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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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240-983-5
16923-58-3
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
9,10-ANTHRACENEDIOL, DISODIUM SALT
426-030-8
46492-07-3
Skin Corr. 1A
423-730-5
250688-43-8
Eye Dam. 1
SCARLET X-GA 1491
410-390-8
147703-64-8
Eye Dam. 1
EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
404-600-7
129009-88-7
Skin Sens. 1
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
YELLOW DO 2286
412-530-3
157627-98-0
Eye Dam. 1; Skin Sens. 1
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
YELLOW JB 1238
423-110-4
-
Eye Dam. 1
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
PRODUKT 1096
414-230-8
-
Skin Sens. 1
432-980-4
243858-60-8
Eye Dam. 1
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
REACTIVE BLUE FC 60866
414-040-5
149530-93-8
Acute Tox. 4; Skin Sens. 1
427-310-2
180850-95-7
Eye Dam. 1
SÄUREBRAUN 8507
404-930-1
118556-91-5
Acute Tox. 4; Eye Dam. 1
223-714-6
4032-26-2
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
201-579-4
85-00-7
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
205-565-9
142-84-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
203-869-6
111-43-3
Flam. Liq. 2; STOT SE 3
-
83-59-0
Acute Tox. 3; Acute Tox. 4
233-050-9
10025-99-7
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
215-197-0
1312-73-8
Skin Corr. 1B
231-781-8
7727-21-1
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
240-979-3
16921-30-5
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
220-639-0
2844-92-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
-
-
P Parasites
215-242-4
1314-80-3
Flam. Sol. 1; Water-react. 1; Acute Tox. 4
-
19372-20-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
251-087-9
32536-52-0
Repr. 1B
204-539-4
122-39-4
Acute Tox. 3; STOT RE 2
CYRACURE (R) PHOTOINITIATOR UVI-6974; CYRACURE PHOTOINITIATOR UVI-6976
403-500-0
159120-95-3
Skin Sens. 1
278-355-8
75980-60-8
Repr. 2
251-084-2
32534-81-9
STOT RE 2; Lact.
427-300-8
79463-77-7
Eye Dam. 1
213-482-4
957-51-7
Acute Tox. 4
201-434-5
82-66-6
Acute Tox. 2; STOT RE 1
-
-
P Parasites
235-702-8
12578-12-0
yes
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
230-253-4
6988-21-2
Acute Tox. 3
223-292-3
3811-49-2
Acute Tox. 3; STOT SE 1
222-883-3
3648-18-8
Repr. 1B; STOT RE 1
293-901-5
91648-39-4
Repr. 1B; STOT RE 1
show/hide
Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
799-973-9
-
yes
215-813-8
1420-07-1
Repr. 1B; Acute Tox. 2; Acute Tox. 3
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
yes
620-422-4
4097-36-3
Acute Tox. 3
-
63919-26-6
Acute Tox. 4
254-408-0
39300-45-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
213-546-1
973-21-7
Acute Tox. 3
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
247-096-2
25550-58-7
Acute Tox. 3; STOT RE 2
234-126-4
10544-72-6
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
246-673-6
25154-54-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
617-485-5
76714-88-0
Acute Tox. 4
215-217-8
1314-06-3
Carc. 1A; STOT RE 1; Skin Sens. 1
235-033-1
12059-14-2
Carc. 1A; STOT RE 1; Skin Sens. 1
234-828-0
12035-64-2
Carc. 1A; STOT RE 1; Skin Sens. 1
237-411-1
13775-54-7
Carc. 1A; STOT RE 1; Skin Sens. 1
238-946-3
14874-78-3
Carc. 1A; STOT RE 1; Skin Sens. 1
238-426-6
14448-18-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
234-494-6
12007-01-1
Carc. 1A; STOT RE 1; Skin Sens. 1
205-042-5
131-89-5
Acute Tox. 3
604-712-8
149961-52-4
Carc. 2; Repr. 2; Acute Tox. 4
215-993-8
1468-37-7
Acute Tox. 4
208-884-1
544-97-8
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
236-412-4
13360-57-1
Carc. 1B; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
209-805-3
593-74-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
301-323-2
93983-68-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
SUMQUAT 6040
404-050-8
123312-54-9
Eye Irrit. 2
203-508-2
107-64-2
Eye Dam. 1
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
432-860-1
255387-46-3
Skin Sens. 1
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
204-065-8
115-10-6
Flam. Gas 1; Press. Gas
210-871-0
624-92-0
Flam. Liq. 2; Acute Tox. 3; STOT SE 3; STOT SE 1; Eye Irrit. 2; Skin Sens. 1
210-478-4
616-38-6
Flam. Liq. 2
620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
C.I. DISPERSE BLUE 356
400-460-6
118578-14-6
Skin Sens. 1
432-310-0
617-55-0
Flam. Liq. 3; Eye Dam. 1; Skin Sens. 1
404-200-2
110488-70-5
Repr. 1B
200-480-3
60-51-5
Acute Tox. 4
605-329-9
163515-14-8
Acute Tox. 4; Skin Sens. 1
256-625-6
50563-36-5
Acute Tox. 4; Skin Sens. 1
215-629-8
1335-31-5
Expl. 1.1; Acute Tox. 3; STOT RE 2
