Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
According to Column 2 of Annex VIII of REACH Regulation, the screening for reproductive/developmental toxicity does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI section 3. To support this statement  the chosen route is based on Annex XI 3.2 (a) and derived DNELs.
Effect on fertility: via oral route
Endpoint conclusion:
no study available
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 study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Toxicity to reproduction: other studies

Additional information

The available long-term repeated dose studies show that the substance has a low toxicological activity and negligible systemic absorption. To support that the human exposure is not significant, each life cycle stage and each relevant use, the exposure estimate has been calculated and the conditions for PEL/DNEL << 1 have been established. The relevant exposure scenarios have been included in the CSR included in this dossier.

Justification for classification or non-classification

Based on the available information the substance is not classified as reproductive toxicant.