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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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620-425-0
68049-83-2
Repr. 1B; STOT RE 2
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
211-653-8
680-31-9
Carc. 1B; Muta. 1B
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
200-677-4
68-11-1
Acute Tox. 3; Skin Corr. 1B
267-897-0
67952-43-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
The complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This lower boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C5. This stream may contain benzene.
267-565-5
67891-80-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
The complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This higher boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having carbon number predominantly of C5. This stream may contain benzene.
267-563-4
67891-79-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
229-851-8
6786-83-0
yes
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
266-994-5
67747-09-5
Acute Tox. 4
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
LUPEROX 533
403-320-2
67567-23-1
Org. Perox. D; Flam. Liq. 3
266-719-9
67564-91-4
Repr. 2; Acute Tox. 4; Skin Irrit. 2
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
425-430-1
6746-94-7
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
211-617-1
674-82-8
Flam. Liq. 3; Acute Tox. 4
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3
266-583-0
67129-08-2
Skin Sens. 1B; Carc. 2
266-578-3
67118-55-2
yes
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
200-663-8
67-66-3
Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-661-7
67-63-0
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-659-6
67-56-1
Flam. Liq. 2; Acute Tox. 3; STOT SE 1
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
T 1569; T001569
423-290-4
66938-41-8
Muta. 2
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
LU20
405-450-5
66531-87-1
Skin Sens. 1
266-362-9
66441-23-4
Skin Sens. 1
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
613-911-9
66230-04-4
Acute Tox. 3; STOT SE 1; STOT RE 2; Skin Sens. 1
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
200-629-2
66-71-7
Acute Tox. 3
200-628-7
66-56-8
Acute Tox. 3; STOT RE 2
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
The distillate from coal tar having an approximate distillation range of 100°C to 450°C (212°F to 842°F). Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.
266-027-7
65996-92-1
Carc. 1B
The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.
266-026-1
65996-91-0
Carc. 1B
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.
266-025-6
65996-90-9
Carc. 1A
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
266-024-0
65996-89-6
Carc. 1A
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
The residue obtained from coal tar oil by an alkaline wash such as aqueous sodium hydroxide after the removal of crude coal tar acids. Composed primarily of naphthalenes and aromatic nitrogen bases.
266-021-4
65996-87-4
Carc. 1B; Muta. 1B
The extract from coal tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.
266-020-9
65996-86-3
Carc. 1B; Muta. 1B

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