Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

According to Regulation (EC) No 1907/2006, Annex VIII, 8.7.1, column 2, testing for the effects on fertility by a screening test is not required as a test for prenatal developmental toxicity (Annex IX, 8.7.2) is proposed for the structurally related substance erucamide (CAS 112-84-5) by the Lead Registrant for that substance, who is also a member of the Fatty Amides Consortium, which will be used for read-across.

According to Regulation (EC) No 1907/2006, Annex IX, 8.7.3, column 1, a 2-generation study for reproductive toxicity is not indicated unless repeated dose toxicity studies demonstrate adverse effects on reproductive organs or tissues. A subchronic repeated dose toxicity study is proposed for the structurally related substance erucamide (CAS 112-84-5) by the Lead Registrant for that substance, who is also a member of the Fatty Amides Consortium, which will be used for read-across; therefore the need for a 2-generation study is dependent on the outcome of the proposed test.


Short description of key information:
Data waiving - Toxicity to reproduction screening
Data waiving - Toxicity to reproduction 2-generation study

Effects on developmental toxicity

Description of key information
Data waiving - Prenatal Developmental Toxicity study (OECD 414) for structurally related substance (CAS 112-84-5) is proposed which will be used for read-across.
Additional information

There is no data available on developmental toxicity and teratogenicity for Amides, C16-C18 (even numbered).

Therefore, a Prenatal Developmental Toxicity Study (OECD 414) for the structurally related substance erucamide (CAS 112-84-5), that has been proposed by the Lead Registrant for that substance, who is also a member of the Fatty Amides Consortium, will be shared and used for read-across to satisfy the data requirements for developmental toxicity / teratogenicity of Amides, C16-C18 (even numbered). The utilisation of such surrogate data from a structurally related substance for regulatory purposes is reasonable and justified according to Regulation (EC) No 1907/2006, Annex XI, article 1.5, especially in the light of animal welfare and considering the physical chemical and toxicokinetic similarities of Amides, C16-C18 (even numbered) and erucamide. Therefore, no individual prenatal developmental toxicity study with Amides, C16-C18 (even numbered) is proposed.

Justification for classification or non-classification

According to the criteria of EU Directive 67/548/EEC and the criteria of Regulation (EC) No 1272/2008 Amides, C16-C18 (even numbered) cannot be classified for toxicity to reproduction at the moment due to a lack of data. The required studies have been proposed for the structurally related substance erucamide (CAS 112-84-5), which will be used for read-across.