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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study with sufficient detail. For justification of read across see endpoint summary.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Antitesticular effect of metallic and rare earth salts.
Author:
Kamboj, V. P. and Kar, A. B.
Year:
1964
Bibliographic source:
J. Reprod. Fertil. 7, 21-28
Reference Type:
secondary source
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Observation of male reproduction organs
GLP compliance:
no
Type of method:
in vivo

Test material

Constituent 1
Reference substance name:
Silicic acid, sodium salt
EC Number:
215-687-4
EC Name:
Silicic acid, sodium salt
Cas Number:
1344-09-8
IUPAC Name:
sodium hydroxy(oxo)silanolate
Details on test material:
SOURCE: Not indicated
PURITY: Not indicated
IMPURITY/ADDITIVE/ETC.: Not indicated
ANY OTHER INFORMATION: Molar ratio not indicated

Test animals

Species:
rat
Strain:
other: swiss albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ORGANISMS
- weight at study initiation: 100-120 g

Administration / exposure

Route of administration:
other: intratesticularly or subcutaneously
Vehicle:
water
Details on exposure:
- Total volume applied: 0.2 mL
Duration of treatment / exposure:
once
Frequency of treatment:
once
Duration of test:
7 days
Doses / concentrations
Remarks:
Doses / Concentrations:
0.08 mmole/kg bw
Basis:

Control animals:
yes, concurrent vehicle
Details on study design:
EXAMINATIONS: 
- Morphology of testis
- Histology of testis
- Weight of testis
- Spermatozoa in the ductus deferens

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 0.08 other: mmole/kg bw
Based on:
test mat.
Sex:
male

Observed effects

TOXIC RESPONSE/EFFECTS BY DOSE LEVEL: 
- Morphology: no alteration of the rat testis.
- Histology: no alteration of the rat testis.
- Organ weight: slight reduction in testis weight.
- Spermatozoa: no effect on spermatozoa in the ductus deferens of the rats.

Applicant's summary and conclusion

Conclusions:
No morphological or histological effects of testes were seen in either application route nor was there any effect on residual spermatozoa in the ductus deferens.
Executive summary:

In a study by Kamboj and Kar (1964), male rats were injected subcutaneously and intratesticularly with doses of 0.08 mmole/kg sodium silicate. When the testes were examined 7 d after injection, Testicular weight was slightly reduced as compared to controls injected with sterile water.