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Toxicological information

Toxicity to reproduction: other studies

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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:
1980
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

Constituent 1
Chemical structure
Reference substance name:
Sodium selenate
EC Number:
236-501-8
EC Name:
Sodium selenate
Cas Number:
13410-01-0
Molecular formula:
Na2SeO4
IUPAC Name:
disodium selenate
Test material form:
solid: crystalline
Details on test material:
MW: 188,95
no impurities reported

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

At 60 µmol/kg body weight, spontaneuos death of treated rats was first observed (no statistical analysis provided), and the percentage of mortality rised with rising dose. A dose on 100 µmol/kg body weight had a 100% lethal effect.

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.