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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 lipnja 2024. Database contains 4821 unique substances/entries.
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429-370-5
220410-74-2
Acute Tox. 4
218-817-8
2243-62-1
Carc. 2
433-580-2
214353-17-0
Carc. 1B; Acute Tox. 4; Skin Corr. 1B
433-580-2
214353-17-0
Acute Tox. 4; Skin Corr. 1B
246-011-6
24083-03-2
Acute Tox. 4
GOLPANOL APC
412-740-5
25965-81-5
Acute Tox. 4; Skin Sens. 1
4-(4-ETHYLCYCLOHEXYL)-ACETOPHENON
426-460-6
260415-81-4
Skin Sens. 1
429-040-0
272460-97-6
Eye Dam. 1
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
O-NITROBENZALDEHYDDIMETHYLACETAL
423-830-9
20627-73-0
Skin Sens. 1
SURFADONE LP-300 SURFACTANT
403-730-1
2687-96-9
Skin Corr. 1B; Skin Sens. 1
219-989-7
2592-95-2
Expl. 1.3
432-840-2
220926-97-6
Acute Tox. 4
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
218-741-5
2223-82-7
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
218-173-8
2062-98-8
yes
219-397-9
2431-50-7
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
218-645-3
2210-79-9
Muta. 2; Skin Irrit. 2; Skin Sens. 1
246-690-9
25167-70-8
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
-
21436-97-5
Carc. 1B; Acute Tox. 3
218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
424-870-1
27624-67-5
Expl. 1.1; Eye Dam. 1
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
AZOGELB
421-430-9
28365-08-4
Acute Tox. 4; STOT RE 2
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
247-384-8
25973-55-1
yes
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
M-TMI
402-440-2
2094-99-7
Acute Tox. 2; Skin Corr. 1B; STOT RE 2; Resp. Sens. 1; Skin Sens. 1
443-980-9
221215-20-9
Skin Sens. 1
220-548-6
2807-30-9
Acute Tox. 4; Eye Irrit. 2
243-816-4
20427-84-3
yes
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
DEBROPOL
407-030-7
24403-04-1
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
426-540-0
2973-59-3
Skin Sens. 1
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
POLLENAL II
412-270-0
2109-22-0
Skin Sens. 1
220-688-8
2867-47-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
219-449-0
2438-20-2
Flam. Liq. 3
220-239-6
2682-20-4
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
248-743-1
27942-27-4
yes
219-682-8
2497-59-8
yes
247-816-5
26571-11-9
yes
431-500-0
226065-73-2
Skin Sens. 1
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
220-630-1
2840-00-8
Acute Tox. 4
218-951-7
2300-66-5
Eye Irrit. 2
606-640-2
2079-00-7
Acute Tox. 2
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
220-666-8
2855-13-2
Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
220-426-2
2761-09-3
Eye Irrit. 2; Skin Sens. 1
-
2532-43-6
Acute Tox. 3
432-530-7
24294-01-7
Acute Tox. 4
DMA
407-500-1
21983-80-2
Skin Sens. 1
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
621-341-7
2315-61-9
yes
426-900-7
203118-12-1
STOT SE 3
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
RO 827
412-090-2
2788-74-1
Acute Tox. 4; Skin Sens. 1
430-840-7
202483-63-4
Skin Sens. 1
608-055-8
27147-75-7;27459-10-5
yes
608-055-8
27147-75-7;27459-10-5
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
621-345-9
2315-67-5
yes
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
421-940-1
28698-31-9
Eye Dam. 1
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
219-943-6
2580-56-5
yes
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
217-990-7
2032-59-9
Acute Tox. 3
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
220-147-6
2642-71-9
Acute Tox. 2; Acute Tox. 3
244-214-4
21109-95-5
Acute Tox. 4
245-216-8
22781-23-3
Acute Tox. 3; Acute Tox. 2
246-585-8
25057-89-0
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
205-911-9
205-99-2
Carc. 1B

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