Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
two-generation reproductive toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please see read across justification section 13.2
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
ca. 10 100 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: no effects reported at the highest dose tested.
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 10 100 mg/kg bw/day (actual dose received)
Sex:
male/female
Basis for effect level:
other: No effects on fertility of F1 generation wre observed at the highest dose.
Dose descriptor:
NOAEL
Remarks:
developmental effects, propylene glycol
Generation:
F2
Effect level:
ca. 10 100 mg/kg bw/day (actual dose received)
Sex:
male/female
Basis for effect level:
other: No effects on litter size, sex and pup weight in F2 pups were observed at the highest dose.
Reproductive effects observed:
not specified
Executive summary:

The test substance has a NOAEL of 10 100 mg/kg bw/day in a two generation reprotox study.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
126 mg/kg bw/day
Study duration:
chronic
Species:
mouse
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information