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Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
other: Read Across Source
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
no guideline followed
Principles of method if other than guideline:
ADMINISTRATION / EXPOSURE
- Type: colony bred rats
- Strain: Swiss albino
- weight at study initiation: 100-120 g
- Type of exposure: single intratesticular or subcutaneous
injection.

- Duration of test/exposure: 7 days
- Vehicle: sterile distilled water
- Concentration in vehicle: not reported
- Total volume applied: 0.2 ml
- Doses: 0.08 mmole/kg bw
- Concentrations: not reported
- Control: sterile distilled water. For intratesticular
injection the right testis served as control and the left
testis received the test substance.

EXAMINATIONS:
- Morphology of testis
- Histology of testis
- Weight of testis
- Spermatozoa in the ductus deferens
GLP compliance:
no
Species:
rat
Strain:
Swiss
Sex:
male
Route of administration:
other: single intratesticular or subcutaneous injection.
Vehicle:
water
Duration of treatment / exposure:
7 days
Dose / conc.:
9.76 mg/kg bw (total dose)
Positive control:
Yes
Key result
Dose descriptor:
NOAEL
Effect level:
> 9.76 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
clinical signs
organ weights and organ / body weight ratios
histopathology: non-neoplastic
histopathology: neoplastic
Remarks on result:
not measured/tested
Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
9.76 mg/kg bw/day (actual dose received)

Justification for classification or non-classification

Additional information

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