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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 srpnja 2024. Database contains 4821 unique substances/entries.
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201-280-9
80-46-6
yes
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
201-254-7
80-15-9
Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
201-248-4
80-08-0
Acute Tox. 4
201-246-3
80-06-8
Acute Tox. 4
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
[S]-2-INDOLINE CARBOXYLIC ACID
410-860-2
79815-20-6
Repr. 2; STOT RE 2; Skin Sens. 1
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 2
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
SERTRALINE STEP 2
420-560-3
79617-97-3
Eye Dam. 1
428-230-0
79568-06-2
STOT RE 2
616-699-6
79538-32-2
Acute Tox. 1; Acute Tox. 2
427-300-8
79463-77-7
Eye Dam. 1
ACTF; P-007
401-670-0
79456-26-1
Acute Tox. 4
F7641; MTSI
410-550-7
79277-18-2
STOT RE 2; Resp. Sens. 1; Skin Sens. 1
616-669-2
79241-46-6
Repr. 2
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
1418U90
418-530-1
79200-56-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-207-0
79-43-6
Skin Corr. 1A
201-204-4
79-41-4
Acute Tox. 4; Skin Corr. 1A
201-199-9
79-36-7
Skin Corr. 1A
201-197-8
79-34-5
Acute Tox. 2; Acute Tox. 1
201-196-2
79-33-4
Skin Corr. 1C; Eye Dam. 1
201-195-7
79-31-2
Acute Tox. 4
201-194-1
79-30-1
Flam. Liq. 2; Skin Corr. 1A
201-193-6
79-29-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
201-191-5
79-27-6
Acute Tox. 2; Eye Irrit. 2
201-188-9
79-24-3
Flam. Liq. 3; Acute Tox. 4
201-187-3
79-22-1
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
201-185-2
79-20-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
201-182-6
79-16-3
Repr. 1B
yes
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
201-176-3
79-09-4
Skin Corr. 1B
201-175-8
79-08-3
Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
201-170-0
79-03-8
Flam. Liq. 2; Skin Corr. 1B
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
201-166-9
79-00-5
Carc. 2; Acute Tox. 4
GR138766X
415-670-3
78850-37-0
Eye Dam. 1
212-324-1
786-19-6
Acute Tox. 3
4-(4-PROPYLCYCLOHEXYL)-ACETOPHENON
406-700-6
78531-61-0
Skin Sens. 1
4'-(4-HEPTYLCYCLOHEXYL)ACETOPHENONE
426-820-2
78531-60-9
Skin Sens. 1
4'-(4-PENTYLCYCLOHEXYL)ACETOPHENONE
426-830-7
78531-59-6
Skin Sens. 1
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
T001769
419-290-9
780757-44-0
Skin Sens. 1
616-584-0
7803-57-8
yes
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
232-259-2
7803-49-8
Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
232-259-2
7803-49-8
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
201-162-7
78-96-6
Skin Corr. 1B
201-159-0
78-93-3
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
201-153-8
78-88-6
Flam. Liq. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
201-152-2
78-87-5
Flam. Liq. 2; Carc. 1B; Acute Tox. 4
201-148-0
78-83-1
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
201-143-3
78-79-5
Flam. Liq. 1; Carc. 1B; Muta. 2
201-142-8
78-78-4
Flam. Liq. 1; Asp. Tox. 1; STOT SE 3
201-134-4
78-70-6
Skin Sens. 1B
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-123-4
78-57-9
Acute Tox. 4
201-114-5
78-40-0
Acute Tox. 4
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
201-084-3
78-11-5
Unst. Expl.
201-084-3
78-11-5
Expl. 1.1
201-083-8
78-10-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-075-4
78-00-2
yes
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
616-572-5
7790-84-3
yes
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
640-998-0
7790-78-5
yes
232-189-2
7789-78-8
Water-react. 1
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
232-151-5
7789-23-3
Acute Tox. 3
232-149-4
7789-21-1
Acute Tox. 4; Skin Corr. 1A
616-541-6
7789-12-0
yes
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
232-104-9
7786-81-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2

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