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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
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433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
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-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
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 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
204-502-2
121-87-9
Acute Tox. 4
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
201-956-3
89-98-5
Skin Corr. 1B
212-836-5
873-32-5
Acute Tox. 4; Eye Irrit. 2
203-459-7
107-07-3
Acute Tox. 2; Acute Tox. 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
210-885-7
625-29-6
Flam. Liq. 2; Acute Tox. 4
202-433-2
95-57-8
Acute Tox. 4
200-858-8
75-29-6
Flam. Liq. 2; Acute Tox. 4
209-952-3
598-78-7
Acute Tox. 4; Skin Corr. 1A
202-424-3
95-49-8
Acute Tox. 4
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
202-845-2
100-37-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
203-275-7
105-16-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-542-8
108-01-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
220-688-8
2867-47-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
259-370-9
54839-24-6
Flam. Liq. 3; STOT SE 3
202-356-4
94-70-2
Acute Tox. 3; STOT RE 2
203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
C.I. DISPERSE RED 367
403-960-2
147014-52-6
Skin Sens. 1
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
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
202-621-4
97-95-0
Acute Tox. 4
202-377-9
94-96-2
Eye Dam. 1
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
205-743-6
149-57-5
Repr. 2
231-480-1
7580-31-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
260-828-5
57583-34-3
Repr. 2
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
231-057-1
7425-14-1
Repr. 2
279-452-8
80387-97-9
Repr. 1B; 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
211-363-1
640-19-7
Acute Tox. 2; Acute Tox. 3
202-627-7
98-01-1
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-951-1
112-25-4
Acute Tox. 4; Skin Corr. 1B
444-860-9
474510-57-1
STOT RE 2
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
200-909-4
75-86-5
Acute Tox. 2; Acute Tox. 1
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
212-454-9
818-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
212-782-2
868-77-9
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 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
213-090-3
923-26-2
Eye Irrit. 2; Skin Sens. 1
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
430-800-9
129228-21-3
Skin Irrit. 2
203-685-6
109-59-1
Acute Tox. 4; Eye 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
203-603-9
108-65-6
Flam. Liq. 3
213-611-4
994-05-8
Flam. Liq. 2; Acute Tox. 4; STOT SE 3
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
221-499-3
3121-61-7
Flam. Liq. 3; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1
204-659-7
123-88-6
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
216-455-5
1589-47-5
Flam. Liq. 3; Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
274-724-2
70657-70-4
Flam. Liq. 3; Repr. 1B; STOT SE 3
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
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
204-455-8
121-21-1
Acute Tox. 4
204-462-6
121-29-9
Acute Tox. 4
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

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