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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 lipnja 2024. Database contains 4821 unique substances/entries.
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202-436-9
95-63-6
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-433-2
95-57-8
Acute Tox. 4
202-431-1
95-55-6
Muta. 2; Acute Tox. 4
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
202-425-9
95-50-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-424-3
95-49-8
Acute Tox. 4
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
202-422-2
95-47-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
202-411-2
95-33-0
Skin Sens. 1
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
427-110-5
948991-29-5
Acute Tox. 4; STOT RE 2
A complex combination of hydrocarbons obtained by solvent deparaffination of the hydrogenated raffinate obtained by solvent extraction of a hydrotreated petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-595-3
94733-16-1
Carc. 1B
A complex combination of hydrocarbons obtained by solvent deparaffination of the distillation residue from hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-594-8
94733-15-0
Carc. 1B
A complex combination of hydrocarbons obtained by solvent dearomatization of the residue of hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).
305-589-0
94733-09-2
Carc. 1B
305-588-5
94733-08-1
Carc. 1B
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
213-423-2
947-02-4
Acute Tox. 1; Acute Tox. 2
807-366-8
946578-00-3
Acute Tox. 4
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
PIGMENTGELB 82 897
400-710-4
94612-72-3
Acute Tox. 4
Substance obtained as a powdery cathodic precipitate during the electrolytic decoppering stage of copper refining electrolysis. Consists primarily of copper with antimony, arsenic, lead and nickel in metallic form as well as oxides and sulfates.
305-433-1
94551-87-8
Carc. 1A; Muta. 2; Repr. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
213-408-0
944-22-9
Acute Tox. 1; Acute Tox. 2
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
PLINYL ACETATE
424-070-0
94346-09-5
Skin Irrit. 2
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
428-100-3
94239-04-0
Flam. Liq. 3; Acute Tox. 4
619-000-2
94125-34-5
Acute Tox. 4
Diesel engine fuel produced by the hydrogenation of the middle distillate fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 200°C to 280°C (392°F to 536°F). Composed primarily of hydrogenated two-ring hydrocarbons and their alkyl derivatives having carbon numbers predominantly in the range of C11 through C14.
302-695-9
94114-59-7
Carc. 2
Jet engine fuel produced by hydrogenation of the middle distillate fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 225°C (356°F to 473°F). Composed primarily of hydrogenated two-ring hydrocarbons and their alkyl derivatives having carbon numbers predominantly in the range of C10 through C12.
302-694-3
94114-58-6
Carc. 2
Distillate from the hydrogenation of hydrocracked middle distillate from coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 280°C (356°F to 536°F). Composed primarily of hydrogenated two- ring carbon compounds and their alkyl derivatives having carbon numbers predominantly in the range of C9 through C14.
302-693-8
94114-57-5
Carc. 1B; Muta. 1B
Distillate obtained from the hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 180°C to 300°C (356°F to 572°F. Composed primarily of two-ring aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes having carbon numbers predominantly in the range of C9 through C14. Nitrogen, sulfur and oxygen-containing compounds are also present.
302-692-2
94114-56-4
Carc. 1B; Muta. 1B
Motor fuel produced by the reforming of the refined naphtha fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 180°C (86°F to 356°F). Composed primarily of aromatic and naphthenic hydrocarbons, their alkyl derivatives and alkyl hydrocarbons having carbon numbers in the range of C4 through C9.
302-691-7
94114-55-3
Carc. 1B
Fraction of the distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 180°C (86°F to 356°F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 to C9. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.
302-690-1
94114-54-2
Carc. 1B; Muta. 1B
Distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 300°C (86°F to 572°F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 through C14. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.
302-689-6
94114-53-1
Carc. 1B; Muta. 1B
The liquid product of condensation of vapors emitted during the digestion of coal in a liquid solvent and boiling in the range of approximately 30°C to 300°C (86°F to 572°F). Composed primarily of partly hydrogenated condensed-ring aromatic hydrocarbons, aromatic compounds containing nitrogen, oxygen and sulfur, and their alkyl derivatives having carbon numbers predominantly in the range of C4 through C14.
302-688-0
94114-52-0
Carc. 1B; Muta. 1B
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
A cohesive powder composed of coal mineral matter and undissolved coal remaining after extraction of coal by a liquid solvent.
302-681-2
94114-46-2
Carc. 1B
The distillate from lignite tar boiling in the range of approximately 80°C to 250°C (176°F to 482°F). Composed primarily of aliphatic and aromatic hydrocarbons and monobasic phenols.
302-674-4
94114-40-6
Carc. 1B; Muta. 1B
The distillate from the acidification of alkaline washed lignite tar distillate boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Composed primarily of m- and p-ethylphenol as well as cresols and xylenols.
302-662-9
94114-29-1
Carc. 1B; Muta. 1B
The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140° to 170°C (284°F to 392°F) according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.
302-650-3
94114-13-3
Carc. 1B
A distillation fraction from the hydrogenation of pyrolysis gasoline boiling in the range of approximately 20°C to 200°C (68°F to 392°F).
302-639-3
94114-03-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
NCC ETHER
406-100-4
94097-88-8
Skin Sens. 1
D-HPPA; HPOPS
407-960-3
94050-90-5
Eye Dam. 1
ACC ETHER
405-260-2
94050-51-8
Acute Tox. 4; Skin Sens. 1
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
202-377-9
94-96-2
Eye Dam. 1
202-366-9
94-82-6
Acute Tox. 4
202-361-1
94-75-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1; Skin Sens. 1

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