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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 lipnja 2024. Database contains 4821 unique substances/entries.
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427-370-1
164288-56-6
Eye Dam. 1
IMEXINE FAG
410-910-3
104226-19-9
Skin Sens. 1
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
225-918-0
5146-66-7
Muta. 1B
218-951-7
2300-66-5
Eye Irrit. 2
203-950-6
112-24-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-986-2
112-57-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
223-775-9
4067-16-7
Skin Corr. 1B; Skin Sens. 1
203-606-5
108-68-9
Acute Tox. 3; Skin Corr. 1B
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
DCATFOB; XRD 473 ANILINE
401-790-3
104147-32-2
Acute Tox. 4
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
220-630-1
2840-00-8
Acute Tox. 4
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
AF-389
407-990-7
141915-64-2
Skin Sens. 1
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B
210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
209-415-3
577-71-9
Acute Tox. 3; STOT RE 2
209-504-7
583-48-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
202-448-4
95-76-1
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
431-500-0
226065-73-2
Skin Sens. 1
209-230-8
562-49-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-243-9
563-16-6
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
200-261-2
56-18-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
204-355-4
119-90-4
Carc. 1B; Acute Tox. 4
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
440-770-9
371921-63-0
Eye Dam. 1
BASIC RED FC 48215
406-055-0
124584-00-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
COUPLER II; UC-136
406-200-8
117827-06-2
Skin Sens. 1
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
247-816-5
26571-11-9
yes
604-395-6
14409-72-4
yes
219-682-8
2497-59-8
yes
248-743-1
27942-27-4
yes
442-230-8
321679-52-1
Eye Dam. 1
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
687-833-9
1119449-38-5
yes
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
223-228-4
3775-90-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
205-411-0
140-31-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
426-400-9
170222-39-6
Skin Sens. 1
2-ADPS
413-030-8
1134-94-7
Skin Sens. 1
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
SALICYNALVA
423-460-8
3508-98-3
Acute Tox. 4
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
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1
204-589-7
122-99-6
Acute Tox. 4; STOT SE 3; Eye Dam. 1
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
209-474-5
581-89-5
Carc. 1B
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
202-547-2
96-96-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
205-182-7
135-19-3
Acute Tox. 4
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
SUBSTANCE S123386; VANQUISH 100
420-590-7
4299-07-4
Skin Corr. 1B; Skin Sens. 1
210-256-7
611-15-4
Acute Tox. 4
203-643-7
109-06-8
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
VINYLMILCHSÄURE-ISO-BUTYLESTER
406-235-9
72531-53-4
Eye Irrit. 2; Skin Irrit. 2
D(+)-LACTATE D'ISOBUTYLE
407-770-0
61597-96-4
Eye Irrit. 2
204-066-3
115-11-7
Flam. Gas 1; Press. Gas
200-889-7
75-65-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-148-0
78-83-1
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
203-489-0
107-41-5
Eye Irrit. 2; Skin Irrit. 2
220-239-6
2682-20-4
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
211-765-7
693-98-1
Repr. 1B
yes
209-730-6
591-76-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-747-9
592-27-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-513-6
583-60-8
Flam. Liq. 3; Acute Tox. 4
209-512-0
583-59-5
Acute Tox. 4
219-449-0
2438-20-2
Flam. Liq. 3
252-343-2
35073-27-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
210-843-8
624-41-9
Flam. Liq. 3
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
203-710-0
109-83-1
Acute Tox. 4; Skin Corr. 1B
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-039-0
91-08-7
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
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
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
PAMPLEFLEUR