233-307-5
10112-91-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
262-784-2
61432-55-1
Acute Tox. 4
204-076-8
115-26-4
Acute Tox. 1; Acute Tox. 2
BLUE GS 1259 R5
407-230-4
126637-70-5
Acute Tox. 4; Skin Sens. 1
REACTIVE ORANGE F-64 258 FW
401-010-1
106027-83-2
Skin Sens. 1
203-326-3
105-74-8
Org. Perox. D
211-617-1
674-82-8
Flam. Liq. 3; Acute Tox. 4
203-558-5
108-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
203-560-6
108-20-3
Flam. Liq. 2; STOT SE 3
210-088-4
605-50-5
Repr. 1B
yes
248-523-5
27554-26-3
Repr. 1B
276-090-2
71850-09-4
Repr. 1B
yes
201-553-2
84-69-5
Repr. 1B
yes
201-559-5
84-75-3
Repr. 1B
yes
200-760-5
71-63-6
Acute Tox. 3; STOT RE 2
600-594-7
104653-34-1
Repr. 1B; Acute Tox. 1; STOT RE 1
IRB
418-070-1
141714-54-7
Skin Sens. 1
209-161-3
557-20-0
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
425-380-9
7397-46-8
Pyr. Liq. 1; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
211-000-7
627-44-1
Acute Tox. 2; Acute Tox. 1; STOT RE 2
DIETHYLDIMETHYLAMMONIUMHYDROXIDE
419-400-5
95500-19-9
Acute Tox. 4; Skin Corr. 1A
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-716-3
109-89-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
431-430-0
103976-28-9
Acute Tox. 4
CS 100; SILOXAL
401-160-8
55426-95-4
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A
DAMA
426-790-0
162208-27-7
Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
SIFOSIL; SIFOSIL KONZENTRAT G 96-00 FEST
401-770-4
148324-78-1
Skin Corr. 1B; Acute Tox. 4
-
-
Acute Tox. 4
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
DCPMS; DYNASYLAN 9415; EURENOR 5023; SAN-30; WACKER SILAN CP2-DIMETHOXY; Z-6228
404-370-8
126990-35-0
Skin Irrit. 2; Eye Dam. 1
208-704-1
538-75-0
Acute Tox. 3; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
221-515-9
3129-91-7
Acute Tox. 4
202-980-7
101-83-7
Acute Tox. 4; Skin Corr. 1B
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
205-494-3
141-66-2
Acute Tox. 2; Acute Tox. 3
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
215-270-7
1317-39-1
Acute Tox. 4; Eye Dam. 1
215-572-9
1332-65-6
Acute Tox. 4; Acute Tox. 3
204-082-0
115-32-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
257-141-8
51338-27-3
Acute Tox. 4; Skin Sens. 1
620-436-0
75736-33-3
Eye Irrit. 2
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
236-881-5
13530-68-2
yes
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
D-2,4-DP; DICHLORPROP-P; DUPLOSAN DP-ACID
403-980-1
15165-67-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
204-390-5
120-36-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
200-838-9
75-09-2
Carc. 2
222-583-2
3542-36-7
Repr. 1B; Acute Tox. 2; STOT RE 1
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
201-199-9
79-36-7
Skin Corr. 1A
201-207-0
79-43-6
Skin Corr. 1A
220-487-5
2782-57-2
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
204-210-5
117-80-6
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
214-118-7
1085-98-9
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
202-564-5
97-17-6
Acute Tox. 4
214-787-5
1194-65-6
Acute Tox. 4
217-635-6
1918-00-9
Acute Tox. 4; Eye Dam. 1
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
201-557-4
84-74-2
Repr. 1B
yes
200-824-2
74-95-3
Acute Tox. 4
215-125-8
1303-86-2
Repr. 1B
yes
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
205-886-4
191-30-0
Carc. 1B; Muta. 2
205-878-0
189-64-0
Carc. 1B; Muta. 2
200-181-8
53-70-3
Carc. 1B
206-382-7
334-88-3
Carc. 1B
206-373-8
333-41-5
Acute Tox. 4
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
237-499-1
13820-41-2
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
240-973-0
16919-58-7
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
422-670-7
150202-11-2
Repr. 2; Acute Tox. 3; STOT RE 2
GENIPLEX A
401-610-3
122012-52-6
Acute Tox. 4; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
234-454-8
12004-35-2
Carc. 1A; STOT RE 1; Skin Sens. 1
205-016-3
131-17-9
Acute Tox. 4
233-689-3
10311-84-9
Acute Tox. 2; Acute Tox. 3
203-733-6
110-05-4
Org. Perox. E; Flam. Liq. 2; Muta. 2
CM 26-137
406-052-4
125078-60-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
205-017-9
131-18-0
Repr. 1B
yes
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
203-921-8
111-92-2
Flam. Liq. 3; Acute Tox. 4
205-575-3
142-96-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
950-299-5
-
yes
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
204-424-9
120-78-5
Skin Sens. 1
213-800-1
1014-69-3
Acute Tox. 4
237-198-5
13684-56-5
Repr. 2
-
-
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.
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
213-052-6
919-86-8
Acute Tox. 3

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