Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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
Additional information

An oral pre-natal developmental toxicity study of Flyadd-3 (CAS No. 135861-56-2) is proposed. In accordance with Column 2 of ANNEX VIII of the REACH regulation, screening for reproductive/developmental toxicity study does not need to be conducted as an oral pre-natal developmental toxicity study will be available.


Justification for selection of Effect on fertility via oral route:
In accordance with Column 2 of ANNEX VIII of the REACH regulation, screening for reproductive/developmental toxicity study does not need to be conducted as a pre-natal developmental toxicity study will be available.

Justification for selection of Effect on fertility via inhalation route:
In accordance with Column 2 of ANNEX VIII of the REACH regulation, screening for reproductive/developmental toxicity study does not need to be conducted as an oral pre-natal developmental toxicity study will be available.

Justification for selection of Effect on fertility via dermal route:
In accordance with Column 2 of ANNEX VIII of the REACH regulation, screening for reproductive/developmental toxicity study does not need to be conducted as an oral pre-natal developmental toxicity study will be available.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
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

An oral pre-natal developmental toxicity study of Flyadd-3 (CAS No. 135861-56-2) is proposed.

Justification for classification or non-classification

Based on the available information in the dossier, no classification can be made on the reproductive toxicity of the substance Flyadd-3 (CAS No. 135861-56-2) as insufficient data is available. When new data becomes available from the proposed testing, the classification will be updated based on the criteria outlined in Annex I of 1272/2008/EC