402-770-7
92585-24-5
Skin Sens. 1
204-462-6
121-29-9
Acute Tox. 4
204-455-8
121-21-1
Acute Tox. 4
CG 31-1919
410-760-9
157661-93-3
Skin Irrit. 2; Skin Sens. 1
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
THANCAT AN 10
404-810-9
4524-95-2
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
433-910-5
145153-52-2
Skin Sens. 1
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
274-724-2
70657-70-4
Flam. Liq. 3; Repr. 1B; STOT SE 3
216-455-5
1589-47-5
Flam. Liq. 3; Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
204-659-7
123-88-6
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
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
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
213-611-4
994-05-8
Flam. Liq. 2; Acute Tox. 4; STOT SE 3
203-603-9
108-65-6
Flam. Liq. 3
FRESCOLAT MPC
417-420-9
156324-82-2
Eye Irrit. 2
A-87463.0
414-800-6
154212-60-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
406-970-5
129228-11-1
Skin Irrit. 2
203-685-6
109-59-1
Acute Tox. 4; Eye Irrit. 2
430-800-9
129228-21-3
Skin Irrit. 2
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
213-090-3
923-26-2
Eye Irrit. 2; Skin Sens. 1
FRESCOLAT MGA
408-200-3
63187-91-7
Skin Irrit. 2; Eye Dam. 1
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
212-782-2
868-77-9
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
212-454-9
818-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
200-909-4
75-86-5
Acute Tox. 2; Acute Tox. 1
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
444-860-9
474510-57-1
STOT RE 2
203-951-1
112-25-4
Acute Tox. 4; Skin Corr. 1B
202-627-7
98-01-1
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
211-363-1
640-19-7
Acute Tox. 2; Acute Tox. 3
428-100-3
94239-04-0
Flam. Liq. 3; Acute Tox. 4
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
2-FLUOR-4-HYDROXYBENZONITRIL
422-810-7
82380-18-5
Acute Tox. 4; Eye Dam. 1
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
279-452-8
80387-97-9
Repr. 1B; Skin Sens. 1
231-057-1
7425-14-1
Repr. 2
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
260-828-5
57583-34-3
Repr. 2
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
231-480-1
7580-31-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
205-743-6
149-57-5
Repr. 2
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
202-377-9
94-96-2
Eye Dam. 1
202-621-4
97-95-0
Acute Tox. 4
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
424-380-6
43057-68-7
Acute Tox. 4; STOT RE 2
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
C.I. DISPERSE RED 367
403-960-2
147014-52-6
Skin Sens. 1
203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
202-356-4
94-70-2
Acute Tox. 3; STOT RE 2
259-370-9
54839-24-6
Flam. Liq. 3; STOT SE 3
220-688-8
2867-47-2
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
203-275-7
105-16-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
202-845-2
100-37-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
434-270-1
6261-30-9
Skin Irrit. 2; Eye Dam. 1
431-400-7
57374-49-9
Skin Sens. 1
POLLENAL II
412-270-0
2109-22-0
Skin Sens. 1
423-740-1
10461-98-0
Acute Tox. 4
202-424-3
95-49-8
Acute Tox. 4
209-952-3
598-78-7
Acute Tox. 4; Skin Corr. 1A
200-858-8
75-29-6
Flam. Liq. 2; Acute Tox. 4
202-433-2
95-57-8
Acute Tox. 4
210-885-7
625-29-6
Flam. Liq. 2; Acute Tox. 4
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
203-459-7
107-07-3
Acute Tox. 2; Acute Tox. 1
212-836-5
873-32-5
Acute Tox. 4; Eye Irrit. 2
201-956-3
89-98-5
Skin Corr. 1B
2-CHLOR-4-TOLUOLSULFONYLCHLORID
412-890-1
42413-03-6
Skin Corr. 1B; Skin Sens. 1
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
ROT CO
411-440-1
131657-78-8
Acute Tox. 4; Skin Sens. 1
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
204-502-2
121-87-9
Acute Tox. 4
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 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
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
203-933-3
112-07-2
Acute Tox. 4
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
200-855-1
75-26-3
Flam. Liq. 2; Repr. 1A; STOT RE 2
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
426-540-0
2973-59-3
Skin Sens. 1
429-430-0
444-14-4
Acute Tox. 4

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