Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 study available, testing not required as the substance is an Intermediate used under Strictly Controlled Conditions.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Additional information

The registered substance is an on-site isolated intermediate. Per the Guidance on Intermediates, "If the manufacturer confirms in his IUCLID registration dossier that the on-site isolated intermediate is manufactured and used under strictly controlled conditions (see section 2.1), the information requirements on the substance intrinsic properties (physicochemical, human health and environment properties) are reduced to already available data (e.g. information he holds himself or that he can obtain from other sources) and only study summaries have to be submitted even if a full study report is available (Article 17) (see 2.2)."

Effects on developmental toxicity

Description of key information

No study available, testing not required as the substance is an Intermediate used under Strictly Controlled Conditions.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Abnormalities:
not specified
Developmental effects observed:
not specified
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available

Justification for classification or non-classification

No studies are available. The registered substance is an on-site isolated intermediate and no further testing is required.

Additional information