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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

OECD 422: 50 mg/Kg bw/day was determined to be the NOAEL (No Observed Adverse Effect Level) for systemic and developmental toxicity in rats.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
One key Guideline (OECD 422) combined repeated dose, reproductive developmental toxicity screening study in rats available for assessment.
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

Description of key information

Dose range-finding pre-natal developmental toxicity: The test material exhibited maternal toxicity when administered at 1000 mg/Kg/day while it was well tolerated when administered to pregnant rats for 14 days (Days 6-19 post coitum), up to the dose level of 100 mg/Kg/day.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
One key pre-natal developmental toxicity dose range-finding study in rats available for assessment.
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

Based on the available information derived from the experimantal study conducteed on the substance. No classification is warranted according to the CLP Regulation (EC n. 1272/2008).

Additional information