Registration Dossier
Registration Dossier
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EC number: 931-297-3 | CAS number: -
Endpoint summary
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 endpoints of genetic toxicity a read across to HDI oligomers, isocyanurate type (EC 931 -274 -8) is applied. This substance is a close structural analogue to HDI oligomers, iminooxadiazindione type, also derived from catalytic oligomerisation of 1,6 -hexamethylene diisocyanate (HDI; CAS 822 -06 -0) and also belonging to the CAS number 28182-81-2 (Hexane, 1,6 - diisocyanato-, homopolymer). The read across is based on physicochemical and toxicological similarity. In fact, comparison of the toxicological endpoints, that are available for both of the two substances reveal good correlation.
| Toxicological endpoint | HDI oligomers, isocyanurate type | HDI oligomers, iminooxadiazindione type |
| Acute oral toxicity | > 2000 mg/kg | > 2000 mg/kg |
| Acute inhalation toxicity (pulmonary irritant study) | NOAEL 3 mg/m³ | NOAEL 2.1 mg/m³ |
| Skin Irritation/Corrosion | slight irritation/no classification required | slight irritation/no classification required |
| Eye Irritation/Corrosion | very slight irritation/no classification required | very slight irritation/no classification required |
| Skin Sensitisation | classification required | classification required |
| Bacterial Mutagenicity (Ames) | negative | negative |
With respect to Inhalation Toxicity an expert statement is available justifying the read across (Pauluhn, Comparison of pulmonary irritation potency..., Bayer HealthCare AG, 2008).
Therefore, test results obtained for HDI oligomers, isocyanurate type can be transferred to HDI oligomers, iminooxadiazindione type and the data of genetic toxicity for HDI oligomers, isocyanurate type are also valid for HDI oligomers, iminooxadiazindione type. This approach is in accordance with Annex XI, section 1.5 of the REACH Regulation (Regulation (EC) No 1907/2006).
Read across to the HDI oligomers, isocyanurate type gave no evidence of mammalian cell mutagenicity (report no. 50M0355/064102, 2007, HPRT; report no. 1053/027, 2004, mouse lymphoma assay; both OECD TG 476) or of in vitro/in vivo chromosome aberration (report no. 32M0355/064051, 2007, CAb/OECD TG 473; report no. 4110, 1986, MNT/OECD TG 474). Therefore it was concluded that HDI oligomers, iminooxadiazindione type 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
According to Regulation (EC) No 1272/2008, Annex I, no classification is warranted for genetic toxicity.
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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