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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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