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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 svibnja 2024. Database contains 4821 unique substances/entries.
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203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
229-851-8
6786-83-0
yes
201-254-7
80-15-9
Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-635-0
98-08-8
Flam. Liq. 2
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
226-009-1
5216-25-1
Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
605-037-1
156052-68-5
Skin Sens. 1
231-176-9
7440-67-7
Water-react. 1; Pyr. Sol. 1
231-176-9
7440-67-7
Self-heat. 1
936-037-2
-
yes
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
417-130-2
1379689-21-0
Eye Dam. 1
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
231-793-3
7733-02-0
Acute Tox. 4; Eye Dam. 1
231-175-3
7440-66-6
Water-react. 1; Pyr. Sol. 1
425-240-7
-
Eye Dam. 1
show/hide
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
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-
Carc. 1A; Acute Tox. 4; Skin Sens. 1
231-592-0
7646-85-7
Acute Tox. 4; Skin Corr. 1B
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Z-6
402-280-3
149144-82-1
Eye Irrit. 2; Skin Irrit. 2
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
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.
-
-
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.
219-364-9
2425-10-7
Acute Tox. 4
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
607-955-8
2655-14-3
Acute Tox. 4
-
-
P Parasites
-
-
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.
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
-
-
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.
-
-
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.
-
-
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.
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 1B
201-377-6
81-81-2
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
200-831-0
75-01-4
Press. Gas; Flam. Gas 1; Carc. 1A
203-545-4
108-05-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3
256-599-6
50471-44-8
Carc. 2; Repr. 1B; Skin Sens. 1
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
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.
217-681-7
1929-77-7
Acute Tox. 4
-
-
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.
-
-
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.
-
-
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.
BTN; VPO CATALYST
406-260-5
58834-75-6
Eye Irrit. 2; Skin Sens. 1
424-390-0
93280-40-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1
218-894-8
2275-23-2
Acute Tox. 3; Acute Tox. 4
D,L-VALINEAMIDE
402-840-7
20108-78-5
Repr. 2; Eye Irrit. 2; Skin Sens. 1
203-677-2
109-52-4
Skin Corr. 1B
-
-
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.
ITC 826 CONCENTRATE
422-720-8
166242-53-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
200-123-1
51-79-6
Carc. 1B
show/hide
Tetrakis(pentane-2,4-dionato-O,O')uranium EC / List no: 265-498-6 | CAS no: 65137-03-3
Bis(nitrato-O,O')dioxouranium EC / List no: 253-053-9 | CAS no: 36478-76-9
Dioxobis(pentane-2,4-dionato-O,O')uranium EC / List no: 241-951-3 | CAS no: 18039-69-5
Dipotassium heptaoxodiuranate EC / List no: 232-217-3 | CAS no: 7790-63-8
Nitric acid, uranium salt EC / List no: - | CAS no: 15905-86-9
Bis(formato-O)dioxouranium EC / List no: 241-063-6 | CAS no: 16984-59-1
Bis(nitrato-O)dioxouranium EC / List no: 233-266-3 | CAS no: 10102-06-4
Uranium disulphide EC / List no: 234-884-6 | CAS no: 12039-14-4
Uranium trioxide EC / List no: 215-701-9 | CAS no: 1344-58-7
[oxalato(2-)-O,O']dioxouranium EC / List no: 217-986-5 | CAS no: 2031-89-2
Resin acids and Rosin acids, uranyl salts EC / List no: 273-325-0 | CAS no: 68956-97-8
Hydrogen dioxo[phosphato(3-)-O,O']uranate(1-) EC / List no: 242-306-9 | CAS no: 18433-48-2
Sodium tris(benzeneacetato-O)dioxouranate(1-) EC / List no: 309-040-6 | CAS no: 99800-13-2
polysilicate EC / List no: - | CAS no: 12427-14-4
Difluorodioxouranium EC / List no: 236-898-8 | CAS no: 13536-84-0
Dichlorodioxouranium EC / List no: 232-246-1 | CAS no: 7791-26-6
Nitric acid, uranium(6+) salt EC / List no: - | CAS no: 20820-60-4
Dipotassium uranyl bis(sulphate), of uranium depleted in uranium-235 EC / List no: 262-284-4 | CAS no: 60542-74-7
Uranium hexafluoride EC / List no: 232-028-6 | CAS no: 7783-81-5
Uranium nitride EC / List no: - | CAS no: 12058-37-6
Triuranium octaoxide EC / List no: 215-702-4 | CAS no: 1344-59-8
Oxobis(pentane-2,4-dionato-O,O')uranium EC / List no: 254-311-3 | CAS no: 39136-40-8
Uranium tetrabromide EC / List no: 236-734-5 | CAS no: 13470-20-7
Dioxo[sulphato(2-)-O]uranium EC / List no: 215-240-3 | CAS no: 1314-64-3
Magnesium uranium(4+) hexaacetate EC / List no: 243-905-8 | CAS no: 20596-93-4
Uranium tetraiodide EC / List no: 236-735-0 | CAS no: 13470-22-9
Bis(acetato-O)dioxouranium EC / List no: 208-767-5 | CAS no: 541-09-3
Uranium diselenide EC / List no: 235-245-4 | CAS no: 12138-21-5
Uranium dioxideperoxide EC / List no: 234-852-1 | CAS no: 12036-71-4
Uranium carbide (UC2) EC / List no: - | CAS no: 12071-33-9
Uranium pentafluoride EC / List no: 237-405-9 | CAS no: 13775-07-0
Lead uranate pigment EC / List no: 287-565-9 | CAS no: 85536-79-4
Uranium trifluoride EC / List no: 237-404-3 | CAS no: 13775-06-9
Uranium disilicide EC / List no: 234-906-4 | CAS no: 12039-85-9
Zinc tetrakis(acetato-O)dioxouranate EC / List no: 251-762-8 | CAS no: 33959-50-1
Uranium nitrate EC / List no: - | CAS no: 13826-82-9
Calcium diuranium heptaoxide EC / List no: 237-428-4 | CAS no: 13780-21-7
Calcines, uranium ore-conc.
