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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study with sufficient detail.

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:
review article or handbook
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Principles of method if other than guideline:
Type: other: male reproduction organs
Method: other: no guideline was followed
GLP compliance:
no
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
0.08 other: mmole/kg bw
Sex:
male

Any other information on results incl. tables

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