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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
21 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
In a one-generation study rats were exposed to concentration of 0, 200, 1500 and 11000 ppm via diet. The test has shown organ weight changes and a slightly reduced body weight gain at 1500 ppm in the F0 generation. Futuremore, slight organ weight changes were observed in the F1 offspring at the high and mid dose.These effects were not cosidered to be of toxicological significance.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
Based on the reproductive toxicity studies, PMC D-532 is not considered a reproductive toxicant for the rat.
In a developmental toxicity study rats were exposed by oral gavage to doses of 0, 100, 300 and 1000 mg/kg bw/d. The test has only shown slight increase in the incidence of foetuses with short lenght extra (14th) ribs at the higher dose (1000 mg/kg). Although it cannot be excluded that this effect is treatment related, it is not related with other skeletal defects and is not of enough importance to consider the substance a developmental toxicant.

Justification for classification or non-classification

Additional information