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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
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ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
257-907-1
52427-13-1
yes
423-860-2
56309-94-5
Skin Sens. 1
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
-
-
yes
621-341-7
2315-61-9
yes
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
HOMOFARNESYLSÄURE
403-000-2
91853-67-7
Skin Irrit. 2
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
421-360-9
148043-73-6
Acute Tox. 4
-
-
Carc. 1B; Acute Tox. 4
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
DD-63
404-590-4
90884-29-0
Skin Sens. 1
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
B-TUM
418-770-5
151882-81-4
Carc. 2
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
209-218-2
561-41-1
yes
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
209-321-2
569-61-9
Carc. 1B
201-025-1
77-40-7
yes
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
DMA
407-500-1
21983-80-2
Skin Sens. 1
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
209-526-7
584-02-1
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
CC14837; SKF 106224
414-990-0
302-97-6
Repr. 2
432-530-7
24294-01-7
Acute Tox. 4
215-925-7
1453-58-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Corr. 1; Eye Dam. 1
-
2532-43-6
Acute Tox. 3
202-481-4
96-14-0
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-643-3
589-34-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-660-6
589-81-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-264-3
563-80-4
Flam. Liq. 2
SUBSTANCE S44176
414-570-7
18759-96-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
433-900-0
55066-49-4
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
223-861-6
4098-71-9
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
209-130-4
556-56-9
Flam. Liq. 2; Skin Corr. 1B
259-627-5
55406-53-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1
220-426-2
2761-09-3
Eye Irrit. 2; Skin Sens. 1
LUPEROX 610-E-35; LUPEROX 610-E-50; LUPEROX 610-EN-50; LUPEROX 610-M-50; LUPERSOL 610; LUPERSOL 610-M-50
413-910-1
1467668-33-2
Org. Perox. C; Flam. Liq. 3; Skin Irrit. 2
428-700-5
1873-90-1
Acute Tox. 4
210-529-0
617-78-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-621-0
619-99-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
213-923-0
1067-08-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-187-2
609-26-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
UK-48,340
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
SANDUVOR 3056
411-920-0
106917-30-0
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
ISOPHORONENITRILE, IPN
411-490-4
7027-11-4
Acute Tox. 4; STOT RE 2; Skin Sens. 1
203-580-5
108-41-8
Acute Tox. 4
CHLOROFORMIATE DE CHLORO 3 PROPYLE
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-457-6
107-05-1
Flam. Liq. 2; Carc. 2; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-582-6
108-43-0
Acute Tox. 4
210-467-4
616-20-6
Flam. Liq. 2; Acute Tox. 4
-
15271-41-7
Acute Tox. 2; Acute Tox. 3
ACTF; P-007
401-670-0
79456-26-1
Acute Tox. 4
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
3-CHLORO-4,5-DIFLUOROBENZOTRIFLUORIDE
401-930-3
77227-99-7
Flam. Liq. 3; Acute Tox. 4
209-251-2
563-47-3
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
CA 2272 A
421-700-6
179104-32-6
Skin Irrit. 2
3-CHLORO-2,4-DIFLUORONITROBENZENE
411-980-8
3847-58-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
622-370-8
1522-92-5
yes
426-750-2
151860-15-0
Skin Sens. 1
ASB
405-310-3
15980-11-7
Self-react. C; STOT RE 2; Eye Dam. 1; Skin Sens. 1
213-048-4
919-30-2
Acute Tox. 4; Skin Corr. 1B
203-680-9
109-55-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-236-4
104-78-9
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
209-711-2
591-27-5
Acute Tox. 4
220-666-8
2855-13-2
Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
SUBSTANCE S68494
412-230-2
4403-70-7
Acute Tox. 4; Skin Corr. 1B
204-473-6
121-47-1
Acute Tox. 4
205-057-7
132-32-1
Carc. 1B
427-780-9
114565-70-7
Acute Tox. 4; Eye Dam. 1
FAT 92.346 B
411-520-6
112195-27-4
Eye Dam. 1; Skin Sens. 1
208-293-9
520-45-6
Acute Tox. 4
ADDITIVE F6
421-600-2
719-86-8
STOT RE 2
425-370-4
93957-50-7
Skin Sens. 1

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