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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.