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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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203-985-7
112-56-1
Flam. Liq. 3; Acute Tox. 3
203-988-3
112-59-4
Acute Tox. 4; Eye Dam. 1
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
203-906-6
111-77-3
Repr. 2
247-384-8
25973-55-1
yes
253-037-1
36437-37-3
yes
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
425-050-4
10217-34-2
Skin Sens. 1
M-TMI
402-440-2
2094-99-7
Acute Tox. 2; Skin Corr. 1B; STOT RE 2; Resp. Sens. 1; Skin Sens. 1
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
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 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
201-289-8
80-54-6
Repr. 1B
yes
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2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
799-970-2
-
yes
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
203-052-4
102-77-2
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
EM
405-350-1
54527-73-0
Skin Sens. 1
AMINOETHER
412-310-7
37866-45-8
Skin Sens. 1
222-598-4
3547-33-9
Eye Dam. 1
420-830-0
102333-75-5
Eye Dam. 1; Skin Sens. 1
220-548-6
2807-30-9
Acute Tox. 4; Eye Irrit. 2
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
205-592-6
143-22-6
Eye Dam. 1
243-816-4
20427-84-3
yes
230-770-5
7311-27-5
yes
P-964
420-580-2
151798-26-4
Repr. 1B
425-760-4
64137-52-6
Eye Dam. 1
618-344-0
9002-93-1
yes
687-832-3
1119449-37-4
yes
KAYACEL YELLOW CG; NO.466 BZN
407-680-1
98809-11-1
Eye Dam. 1; Skin Sens. 1

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