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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 lipnja 2024. Database contains 4821 unique substances/entries.
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429-240-8
212652-59-0
Eye Dam. 1
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
BLUE TZ 4312
423-770-3
-
Eye Dam. 1
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
BROWN 1612969
407-110-1
480445-87-2
Eye Dam. 1; Skin Sens. 1
237-159-2
13674-87-8
Carc. 2
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
247-759-6
26523-78-4
Skin Sens. 1
yes
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Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
799-976-5
-
yes
213-934-0
1067-53-4
Repr. 1B
yes
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
-
7276-58-6
Acute Tox. 4
-
-
Acute Tox. 3
TRYPROPYLAMMONIUM DIHYDROGENPHOSPHAT
433-700-3
35687-90-2
Acute Tox. 4
-
-
Acute Tox. 3
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-829-6
12035-72-2
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
233-844-5
10381-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
-
-
Acute Tox. 2; Acute Tox. 1
257-765-0
52234-82-9
Muta. 2; Eye Dam. 1; Skin Sens. 1
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4
220-449-8
2768-02-7
Skin Sens. 1B
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
235-252-2
12141-20-7
yes
222-979-5
3687-31-8
yes
231-205-5
7446-27-7
Repr. 1A; STOT RE 2
215-290-6
1319-46-6
yes
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
603-146-9
126535-15-7
Carc. 2
216-428-8
1582-09-8
Carc. 2; Skin Sens. 1
219-014-5
2314-97-8
Muta. 2
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
604-237-6
141517-21-7
Lact.; Skin Sens. 1
215-812-2
1420-06-0
Acute Tox. 4
-
-
Acute Tox. 2; Acute Tox. 1
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
201-114-5
78-40-0
Acute Tox. 4
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
274-462-9
70225-16-0
yes
255-559-5
41814-78-2
Acute Tox. 4
215-548-8
1330-78-5
STOT SE 1
215-548-8
1330-78-5
Acute Tox. 4
206-203-2
307-55-1
yes
222-182-2
3380-34-5
Eye Irrit. 2; Skin Irrit. 2
-
-
P Parasites
-
-
F Fungi
-
-
F Fungi
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
206-326-1
327-98-0
Acute Tox. 2; Acute Tox. 3
213-608-8
993-16-8
Repr. 2
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
208-885-7
545-06-2
Acute Tox. 3
200-902-6
75-79-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-149-3
52-68-6
Acute Tox. 4; Skin Sens. 1
-
-
P Parasites
-
-
Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
245-986-5
24017-47-8
Acute Tox. 3; Acute Tox. 4
-
26766-27-8
Acute Tox. 4
432-270-4
221354-37-6
Repr. 2; STOT RE 2
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
-
-
Pyr. Liq. 1; Skin Corr. 1B
259-537-6
55219-65-3
Repr. 1B; Lact.; Acute Tox. 4
256-103-8
43121-43-3
Acute Tox. 4; Skin Sens. 1
200-875-0
75-50-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-875-0
75-50-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
405-060-5
118712-89-3
Skin Irrit. 2
443-150-6
101226-85-1
Flam. Liq. 3
250-517-2
31218-83-4
Acute Tox. 3
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
231-186-3
7443-52-9
Acute Tox. 4
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1

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