93% cataract
60 µmol/kg body weight: 96% cataract
80 µmol/kg body weight: 89% cataract
Applicant's summary and conclusion
- Conclusions:
- The toxic effect of sodium selenate was tested in 10-day old male rats. Increasing doses of the compound were administered an s.c. injection and control animals were not injected. The compound proved to be lethal, and eye lens cataract was induced by the administration of disodium selenate. The cataractogenic effect may be attributed to their interference with glutathione metabolism.
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