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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

No effects on fertility or offspring development were observed in a screening study with rats (OECD 421) performed with doses of up to 1000 mg/kg bw.

Effect on fertility: 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:
Screening study (OECD 421)
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
Study duration:
subacute
Species:
rat
Quality of whole database:
Screening study (OECD 421)
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

The available screening study is reliable and suitable for classification purposes under Regulation 1272/2008. No adverse effects were noted at the limit dose of 1000 mg/kg bw. As a result the substance is not considered to be classified for fertility or developmental toxicity under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.

During the four days covered in the screening study, no effects via lactation were observed.

Additional information