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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
[S]-2-INDOLINE CARBOXYLIC ACID
410-860-2
79815-20-6
Repr. 2; STOT RE 2; Skin Sens. 1
250-778-2
31717-87-0
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
216-474-9
1593-77-7
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
-
138182-18-0
Repr. 2; STOT RE 2
432-270-4
221354-37-6
Repr. 2; STOT RE 2
254-637-6
39807-15-3
Repr. 2; STOT RE 2
600-533-4
104206-82-8
Repr. 2; STOT RE 2
200-521-5
61-82-5
Repr. 2; STOT RE 2
UK-111,975
422-390-5
143322-57-0
Repr. 2; STOT RE 1; Acute Tox. 4; Skin Sens. 1
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
604-167-6
139968-49-3
Repr. 2; Lact.; STOT RE 2
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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
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
247-148-4
25637-99-4
Repr. 2; Lact.
yes
262-095-7
60168-88-9
Repr. 2; Lact.
221-695-9
3194-55-6
Repr. 2; Lact.
yes
D,L-VALINEAMIDE
402-840-7
20108-78-5
Repr. 2; Eye Irrit. 2; Skin Sens. 1
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
QUESTAMIDE H
422-560-9
149591-38-8
Repr. 2; Eye Irrit. 2
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
204-317-7
119-36-8
Repr. 2; Acute Tox. 4; Skin Sens. 1B
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
260-300-4
56634-95-8
Repr. 2; Acute Tox. 4; Skin Sens. 1
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
425-030-5
159939-85-2
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
261-043-0
57966-95-7
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
ASIL-322; OS-5200
421-870-1
156145-66-3
Repr. 2; Acute Tox. 4; STOT RE 2
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
421-310-6
87691-88-1
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A

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