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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 srpnja 2024. Database contains 4821 unique substances/entries.
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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
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
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
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
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
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
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
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
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
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
430-840-7
202483-63-4
Skin Sens. 1
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
204-626-7
123-42-2
Eye Irrit. 2
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
2-METHOXY-4-METHYL-6-METHYLAMINO-1,3,5-TRIAZIN; DPX-L5296; L5296
401-360-5
5248-39-5
Acute Tox. 4; STOT RE 2
425-860-8
125971-57-5
Skin Sens. 1
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
209-544-5
584-84-9
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
203-550-1
108-10-1
Flam. Liq. 2; Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-204-7
92-93-3
Carc. 1B
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
211-535-6
659-49-4
Acute Tox. 4
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
419-240-6
171054-89-0
Eye Dam. 1
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
202-848-9
100-40-3
Carc. 2
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
204-525-8
122-15-6
Acute Tox. 3
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
251-684-4
33813-20-6
Acute Tox. 4
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
IMEXINE OAY
412-130-9
3131-52-0
Acute Tox. 4; Eye Dam. 1
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
410-530-8
107815-88-3
Skin Sens. 1
WAY-128170
420-820-6
153042-18-3
Flam. Liq. 3; Acute Tox. 4
-
51-14-9
Acute Tox. 4
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
CDFP
410-090-7
89402-43-7
Flam. Liq. 3; Acute Tox. 4
429-290-0
3380-30-1
Eye Dam. 1
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
414-470-3
95885-13-5
Acute Tox. 4
619-823-7
494793-67-8
Carc. 2
208-793-7
541-85-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
210-025-0
602-87-9
Carc. 1B
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
441-550-5
-
Self-react. C; Carc. 2
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
239-732-2
15662-33-6
Acute Tox. 4
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
202-095-6
91-76-9
Acute Tox. 4
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
424-850-0
189702-72-5
Eye Dam. 1
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
429-400-7
199327-61-2
Repr. 1B
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
421-940-1
28698-31-9
Eye Dam. 1
416-360-0
162221-28-5
Skin Sens. 1
M1
422-060-0
137390-08-0
Acute Tox. 2
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
426-890-4
77341-67-4
Eye Dam. 1
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
419-270-1
123599-82-6
Eye Irrit. 2
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
425-520-9
197179-61-6
Eye Dam. 1
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B

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