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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 travnja 2024. Database contains 4821 unique substances/entries.
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200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; 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
201-025-1
77-40-7
yes
209-321-2
569-61-9
Carc. 1B
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
209-218-2
561-41-1
yes
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
B-TUM
418-770-5
151882-81-4
Carc. 2
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
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
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
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
225-863-2
5124-30-1
Acute Tox. 3; 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
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
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
DD-63
404-590-4
90884-29-0
Skin Sens. 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
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
-
-
Carc. 1B; Acute Tox. 4
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
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
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
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
-
-
yes
621-341-7
2315-61-9
yes
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
423-860-2
56309-94-5
Skin Sens. 1
257-907-1
52427-13-1
yes
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
635-388-6
521947-27-3
yes
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
-
-
yes
272-233-8
68784-25-8
yes
MORTRACE ST CONC.
410-600-8
124719-26-2
STOT RE 2; Skin Irrit. 2
635-389-1
186825-36-5
yes
635-391-2
142731-63-3
yes
635-696-0
186825-39-8
yes
CARBODIM
413-120-7
107144-30-9
Acute Tox. 4
250-863-4
31906-04-4
Skin Sens. 1A
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
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
4-(4-PROPYLCYCLOHEXYL)-ACETOPHENON
406-700-6
78531-61-0
Skin Sens. 1
425-030-5
159939-85-2
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
PLAKATROT Z; ROT BN
406-305-9
92952-81-3
Skin Irrit. 2
M.E.M.P.E.
407-940-4
111681-72-2
Eye Dam. 1
PSL 6
411-400-3
102089-33-8
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
ANTHRACHINON BLAU 27 HD
406-057-1
114565-66-1
Carc. 2; Skin Sens. 1
420-220-4
92771-56-7
Skin Sens. 1
CIN 10097929
418-320-8
133467-41-1
Acute Tox. 4
NAVY DER 7850
417-640-5
161935-19-9
Eye Dam. 1; Skin Sens. 1
NITROBLAU; NITROBLUE
407-020-2
132885-85-9
Acute Tox. 4; Skin Sens. 1
OXAMITOL
412-510-4
135043-64-0
Acute Tox. 4; Skin Sens. 1
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
FAP
402-230-0
399-95-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
202-214-1
93-05-0
Acute Tox. 3; Skin Corr. 1B
202-807-5
99-98-9
Acute Tox. 3
200-453-6
60-09-3
Carc. 1B
yes
204-616-2
123-30-8
Muta. 2; Acute Tox. 4
VMZ95005
418-100-1
172964-15-7
Skin Sens. 1
4-BROM-2-CHLORFLUORBENZOL; 4-BROMO-2-CHLOROFLUOROBENZENE
405-580-2
60811-21-4
Acute Tox. 4; Skin Irrit. 2
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
216-381-3
1570-64-5
Acute Tox. 3; Skin Corr. 1A
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
221-627-8
3165-93-3
Carc. 1B; Muta. 2; Acute Tox. 3
203-401-0
106-47-8
Carc. 1B; Acute Tox. 3; Skin Sens. 1
CHLORO ESTER; CHLOROESTER
410-950-1
69788-75-6
Skin Sens. 1
203-402-6
106-48-9
Acute Tox. 4
ACC ETHER
405-260-2
94050-51-8
Acute Tox. 4; Skin Sens. 1
203-176-9
104-12-1
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
203-397-0
106-43-4
Acute Tox. 4
204-581-3
122-88-3
Acute Tox. 4
CORANOL
420-630-3
83926-73-2
Eye Dam. 1
401-130-4
71526-07-3
Skin Sens. 1
DIAZO-A-SALICYLSULFONATE
404-980-4
124737-31-1
Self-react. C; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
ZOLDINE (R) MS-52
410-470-2
137796-06-6
Skin Corr. 1B; Skin Sens. 1
RO 827
412-090-2
2788-74-1
Acute Tox. 4; Skin Sens. 1
432-560-0
61721-07-1
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
438-670-5
87199-17-5
Skin Sens. 1

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