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).

Last updated 24 svibnja 2024. Database contains 4917 unique substances/entries.
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284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
284-349-6
84852-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
Details
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
Details
284-032-2
84777-06-0
Repr. 1B
R Toxic for reproduction (article 57c)
Details
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
283-931-7
84776-07-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
283-930-1
84776-06-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Azadirachta indica, Meliaceae.
283-644-7
84696-25-3
Repr. 2; Skin Sens. 1
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills in the approximate range of 200°C to 250°C (392°F to 482°F).
283-484-8
84650-04-4
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150°C to 210°C (302°F to 410°F).
283-483-2
84650-03-3
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
Details
430-390-1
845730-14-5
Acute Tox. 4
Details
430-280-3
844491-96-9
Skin Sens. 1
Details
282-714-4
84332-86-5
Carc. 2
Details
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
Details
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
Details
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
282-263-3
84145-37-9
Flam. Liq. 3
Details
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
Details
281-985-6
84082-38-2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
201-559-5
84-75-3
Repr. 1B
R Toxic for reproduction (article 57c)
Details
201-557-4
84-74-2
Repr. 1B
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
201-553-2
84-69-5
Repr. 1B
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
201-549-0
84-65-1
Carc. 1B
Details
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
CORANOL
420-630-3
83926-73-2
Eye Dam. 1
Details
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
Details
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
Details
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
C Carcinogenic (article 57a)
Details
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
Details
4-(4-BUTYLCYCLOHEXYL)-ACETOPHENON
427-320-7
83626-30-6
Skin Sens. 1
Details
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
212-634-7
834-12-8
Acute Tox. 4
Details
MCPSI
410-900-9
83056-32-0
Flam. Liq. 3; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1
Details
F5384
401-340-6
83055-99-6
Skin Sens. 1
Details
JEFFCAT ZF-10; TEXACAT ZF-10
406-080-7
83016-70-0
Acute Tox. 4; Skin Corr. 1B
Details
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
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83-59-0
Acute Tox. 3; Acute Tox. 4
Details
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
Details
280-084-5
82985-35-1
Eye Dam. 1
Details
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
Details
GM 102 E
411-370-1
82857-68-9
Acute Tox. 3; Eye Dam. 1
Details
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
Details

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