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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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)

Additional information