Registration Dossier
Registration Dossier
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EC number: 931-801-1 | CAS number: -
Endpoint summary
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 the structurally related substance erucamide (CAS 112-84-5) by the Lead Registrant of that substance, which will be used for read-across.
According to Regulation (EC) No 1907/2006, 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:
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, erucamide) is proposed by the respective Lead Registrant 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 for 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 oleamide 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 erucamide (CAS 112-84-5), which will be used for read-across.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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