Calcined precipitates of ammonium, magnesium or sodium uranates obtained from natural uranium ores.
EC / List no: 297-819-0 | CAS no: 93763-02-1
Uranium triiodide EC / List no: 237-406-4 | CAS no: 13775-18-3
Uranium hydride EC / List no: 257-346-2 | CAS no: 51680-55-8
Uranium ditelluride EC / List no: 235-249-6 | CAS no: 12138-37-3
Zinc bis(acetato-O)dioxouranate EC / List no: 233-390-8 | CAS no: 10138-94-0
Nasturan EC / List no: 690-098-7 | CAS no: 1317-99-3
Uranium carbide (UC) EC / List no: - | CAS no: 12070-09-6
Uranyl acetate-2H2O EC / List no: 629-550-5 | CAS no: 6159-44-0
Uranium tetrafluoride EC / List no: 233-170-1 | CAS no: 10049-14-6
Uranium hydride (UH3) EC / List no: - | CAS no: 13598-56-6
Titanate(4-), oxobis[phosphato(3-)]-, barium (1:2), uranium-doped EC / List no: 309-550-9 | CAS no: 100403-10-9
Disodium heptaoxodiuranate, of uranium depleted in uranium-235 EC / List no: 237-286-3 | CAS no: 13721-34-1
Tetraammonium uranyl tricarbonate, of uranium depleted in uranium-235 EC / List no: 241-988-5 | CAS no: 18077-77-5
Acetic acid, uranium(4+) zinc salt EC / List no: 243-904-2 | CAS no: 20596-91-2
Sodium uranyl triacetate, of uranium depleted in uranium-235 EC / List no: 241-714-4 | CAS no: 17712-38-8
Nickel triuranium decaoxide EC / List no: 239-876-6 | CAS no: 15780-33-3
Uranium fluoride (U2F9) EC / List no: - | CAS no: 12134-48-4
Uranium dioxide EC / List no: 215-700-3 | CAS no: 1344-57-6
Disodium uranium tetraoxide EC / List no: 236-846-4 | CAS no: 13510-99-1
Diammonium diuranium heptaoxide EC / List no: 231-986-2 | CAS no: 7783-22-4
Bis(2-ethylhexanoato-O)dioxouranium EC / List no: 267-849-9 | CAS no: 67939-77-9
Uranium tetraboride EC / List no: 234-520-6 | CAS no: 12007-84-0
Uranium diboride EC / List no: 234-508-0 | CAS no: 12007-36-2
Uranium tetrachloride EC / List no: 233-057-7 | CAS no: 10026-10-5
Uranium EC / List no: 231-170-6 | CAS no: 7440-61-1
Magnesium diuranium heptaoxide EC / List no: 236-982-4 | CAS no: 13568-61-1
Nickel uranyl tetraacetate, of uranium depleted in uranium-235 EC / List no: 275-994-4 | CAS no: 71767-12-9
Triuranium tetraphosphide EC / List no: 234-871-5 | CAS no: 12037-84-2
Barium uranium oxide EC / List no: - | CAS no: 10380-31-1
-
-
Acute Tox. 2; STOT RE 2
231-170-6
7440-61-1
Acute Tox. 2; STOT RE 2
Any of the volatile predominately terpenic fractions or distillates resulting from the solvent extraction of, gum collection from, or pulping of softwoods. Composed primarily of the C10H16 terpene hydrocarbons: α-pinene, β-pinene, limonene, 3-carene, camphene. May contain other acyclic, monocyclic, or bicyclic terpenes, oxygenated terpenes, and anethole. Exact composition varies with refining methods and the age, location, and species of the softwood source.
232-350-7
8006-64-2
Flam. Liq. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
232-650-8
9002-07-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
-
-
P Parasites
-
-
P Parasites
-
-
P Parasites
-
-
P Parasites
610-700-3
51580-86-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
220-767-7
2893-78-9
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
218-828-8
2244-21-5
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
246-677-8
25155-23-1
Repr. 1B
yes
604-291-0
142469-14-5
Skin Sens. 1
-
138182-18-0
Repr. 2; STOT RE 2
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
238-253-6
14312-40-4
yes
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
422-090-4
172737-80-3
Eye Dam. 1
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
TRILON(R) ES 9910
414-130-4
119710-96-2
Acute Tox. 4
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
RED JB 747
418-220-4
-
Skin Sens. 1
BI 3277; NOIR CORSE SANODAL H3LW CONC.; SANODAL DEEP BLACK H-3LW CONC.; SANODAL TIEFSCHWARZ H-3LW; SANODAL TIEFSCHWARZ H-3LW KONZ.
400-810-8
106084-79-1
Muta. 2
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
TURQUOISE 10 40 518
411-430-7
-
Eye Dam. 1; Skin Sens. 1
423-100-1
-
Eye Dam. 1
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
440-480-2
341026-59-3
Eye Dam. 1; Skin Sens. 1
430-280-3
844491-96-9
Skin Sens. 1
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1

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