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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
205-138-7
134-32-7
Acute Tox. 4
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
214-012-0
1072-63-5
Repr. 1B
yes
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
BLEU DISPERSE 370; BLEU DISPERSO 370; BLEU LIP 6994; C.I. DISPERSE BLUE 370; DISPERS BLAU 370; DISPERSE BLUE 370
403-010-7
106359-94-8
Skin Sens. 1
BLEU 1047679; BLUE 1047679
405-200-5
104366-25-8
Skin Sens. 1
BLEU 1044098; BLUE 1044098
405-190-2
122371-93-1
Skin Sens. 1
203-872-2
111-46-6
Acute Tox. 4
216-853-9
1680-21-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-312-7
105-59-9
Eye Irrit. 2
214-237-4
1116-54-7
Carc. 1B
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-874-3
111-48-8
Eye Irrit. 2
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
DMBA
424-090-1
10097-02-6
Eye Dam. 1
233-539-7
10222-01-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
236-236-8
13252-13-6
yes
-
1065124-65-3
Acute Tox. 4; STOT SE 2
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
203-440-3
106-90-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
203-441-9
106-91-2
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; STOT RE 1; Eye Dam. 1; Skin Corr. 1C; Skin Sens. 1
-
130014-35-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
239-714-4
15646-96-5
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
203-486-4
107-39-1
Flam. Liq. 2
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
423-560-1
161717-32-4
Skin Sens. 1
203-614-9
108-77-0
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
204-639-8
123-63-7
Flam. Liq. 3
204-289-6
118-96-7
Expl. 1.1; Acute Tox. 3; STOT RE 2
429-610-9
1030366-98-3
Acute Tox. 4; Eye Dam. 1
429-600-4
1026988-42-0
Acute Tox. 4; Eye Dam. 1
BASISCH GELB 8511
407-010-8
118208-02-9
Acute Tox. 4; Eye Dam. 1
CYCLOWOOD
405-340-7
13019-04-0
Skin Irrit. 2
PM 9879
401-060-4
121518-45-4
Skin Corr. 1B
204-429-6
120-83-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
434-820-9
106461-41-0
STOT RE 2
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
203-548-0
108-08-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
203-321-6
105-67-9
Acute Tox. 3; Skin Corr. 1B
LYRISAL
405-690-0
114119-97-0
Skin Irrit. 2; Skin Sens. 1
MR-8A; MR-N2; NBDI
411-280-2
161973-12-2
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
430-170-5
114625-74-0
Acute Tox. 4
HR-11
419-770-8
136122-15-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
444-250-2
144111-81-9
Self-react. C
VIOLETT MIP 3250
424-120-1
174514-06-8
Eye Dam. 1
FPB 800
427-400-1
140623-89-8
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
T 1049
403-350-6
17742-69-7
Acute Tox. 3
203-620-1
108-83-8
Flam. Liq. 3; STOT SE 3
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
PIGMENT ADDITIV AC; PIGMENTADDITIV AC
404-230-6
164578-11-4
Skin Sens. 1
FAT 40'398; FAT 40'398/E
411-100-2
136213-73-5
STOT RE 2; Skin Sens. 1
RO 1082
411-260-3
117907-43-4
Eye Dam. 1; Skin Sens. 1
METHYLGELB
408-090-7
100418-33-5
Acute Tox. 4; Skin Sens. 1
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
31 AC-HCL
410-620-7
119154-86-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-867-5
111-41-1
Repr. 1B; Skin Corr. 1B; Skin Sens. 1
203-961-6
112-34-5
Eye Irrit. 2
203-985-7
112-56-1
Flam. Liq. 3; Acute Tox. 3
203-988-3
112-59-4
Acute Tox. 4; Eye Dam. 1
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
203-906-6
111-77-3
Repr. 2
425-050-4
10217-34-2
Skin Sens. 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
203-052-4
102-77-2
Eye Irrit. 2; Skin Irrit. 2; 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
205-592-6
143-22-6
Eye Dam. 1
P-964
420-580-2
151798-26-4
Repr. 1B
687-832-3
1119449-37-4
yes
204-709-8
124-68-5
Eye Irrit. 2; Skin Irrit. 2
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
205-483-3
141-43-5
Acute Tox. 4; Skin Corr. 1B
203-541-2
108-00-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
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
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
203-933-3
112-07-2
Acute Tox. 4
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-CHLORO-4,5-DIFLUORO BENZOIC ACID; BA-6; CDFBA
405-380-5
110877-64-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1

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