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EC number: 931-801-1
CAS number: -
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.
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.
There is no data available on developmental toxicity and teratogenicity
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.
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.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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