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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
Filter the list

617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
201-898-9
89-32-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
SQ 28,355; SQ 28355
416-050-5
87460-09-1
Eye Dam. 1
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
280-084-5
82985-35-1
Eye Dam. 1
U 9649
401-380-4
89066-61-5
Eye Irrit. 2
INTEROX-PMBP-70W; INTEROX-PMPB-70W
407-950-9
895-85-2
Org. Perox. B
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
616-932-1
8011-63-0
Acute Tox. 4; Eye Dam. 1
620-359-2
8065-36-9
Acute Tox. 3
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
232-283-3
8001-35-2
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
201-599-3
85-34-7
Acute Tox. 4
201-246-3
80-06-8
Acute Tox. 4
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
282-714-4
84332-86-5
Carc. 2
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
ARGOLD; CINMETHYLIN; WL 95481
402-410-9
87818-31-3
Acute Tox. 4
617-258-0
81777-89-1
Acute Tox. 4
201-378-1
81-82-3
STOT RE 2
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
201-248-4
80-08-0
Acute Tox. 4
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
212-758-1
867-27-6
Acute Tox. 3
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
201-557-4
84-74-2
Repr. 1B
yes
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-559-5
84-75-3
Repr. 1B
yes
201-553-2
84-69-5
Repr. 1B
yes
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
yes
201-434-5
82-66-6
Acute Tox. 2; STOT RE 1
-
83-59-0
Acute Tox. 3; Acute Tox. 4
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
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
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
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150°C to 210°C (302°F to 410°F).
283-483-2
84650-03-3
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by crystallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.
284-898-1
84989-09-3
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills in the approximate range of 200°C to 250°C (392°F to 482°F).
283-484-8
84650-04-4
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.
284-899-7
84989-10-6
Carc. 1B
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from coal tar. It consists of aromatic and polycyclic hydrocarbons, primarily fluorene and acenaphthene.
284-900-0
84989-11-7
Carc. 1B
The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148°C (298°F).
285-076-5
85029-51-2
Carc. 1B; Muta. 1B
A complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 160°C to 180°C (320°F to 356°F).
285-509-8
85116-58-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to C25 and boiling in the range of approximately 205° C to 400°C (401°F to 752°F).
285-505-6
85116-53-6
Carc. 1B
CA 875 B
414-450-4
88805-65-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ETHOFENPROX; TREBON
407-980-2
80844-07-1
Lact.
CINEOLE ALCOHOL
402-470-6
87172-89-2
Acute Tox. 4; Eye Dam. 1
The extract oil boiling in the range of approximately 220°C to 265°C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.
284-901-6
84989-12-8
Carc. 1B; Muta. 1B
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
A complex combination of hydrocarbons obtained by hydrodesulfurization of heavy coker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range C18 to C44 and boiling in the range of approximately 304°C to 548°C (579°F to 1018° F). Likely to contain 5% or more of 4- to 6- membered condensed ring aromatic hydrocarbons.
285-555-9
85117-03-9
Carc. 1B
A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 20°C to 120°C (-4°F to 248°F).
232-349-1
8006-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30°C to 260°C (86°F to 500°F).
289-220-8
86290-81-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
617-243-9
81591-81-3
Acute Tox. 4
HALOXYFOP ETHOXYETHYL EST
402-560-5
87237-48-7
Acute Tox. 4
212-485-8
822-06-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
BRUN REACTIF 45; BRUNO REATTIVO 45; C.I. REACTIVE BROWN 45; CIBACROM BROWN 1347; CIBACRON BROWN 1347; REACTIVE BRAUN 45
401-650-1
85665-96-9
Skin Sens. 1
289-339-5
87741-01-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
617-219-8
81334-34-1
Eye Irrit. 2
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons predominantly in the range of C8 to C16 and boiling in the range of approximately 120°C to 283°C (284°F to 541°F).
285-507-7
85116-55-8
Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 150°C to 290°C (320°F to 554°F).
232-366-4
8008-20-6
Asp. Tox. 1
SP 807
420-150-4
80498-15-3
Resp. Sens. 1
A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20°C to 135°C (58°F to 275°F).
232-453-7
8032-32-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
212-737-7
865-34-9
Self-heat. 1; Skin Corr. 1B
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
432-350-9
81752-87-6
Skin Irrit. 2
442-860-3
87333-22-0
Skin Sens. 1
201-297-1
80-62-6
Flam. Liq. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
F5384
401-340-6
83055-99-6
Skin Sens. 1
201-328-9
81-14-1
Carc. 2
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
688-331-2
874967-67-6
Carc. 2
A complex combination of hydrocarbons produced by fractionation from catalytically reformed hydrodesulfurized naphtha. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 to C13 and boiling in the range of approximately 98°C to 218°C (208°F to 424°F).
285-508-2
85116-57-0
Asp. Tox. 1
A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66°C to 121°C (151°F to 250°F).
285-510-3
85116-59-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by fractionation of hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23°C to 195°C (73°F to 383°F).
285-511-9
85116-60-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the distillation of a petroleum fraction. It consists predominantly of alkanes and cycloalkanes boiling in the range of approximately minus 20°C to 190°C (-4°F to 374°F).
285-512-4
85116-61-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Refined, partly refined, or unrefined petroleum products produced by the distillation of natural gas. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 100°C to 200°C (212°F to 392°F).
232-443-2
8030-30-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
284-349-6
84852-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-468-1
85508-43-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-469-7
85508-44-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
201-855-4
88-74-4
Acute Tox. 3; STOT RE 2
201-280-9
80-46-6
yes
287-196-3
85422-92-0
yes
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.
285-098-5
85029-74-9
Carc. 1B
A complex combination of hydrocarbons obtained as a semi-solid from dewaxing paraffinic residual oil. It consists predominantly of saturated crystalline and liquid hydrocarbons having carbon numbers predominantly greater than C25.
232-373-2
8009-03-8
Carc. 1B
A complex combination of hydrocarbons. It consists predominantly of aliphatic, alicyclic and aromatic hydrocarbons. It may also contain small amounts of nitrogen, oxygen and sulfur compounds. This category encompasses light, medium, and heavy petroleums, as well as the oils extracted from tar sands. Hydrocarbonaceous materials requiring major chemical changes for their recovery or conversion to petroleum refinery feedstocks such as crude shale oils, upgraded shale oils and liquid coal fuels are not included in this definition.
232-298-5
8002-05-9
Carc. 1B

Export search results to: