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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 rujna 2024. Database contains 4821 unique substances/entries.
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CP-328,914
429-030-6
57999-49-2
Skin Sens. 1
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
SIS 46 305
408-010-0
88558-41-2
Acute Tox. 4; Eye Dam. 1
HOSTALUX VP 3481-1 HOSTALUX N2R
402-120-2
133514-97-3
Skin Corr. 1B; STOT RE 2; Skin Sens. 1
AZURANT PYRAZOLINE MR 5401; PYRAZOLINE BRIGHTENER MR 5401; UVITEX 4457
402-490-5
106359-93-7
Eye Irrit. 2
429-180-2
157362-53-3
Skin Sens. 1
TTP MAGENTA 3
405-480-9
110260-50-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
BRILLANT RED 1047729; BRILLIANT RED 1047729; ROUGE BRILLANT 1047729
405-440-0
149172-69-0
Skin Sens. 1
PIGMENT ADDITIV C
404-910-2
164578-14-7
Skin Sens. 1
FC-102B; M-3218
415-910-7
152828-25-6
Skin Sens. 1
420-200-5
1379676-70-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
428-320-1
71308-16-2
Acute Tox. 4; Skin Sens. 1
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
443-980-9
221215-20-9
Skin Sens. 1
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
XU 40304.03L ANTIMICROBIAL
405-640-8
36362-09-1
STOT RE 2; Skin Irrit. 2; Eye Dam. 1
KEINE
403-070-4
51395-42-7
Skin Corr. 1B; Skin Sens. 1
431-930-9
43028-69-9
Acute Tox. 4; Skin Sens. 1
MCPSI
410-900-9
83056-32-0
Flam. Liq. 3; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1
EM
405-350-1
54527-73-0
Skin Sens. 1
AMINOETHER
412-310-7
37866-45-8
Skin Sens. 1
420-830-0
102333-75-5
Eye Dam. 1; Skin Sens. 1
CSPC
411-010-3
117205-23-9
Skin Sens. 1
JEFFCAT ZF-10; TEXACAT ZF-10
406-080-7
83016-70-0
Acute Tox. 4; Skin Corr. 1B
CHLORGELB; HC YELLOW 12
413-280-8
59320-13-7
Acute Tox. 4
P-964
420-580-2
151798-26-4
Repr. 1B
425-760-4
64137-52-6
Eye Dam. 1
KAYACEL YELLOW CG; NO.466 BZN
407-680-1
98809-11-1
Eye Dam. 1; Skin Sens. 1
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
ATRAC 869
417-960-5
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-560-8
4274-38-8
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
DPX N6186; N 6186
410-050-9
5734-64-5
Acute Tox. 4
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
2-AMINO-5-METHYLTHIAZOL
423-800-5
7305-71-7
Acute Tox. 4; STOT RE 2
DPX-D-7556
403-580-7
62096-63-3
Acute Tox. 4
DAM 520
413-440-7
112006-75-4
Skin Sens. 1
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
EF-40
406-110-9
35950-52-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
DEBROPOL
407-030-7
24403-04-1
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
429-430-0
444-14-4
Acute Tox. 4
426-540-0
2973-59-3
Skin Sens. 1
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B

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