Registration Dossier
Registration Dossier
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EC number: 218-485-4 | CAS number: 2162-73-4
Endpoint summary
Administrative data
Description of key information
1) Key_Bioaccumulation: aquatic / sediment: BCFSSL= 4.5 - 6.1 L/kg for Onchorhynchus mykiss (flow-through, freshwater, OECD 305 -I: Aqueous Exposure Bioconcentration Fish Test,GLP)
2) Waiver_Bioaccumulation: aquatic / sediment: According to REACH Regulation (EC) No 1907/2006 Article 2 (9), polymers are excluded from Titles II (Registration) and VI (Evaluation).
Additional information
Bioaccumulation: aquatic / sediment
Due to the very fast hydrolysis (DT50= 37s) and the resulting instability of the test substance, it was considered most meaningful to cover the information on the bioaccumulative potential by the consideration of the degradation products. Based on the results of the hydrolysis study conducted at CURRENTA GmbH according to OECD 111, 2,4,6-triisopropyl-m-phenylene diamine (TRIDA, CAS 6318-09-08) was expected as major hydrolysis and polymeric ureas as potential minor hydrolysis product (Neuland, 2020).
Accordingly, the bioaccumulative potential was analysed for the main hydrolysis product 2,4,6-triisopropyl-m-phenylene diamine (TRIDA, CAS 6318-09-08).The study was running under GLP according to OECD TG 305-I using aqueous exosure. Based on the mean measured concentration of the test material in the test water, the bioconcentration factor was determined for steady state (BCFSS), including a normalisation to 5% lipid content (BCFSSL) and was 1.44-1.88 L/kg and 4.5-6.1 L/kg, respectively, indicating a low potential for bioaccumulation. As a worst-case assumption the upper value of 6.1 L/kg is taken as key value for further risk assessment.
Polymeric ureas are considered as polymers under REACH. Therefore they do not have to be registered and evaluated according to Chapter 1; Article 2, Paragraph 9 Regulation No. 1907/2006. Regardless of the evaluation of available data, the determination of the bioaccumulative potential of the polymeric ureas as minor hydrolysis product is waived accordingly.
Bioaccumulation: terrestrial
This is no mandatory endpoint to be fulfilled for a registration of a tonnage band of 100 - 1000 tons/year according to REACH Regulation (EC) 1907/2006.
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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