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Key value for chemical safety assessment

Effects on fertility

Additional information
Short description of key information:
If the results of the sub-chronic study (90 day), proposed by the lead registrant to cover the end-point of Annex IX, section 8.6.2, indicate adverse effects on reproductive organs or tissues then an OECD guideline 416 two generation reproduction toxicity study in the rat by an appropriate route of administration is proposed by the lead registrant as per the requirement of REACH Annex IX, Section 8.7.3.

Effects on developmental toxicity

Description of key information
OECD guideline 414 Developmental Toxicity studies in the rat and rabbit are proposed by the lead registrant as per the requirement of REACH Annexes IX and X and ECHA RIP 3.3, Chapter R.7A, Section R.7.6.6.4.  Conduct of the second study will be dependent upon the outcome of the first study.

Justification for classification or non-classification

Data lacking

Additional information

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