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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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2-ADPS
413-030-8
1134-94-7
Skin Sens. 1
426-400-9
170222-39-6
Skin Sens. 1
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
442-230-8
321679-52-1
Eye Dam. 1
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
COUPLER II; UC-136
406-200-8
117827-06-2
Skin Sens. 1
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
BASIC RED FC 48215
406-055-0
124584-00-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
440-770-9
371921-63-0
Eye Dam. 1
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
431-500-0
226065-73-2
Skin Sens. 1
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
AF-389
407-990-7
141915-64-2
Skin Sens. 1
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
DCATFOB; XRD 473 ANILINE
401-790-3
104147-32-2
Acute Tox. 4
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
IMEXINE FAG
410-910-3
104226-19-9
Skin Sens. 1
427-370-1
164288-56-6
Eye Dam. 1
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 1
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
424-530-0
93076-03-0
Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-EHOPD; EHOPD; GE-EH; SENSIVA SC 50
408-080-2
70445-33-9
Eye Dam. 1
5-(3-PYRIDYL)-TETRAZOL
426-810-8
3250-74-6
Eye Dam. 1
128719
401-460-9
82560-06-3
Acute Tox. 3; Eye Dam. 1
G 19-675 ZP
403-920-4
107551-67-7
Acute Tox. 4; Eye Irrit. 2
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
426-370-7
1017183-70-8
Skin Corr. 1A; Acute Tox. 4
424-170-4
130603-71-3
Skin Sens. 1
431-030-6
163269-30-5
Acute Tox. 3; STOT RE 2; Eye Dam. 1
CM 22-447
402-540-6
105254-85-1
Skin Corr. 1B; Skin Sens. 1
7-PACA
415-750-8
106447-44-3
Skin Sens. 1
PARMANYL
415-220-6
142653-61-0
Acute Tox. 3; Acute Tox. 4
3-(DIMETHYLAMINO)PROPYL UREA; HST 2844
401-950-2
31506-43-1
Eye Dam. 1
FYROL 3-HPP; HIRETAR-205; PHOSGARD PF 100
411-200-6
14657-64-8
Eye Dam. 1
IMEXINE FAE
403-440-5
93633-79-5
Acute Tox. 4
421-310-6
87691-88-1
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
425-370-4
93957-50-7
Skin Sens. 1
ADDITIVE F6
421-600-2
719-86-8
STOT RE 2
FAT 92.346 B
411-520-6
112195-27-4
Eye Dam. 1; Skin Sens. 1
427-780-9
114565-70-7
Acute Tox. 4; Eye Dam. 1
SUBSTANCE S68494
412-230-2
4403-70-7
Acute Tox. 4; Skin Corr. 1B
ASB
405-310-3
15980-11-7
Self-react. C; STOT RE 2; Eye Dam. 1; Skin Sens. 1
426-750-2
151860-15-0
Skin Sens. 1
3-CHLORO-2,4-DIFLUORONITROBENZENE
411-980-8
3847-58-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
CA 2272 A
421-700-6
179104-32-6
Skin Irrit. 2
3-CHLORO-4,5-DIFLUOROBENZOTRIFLUORIDE
401-930-3
77227-99-7
Flam. Liq. 3; Acute Tox. 4
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
ACTF; P-007
401-670-0
79456-26-1
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
ISOPHORONENITRILE, IPN
411-490-4
7027-11-4
Acute Tox. 4; STOT RE 2; Skin Sens. 1
SANDUVOR 3056
411-920-0
106917-30-0
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
UK-48,340
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
428-700-5
1873-90-1
Acute Tox. 4
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
433-900-0
55066-49-4
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
SUBSTANCE S44176
414-570-7
18759-96-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
432-530-7
24294-01-7
Acute Tox. 4
CC14837; SKF 106224
414-990-0
302-97-6
Repr. 2
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
DMA
407-500-1
21983-80-2
Skin Sens. 1
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
B-TUM
418-770-5
151882-81-4
Carc. 2
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1
AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
DD-63
404-590-4
90884-29-0
Skin Sens. 1
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
421-360-9
148043-73-6
Acute Tox. 4
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
HOMOFARNESYLSÄURE
403-000-2
91853-67-7
Skin Irrit. 2
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
423-860-2
56309-94-5
Skin Sens. 1
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
WL 125892
402-190-4
113674-95-6
STOT RE 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1
MORTRACE ST CONC.
410-600-8
124719-26-2
STOT RE 2; Skin Irrit. 2
CARBODIM
413-120-7
107144-30-9
Acute Tox. 4
MORTRACE SB CONC.
410-610-2
111850-24-9
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
JKY-120
405-730-7
51601-57-1
STOT RE 2
426-900-7
203118-12-1
STOT SE 3

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