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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 lipnja 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
2-CHLORO-4,5-DIFLUORO BENZOIC ACID; BA-6; CDFBA
405-380-5
110877-64-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
ROT CO
411-440-1
131657-78-8
Acute Tox. 4; Skin Sens. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
2-CHLOR-4-TOLUOLSULFONYLCHLORID
412-890-1
42413-03-6
Skin Corr. 1B; Skin Sens. 1
B8510-020; CHLORMETHYLPYRIDIN; CHLORMETHYLPYRIDINE; CHLOROMETHYLPYRIDINE
416-440-5
72830-09-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
423-740-1
10461-98-0
Acute Tox. 4
POLLENAL II
412-270-0
2109-22-0
Skin Sens. 1
431-400-7
57374-49-9
Skin Sens. 1
434-270-1
6261-30-9
Skin Irrit. 2; Eye Dam. 1
C.I. DISPERSE RED 367
403-960-2
147014-52-6
Skin Sens. 1
424-380-6
43057-68-7
Acute Tox. 4; STOT RE 2
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-FLUOR-4-HYDROXYBENZONITRIL
422-810-7
82380-18-5
Acute Tox. 4; Eye Dam. 1
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
428-100-3
94239-04-0
Flam. Liq. 3; Acute Tox. 4
444-860-9
474510-57-1
STOT RE 2
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
FRESCOLAT MGA
408-200-3
63187-91-7
Skin Irrit. 2; Eye Dam. 1
430-800-9
129228-21-3
Skin Irrit. 2
406-970-5
129228-11-1
Skin Irrit. 2
A-87463.0
414-800-6
154212-60-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
FRESCOLAT MPC
417-420-9
156324-82-2
Eye Irrit. 2
433-910-5
145153-52-2
Skin Sens. 1
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
THANCAT AN 10
404-810-9
4524-95-2
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
CG 31-1919
410-760-9
157661-93-3
Skin Irrit. 2; Skin Sens. 1
PAMPLEFLEUR
402-770-7
92585-24-5
Skin Sens. 1
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
444-970-7
7340-90-1
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
D(+)-LACTATE D'ISOBUTYLE
407-770-0
61597-96-4
Eye Irrit. 2
VINYLMILCHSÄURE-ISO-BUTYLESTER
406-235-9
72531-53-4
Eye Irrit. 2; Skin Irrit. 2
SUBSTANCE S123386; VANQUISH 100
420-590-7
4299-07-4
Skin Corr. 1B; Skin Sens. 1
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1
2-PHENYLETHYLISOCYANAT; 2-PHENYLETHYLISOCYANATE; PHENYL ETHYL ISOCYANATE
413-080-0
1943-82-4
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
SALICYNALVA
423-460-8
3508-98-3
Acute Tox. 4

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