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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 rujna 2024. Database contains 4821 unique substances/entries.
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220-114-6
2631-40-5
Acute Tox. 4
220-113-0
2631-37-0
Acute Tox. 3
247-570-9
26266-63-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
247-554-1
26259-45-0
Acute Tox. 4; Eye Irrit. 2
435-010-8
26157-73-3
Muta. 2
E.M.A.
406-790-7
26116-56-3
Eye Dam. 1
247-449-0
26087-47-8
Acute Tox. 4
247-430-7
26043-11-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
4-(4-ETHYLCYCLOHEXYL)-ACETOPHENON
426-460-6
260415-81-4
Skin Sens. 1
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
220-012-1
2602-46-2
Carc. 1B; Repr. 2
247-384-8
25973-55-1
yes
219-997-0
2597-03-7
Acute Tox. 4
GOLPANOL APC
412-740-5
25965-81-5
Acute Tox. 4; Skin Sens. 1
219-993-9
2595-54-2
Acute Tox. 3
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
219-989-7
2592-95-2
Expl. 1.3
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
247-278-1
25808-74-6
Repr. 1A; Acute Tox. 4; STOT RE 2
219-943-6
2580-56-5
yes
-
25747-83-5
yes
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
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1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
247-148-4
25637-99-4
Repr. 2; Lact.
yes
247-143-7
25637-27-8
Acute Tox. 4
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
X4261
401-850-9
255881-94-8
yes
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
247-109-1
25567-67-3
Acute Tox. 3; STOT RE 2
247-096-2
25550-58-7
Acute Tox. 3; STOT RE 2
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
432-860-1
255387-46-3
Skin Sens. 1
246-948-0
25402-06-6
Acute Tox. 4
219-818-6
2540-82-1
Acute Tox. 4
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
246-901-4
25366-23-8
Acute Tox. 4
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
-
2532-43-6
Acute Tox. 3
246-831-4
25319-90-8
Acute Tox. 4
246-814-1
25311-71-1
Acute Tox. 3
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
440-460-3
252579-81-0
Eye Irrit. 2
500-036-1
25214-70-4
yes
246-698-2
25168-05-2
Acute Tox. 4
246-691-4
25167-80-0
Acute Tox. 4
246-690-9
25167-70-8
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3

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