Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
other: review article
GLP compliance:
not specified
Species:
rat
Sex:
female
Route of administration:
other: oral, subcutaneous and intra-peritoneal
Duration of treatment / exposure:
3 days
Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day
Based on:
test mat.
Sex:
female
Basis for effect level:
other: see 'Remark'
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on fertility via oral route:
Note that the NOAEL of 100 mg/kg/d was with intra-peritoneal application.
With subcutaneous application a NOAEL of 250 mg/kg/d was observed.
Effects were also seen after oral application but unfortunately that study did not indicate the dosages used.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

With a NOAEL for toxicity to reproduction of 100 mg/kg/day after intra-peritoneal application, respectively 250 mg/kg/day after subcutaneous application, the substance should be classified as reproductive toxicant Category 2 with H361 (suspected of damaging fertility)