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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
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2,6-dibromo-4-cyanophenyl heptanoate EC / List no: 260-300-4 | CAS no: 56634-95-8
2,6-dibromo-4-cyanophenyl butyrate EC / List no: 223-374-9 | CAS no: 3861-41-4
2,6-dibromo-4-cyanophenyl octanoate EC / List no: 216-885-3 | CAS no: 1689-99-2
3,5-dibromo-4-hydroxybenzonitrile EC / List no: 216-882-7 | CAS no: 1689-84-5
216-882-7
1689-84-5
Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
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Potassium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-998-3 | CAS no: 2961-68-4
Sodium 3,5-dibromo-4-hydroxyphenylcyanide EC / List no: 220-997-8 | CAS no: 2961-67-3
-
-
Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
216-881-1
1689-83-4
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
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3,5-Diiodo-4-hydroxybenzonitrile, lithium salt EC / List no: - | CAS no: 2961-61-7
Sodium 4-hydroxy-3,5-diiodophenylcyanide EC / List no: 220-995-7 | CAS no: 2961-62-8
-
-
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
216-885-3
1689-99-2
Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
223-375-4
3861-47-0
Repr. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
422-670-7
150202-11-2
Repr. 2; Acute Tox. 3; STOT RE 2
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
603-031-3
125116-23-6
Repr. 2; Acute Tox. 4
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
428-650-4
153719-23-4
Repr. 2; Acute Tox. 4
211-987-4
732-11-6
Repr. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 1
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
200-712-3
69-72-7
Repr. 2; Acute Tox. 4; Eye Dam. 1
230-625-6
7226-23-5
Repr. 2; Acute Tox. 4; Eye Dam. 1
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
421-310-6
87691-88-1
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
ASIL-322; OS-5200
421-870-1
156145-66-3
Repr. 2; Acute Tox. 4; STOT RE 2
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
261-043-0
57966-95-7
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
425-030-5
159939-85-2
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
430-550-0
1671-49-4
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
260-300-4
56634-95-8
Repr. 2; Acute Tox. 4; Skin Sens. 1
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
204-317-7
119-36-8
Repr. 2; Acute Tox. 4; Skin Sens. 1B
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
QUESTAMIDE H
422-560-9
149591-38-8
Repr. 2; Eye Irrit. 2
205-551-2
142-64-3
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
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
D,L-VALINEAMIDE
402-840-7
20108-78-5
Repr. 2; Eye Irrit. 2; Skin Sens. 1
221-695-9
3194-55-6
Repr. 2; Lact.
yes
262-095-7
60168-88-9
Repr. 2; Lact.
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beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
247-148-4
25637-99-4
Repr. 2; Lact.
yes
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
604-167-6
139968-49-3
Repr. 2; Lact.; STOT RE 2
UK-111,975
422-390-5
143322-57-0
Repr. 2; STOT RE 1; Acute Tox. 4; Skin Sens. 1
200-521-5
61-82-5
Repr. 2; STOT RE 2
600-533-4
104206-82-8
Repr. 2; STOT RE 2
254-637-6
39807-15-3
Repr. 2; STOT RE 2
432-270-4
221354-37-6
Repr. 2; STOT RE 2
-
138182-18-0
Repr. 2; STOT RE 2
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
216-474-9
1593-77-7
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
250-778-2
31717-87-0
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
[S]-2-INDOLINE CARBOXYLIC ACID
410-860-2
79815-20-6
Repr. 2; STOT RE 2; Skin Sens. 1
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
B2,4DBB
420-710-8
23085-60-1
Repr. 2; Skin Irrit. 2; Skin Sens. 1
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
SP 7053
415-930-6
-
Repr. 2; Skin Sens. 1
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
P-NITROBENZYLESTER PGSO
412-670-5
54275-93-3
Resp. Sens. 1
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
232-565-6
9000-90-2
Resp. Sens. 1
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Amylase, gluco-, Rhizopus oryzae EC / List no: - | CAS no: 152923-55-2
Amylase, α-, Aspergillus oryzae EC / List no: 232-588-1 | CAS no: 9001-19-8
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Amylase, fungal EC / List no: 232-742-8 | CAS no: 9013-01-8
Amylase, alpha-, Bacillus amyloliquefaciens EC / List no: - | CAS no: 152923-48-3
Amylase, gluco- EC / List no: 232-877-2 | CAS no: 9032-08-0
Amylase, iso- EC / List no: 232-956-1 | CAS no: 9067-73-6
Amylase EC / List no: 232-567-7 | CAS no: 9000-92-4
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Amylase, β- EC / List no: 232-566-1 | CAS no: 9000-91-3
Amylase, α- EC / List no: 232-565-6 | CAS no: 9000-90-2
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Amylase, bacterial EC / List no: 232-560-9 | CAS no: 9000-85-5
-
-
Resp. Sens. 1
204-650-8
123-77-3
Resp. Sens. 1
yes
253-465-9
37329-65-0
Resp. Sens. 1
232-734-4
9012-54-8
Resp. Sens. 1
-
-
Resp. Sens. 1
232-589-7
9001-22-3
Resp. Sens. 1
SP 807
420-150-4
80498-15-3
Resp. Sens. 1
C.I. REACTIVE RED 219
400-130-1
149057-72-7
Resp. Sens. 1
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
3-BMC
407-620-4
33610-13-8
Resp. Sens. 1; Skin Sens. 1
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
423-530-8
152828-23-4
STOT RE 1; Acute Tox. 4
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4

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