EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 20 lipnja 2024. Database contains 4821 unique substances/entries.
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284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
284-032-2
84777-06-0
Repr. 1B
yes
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
283-931-7
84776-07-8
yes
283-930-1
84776-06-7
yes
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
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
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
430-390-1
845730-14-5
Acute Tox. 4
430-280-3
844491-96-9
Skin Sens. 1
282-714-4
84332-86-5
Carc. 2
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
282-263-3
84145-37-9
Flam. Liq. 3
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
281-985-6
84082-38-2
yes
201-559-5
84-75-3
Repr. 1B
yes
201-557-4
84-74-2
Repr. 1B
yes
201-553-2
84-69-5
Repr. 1B
yes
201-549-0
84-65-1
Carc. 1B
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
CORANOL
420-630-3
83926-73-2
Eye Dam. 1
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
4-(4-BUTYLCYCLOHEXYL)-ACETOPHENON
427-320-7
83626-30-6
Skin Sens. 1
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
212-634-7
834-12-8
Acute Tox. 4
MCPSI
410-900-9
83056-32-0
Flam. Liq. 3; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1
F5384
401-340-6
83055-99-6
Skin Sens. 1
JEFFCAT ZF-10; TEXACAT ZF-10
406-080-7
83016-70-0
Acute Tox. 4; Skin Corr. 1B
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
83-59-0
Acute Tox. 3; Acute Tox. 4
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
280-084-5
82985-35-1
Eye Dam. 1
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
GM 102 E
411-370-1
82857-68-9
Acute Tox. 3; Eye Dam. 1
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
CIN 10096132; MTI
407-630-9
82633-79-2
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
212-557-9
826-62-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4

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