Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance was non-mutagenic in a bacterial reverse mutation assay according to OECD TG 471 with 5 Salmonella typhimurium-strains (TA 1535, TA 100, TA 1537, TA 98, TA 102).

For assessment of further genotoxicity endpoints a read across from the close structural analogue HDI oligomers, isocyanurate type (EC 931-274-8, CAS 28182-81-2, UVCB) is applied. This substance is a close structural analogue to (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate (EC 223-242-0, CAS 3779-63-3, mono constituent substance), in the following referred to as "HDI Trimer pure". A justification for the read-across with special focus on inhalation toxicity was elaborated and is attached to this endpoint summary. Based on this justification all available toxicological data for HDI oligomers, isocyanurate type can be used for the toxicological evaluation of HDI Trimer pure. This approach is in accordance with Annex XI, section 1.5 of the REACH Regulation (EC) No 1907/2006.

(All available studies for HDI oligomerisation product (isocyanurate type), EC 931-274-8, athttp://echa.europa.eu/web/guest/information-on-chemicals/registered-substances).

 

Read across to HDI oligomers, isocyanurate type gave no evidence of mammalian cell mutagenicity (report no. 50M0355/064102, 2007, HPRT, OECD TG 476) or in vitro chromosome aberration (report no. 32M0355/064051, 2007, CAb/OECD TG 473). Therefore, it was concluded that HDI Trimer pure is no genetic toxicant.

 


Justification for selection of genetic toxicity endpoint
None of the available studies is selected since all are relevant for the assessment of genetic toxicity.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is required for genetic toxicity according to Regulation (EC) No 1272/2008, Annex I.