EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

RELEVANT LEGISLATION
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EU CLP (1272/2008)
Repr. 1B; Acute Tox. 3; Eye Irrit. 2

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
2-sec-butyl-4,6-dinitrophenol, compound with 2,2',2''-nitrilotriethanol (1:1) 229-166-4 6420-47-9 Expert judgement
2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1) 258-532-6 53404-43-6 Expert judgement
Ammonium 2-sec-butyl-4,6-dinitrophenolate 228-858-3 6365-83-9 Expert judgement
Dinoseb acetate 220-560-1 2813-95-8 Expert judgement
Binapacryl 207-612-9 485-31-4 Expert judgement
Sodium 2-(1-methylpropyl)-4,6-dinitrophenolate 252-331-7 35040-03-0 Expert judgement
2-sec-butyl-4,6-dinitrophenol, compound with 1-aminopropan-2-ol (1:1) 275-931-0 71735-19-8 Expert judgement