Registration Dossier
Registration Dossier
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EC number: 939-657-1 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Based on a read across from a substance with a similar composition (HDI oligomerisation product, isocyanurate type, EC 931-274-8, CAS 28182-81-2) a data waiving is claimed for toxicity to reproduction for HDI oligomerisation product, allophanate-type. The read across is based on physicochemical and toxicological similarity of the two substances. Especially a recently conducted comparative pulmonary irritant potency study based on the recommendations of TRGS 430 (Technical Rule for Hazardous Substances 430; published by the German Federal Ministry of Labour and Social Affairs, last update 2009) confirmed for HDI oligomerisation product, allophanate-type the same toxicological mode of action (irritant portal of entry toxicity) with a similar potency (NOAECs: 3.4 mg/m³ for HDI oligomerisation product, allophanate-type versus 3.3 mg/m³ for HDI oligomerisation product, isocyanurate type). For further justification of the grouping and read-across according to regulation (EC) No 1907/2006, Annex XI, 1.5 see document attached to chapter "Assessment Reports".
The full and detailed waiving text for the reproductive toxicity/fertility study, that was originally elaborated for "Aliphatic Diisocyanate Monomers and their Polyisocyanates" like HDI oligomerisation product, isocyanurate type, is attached to this endpoint summary.
Effects on developmental toxicity
Additional information
Based on a read across from a substance with a similar composition (HDI oligomerisation product, isocyanurate type, EC 931-274-8, CAS 28182-81-2) a data waiving is claimed for developmental toxicity for HDI oligomerisation product, allophanate-type. The read across is based on physicochemical and toxicological similarity of the two substances. Especially a recently conducted comparative pulmonary irritant potency study based on the recommendations of TRGS 430 (Technical Rule for Hazardous Substances 430; published by the German Federal Ministry of Labour and Social Affairs, last update 2009) confirmed for HDI oligomerisation product, allophanate-type the same toxicological mode of action (irritant portal of entry toxicity) with a similar potency (NOAECs: 3.4 mg/m³ for HDI oligomerisation product, allophanate-type versus 3.3 mg/m³ for HDI oligomerisation product, isocyanurate type). For further justification of the grouping and read-across according to regulation (EC) No 1907/2006, Annex XI, 1.5 see document attached to chapter "Assessment Reports".
The full and detailed waiving text for the developmental toxicity study, that was originally elaborated for "Aliphatic Diisocyanate Monomers and their Polyisocyanates" like HDI oligomerisation product, isocyanurate type, is attached to this endpoint summary.Justification for classification or non-classification
No classification required for toxicity to reproduction according to Regulation (EC) No 1272/2008, Annex I.
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.
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.
