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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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271-635-0
68603-08-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately minus 10°C to 230°C (14°F to 446°F).
265-089-2
64741-87-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
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
The residue remaining from the distillation of recovered naphtha. Composed primarily of naphthalene and condensation products of indene and styrene.
292-636-2
90641-12-6
Carc. 1B; Muta. 1B
206-098-3
300-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
205-547-0
142-59-6
Acute Tox. 4; STOT SE 3; Skin Sens. 1
218-130-3
2051-79-8
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
426-150-0
121246-28-4
Skin Sens. 1
688-331-2
874967-67-6
Carc. 2
-
-
Repr. 1B
431-060-1
153719-38-1
Acute Tox. 4; Skin Sens. 1
204-624-6
123-39-7
Repr. 1B; Acute Tox. 4
424-460-0
283167-56-6
Acute Tox. 4; Skin Sens. 1
202-870-9
100-61-8
Acute Tox. 3; STOT RE 2
201-182-6
79-16-3
Repr. 1B
yes
210-769-6
623-08-5
Acute Tox. 3; STOT RE 2
210-260-9
611-21-2
Acute Tox. 3; STOT RE 2
429-340-1
186295-11-4
Acute Tox. 4; Eye Dam. 1
207-531-9
479-45-8
Expl. 1.1; Acute Tox. 3; STOT RE 2
211-795-0
696-44-6
Acute Tox. 3; STOT RE 2
N-METHYL-4-(P-FORMYLSTYRYL)-PYRIDINIUM METHYLSULFATE; SBQ; SBQ-SALZ
418-240-3
74401-04-0
Skin Sens. 1
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
817-852-1
1228284-64-7
Carc. 2; Repr. 2
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
N-HEXYLLITHIUM
404-950-0
21369-64-2
Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
DTBA
401-980-6
-
Skin Irrit. 2; Skin Sens. 1
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
CATALYST 4017
407-780-5
4186-71-4
Acute Tox. 4
437-720-3
227085-51-0
Eye Dam. 1
220-250-6
2687-91-4
Repr. 1B
DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE
421-130-8
156679-41-3
Eye Dam. 1; Skin Sens. 1
202-411-2
95-33-0
Skin Sens. 1
PREVENTOL VP OC 3061
423-990-1
149118-66-1
Acute Tox. 4; Eye Dam. 1
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
DISPERSOL YELLOW XF
407-970-8
75511-91-0
Skin Sens. 1
EP 389
407-730-2
104958-67-0
Eye Irrit. 2; Skin Sens. 1
209-669-5
590-01-2
Flam. Liq. 3
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
425-300-2
186450-73-7
Skin Sens. 1
429-120-5
208535-04-0
Eye Dam. 1
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
427-880-2
90357-53-2
STOT RE 2
BENZANILID-DISPERSE-INTERMEDIATE ZP 9955
411-590-8
70693-57-1
Skin Corr. 1B
423-530-8
152828-23-4
STOT RE 1; Acute Tox. 4
DS 100
415-060-7
1379678-87-1
Eye Dam. 1; Skin Sens. 1
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1

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