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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 28 March 2024. Database contains 4821 unique substances/entries.
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215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
233-162-8
10049-04-4
Acute Tox. 3; Skin Corr. 1B
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
203-577-9
108-39-4
Acute Tox. 3; Skin Corr. 1B
215-293-2
1319-77-3
Acute Tox. 3; Skin Corr. 1B
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
203-398-6
106-44-5
Acute Tox. 3; Skin Corr. 1B
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
200-677-4
68-11-1
Acute Tox. 3; Skin Corr. 1B
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
203-440-3
106-90-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
212-454-9
818-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
INTERSEPT
404-690-8
68132-19-4
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
209-132-5
556-61-6
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
237-499-1
13820-41-2
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
233-050-9
10025-99-7
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
R-THP
415-110-8
54417-53-7
Acute Tox. 4
444-320-2
-
Acute Tox. 4
CZ-AMIDE; PTH-TETRAHYDROAMIDE; TETRAHYDROAMIDE (THA)
414-600-9
149182-72-9
Acute Tox. 4
430-100-3
86978-24-7
Acute Tox. 4
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
200-756-3
71-55-6
Acute Tox. 4
246-147-6
24307-26-4
Acute Tox. 4
RO 1173
414-270-6
41959-35-7
Acute Tox. 4
3,4-DIACETOXY-1-BUTENE
421-720-5
18085-02-4
Acute Tox. 4
256-152-5
43222-48-6
Acute Tox. 4
208-792-1
541-73-1
Acute Tox. 4
429-370-5
220410-74-2
Acute Tox. 4
204-081-5
115-31-1
Acute Tox. 4
246-011-6
24083-03-2
Acute Tox. 4
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
209-990-0
600-25-9
Acute Tox. 4
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
419-570-0
195006-58-7
Acute Tox. 4

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