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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
418-410-7
139122-78-4
Eye Irrit. 2
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
425-460-3
1379676-84-2
Skin Sens. 1
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
215-185-5
1310-73-2
Skin Corr. 1A
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
239-172-9
15120-21-5
yes
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
435-350-7
141250-43-3
Eye Dam. 1
233-267-9
10102-18-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
A complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235°C to 290°C (455°F to 554°F).
309-881-9
101316-80-7
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180°C to 240°C (356°F to 464°F).
309-882-4
101316-81-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175°C to 220°C (347°F to 428°F).
309-884-5
101316-82-9
Asp. Tox. 1
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
-
13451-08-6
Skin Corr. 1B
626-360-4
15244-35-6
yes
An acidified alkaline extract of brown coal tar distillate. Composed primarily of phenol and phenol homologs.
309-888-7
101316-86-3
Carc. 1B; Muta. 1B
An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivatives, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150°C to 360°C (302°F to 680°F).
309-885-0
101316-83-0
Carc. 1A
A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160°C to 340°C (320°F to 644°F).
309-889-2
101316-87-4
Carc. 1B; Muta. 1B
A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.
309-886-6
101316-84-1
Carc. 1A
Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.
309-726-5
100684-51-3
Carc. 1B
Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300°C (572°F). Composed primarily of aromatic compounds.
309-887-1
101316-85-2
Carc. 1B
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
604-715-4
149979-41-9
Carc. 2; Repr. 2
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1

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