Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

According to Regulation (EC) No 1907/2006, Annex VIII, column 2, testing for the effects on fertility by a sccreening test is not required as a test for prenatal developmental toxicity (Annex IX, 8.7.2) is proposed for a structurally related substance (CAS 112-84-5) which will be used for read-across.

According to Regulation (EC) No 1907/2006, Annex IX, column 1, a 2-generation study for reproductive toxicity is not indicated unless repeated dose toxicity studies demonstrate adverse effects on reproductive organs. 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:
Waiving - Toxicity to reproduction screening
Waiving - Toxicity to reproduction 2-generation study

Effects on developmental toxicity

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

There is no data available on developmental toxicity and teratogenicity for oleamide.

Therefore, a Prenatal Developmental Toxicity Study (OECD 414) for the structurally related substance erucamide (CAS 112-84-5), which 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 oleamide. The utilisation of such surrogate data from a structurally related substance fro regulatory purposes is reasonable and justified, especially in the light of animal welfare and considering the physical chemical and toxicokinetic similarities of oleamide and erucamide. Therefore, no individual prenatal developmental toxicity study with stearamide is proposed.

Justification for classification or non-classification

According to the criteria of the DSD and the CLP regulation the substance 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 CAS 112-84-5, which will be used as read-across.