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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 srpnja 2024. Database contains 4821 unique substances/entries.
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220-114-6
2631-40-5
Acute Tox. 4
220-113-0
2631-37-0
Acute Tox. 3
247-570-9
26266-63-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
247-554-1
26259-45-0
Acute Tox. 4; Eye Irrit. 2
435-010-8
26157-73-3
Muta. 2
E.M.A.
406-790-7
26116-56-3
Eye Dam. 1
247-449-0
26087-47-8
Acute Tox. 4
247-430-7
26043-11-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
4-(4-ETHYLCYCLOHEXYL)-ACETOPHENON
426-460-6
260415-81-4
Skin Sens. 1
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
220-012-1
2602-46-2
Carc. 1B; Repr. 2
247-384-8
25973-55-1
yes
219-997-0
2597-03-7
Acute Tox. 4
GOLPANOL APC
412-740-5
25965-81-5
Acute Tox. 4; Skin Sens. 1
219-993-9
2595-54-2
Acute Tox. 3
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
219-989-7
2592-95-2
Expl. 1.3
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
247-278-1
25808-74-6
Repr. 1A; Acute Tox. 4; STOT RE 2
219-943-6
2580-56-5
yes
-
25747-83-5
yes
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
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1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
247-148-4
25637-99-4
Repr. 2; Lact.
yes
247-143-7
25637-27-8
Acute Tox. 4
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
X4261
401-850-9
255881-94-8
yes
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
247-109-1
25567-67-3
Acute Tox. 3; STOT RE 2
247-096-2
25550-58-7
Acute Tox. 3; STOT RE 2
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
432-860-1
255387-46-3
Skin Sens. 1
246-948-0
25402-06-6
Acute Tox. 4
219-818-6
2540-82-1
Acute Tox. 4
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
246-901-4
25366-23-8
Acute Tox. 4
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
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
-
2532-43-6
Acute Tox. 3
246-831-4
25319-90-8
Acute Tox. 4
246-814-1
25311-71-1
Acute Tox. 3
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
440-460-3
252579-81-0
Eye Irrit. 2
500-036-1
25214-70-4
yes
246-698-2
25168-05-2
Acute Tox. 4
246-691-4
25167-80-0
Acute Tox. 4
246-690-9
25167-70-8
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
246-677-8
25155-23-1
Repr. 1B
yes
246-673-6
25154-54-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
219-732-9
2514-53-6
Skin Irrit. 2
423-730-5
250688-43-8
Eye Dam. 1
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
427-930-3
250639-69-1
Skin Sens. 1
246-585-8
25057-89-0
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
219-682-8
2497-59-8
yes
219-679-1
2497-07-6
Acute Tox. 2; Acute Tox. 3
434-290-9
249630-78-2
Acute Tox. 4
246-538-1
24934-91-6
Acute Tox. 1; Acute Tox. 2
219-634-6
2487-01-6
Acute Tox. 3; Acute Tox. 4
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
219-603-7
2475-45-8
Carc. 1B; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
246-376-1
24634-61-5
Eye Irrit. 2
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
425-260-6
244634-31-9
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
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
219-468-4
2439-99-8
Eye Dam. 1
219-459-5
2439-10-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
HWL-158
432-590-4
243869-48-9
Eye Irrit. 2
432-980-4
243858-60-8
Eye Dam. 1
432-550-6
243858-01-7
Eye Dam. 1
219-449-0
2438-20-2
Flam. Liq. 3
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
ISOBUTYLVINYL ACETATE; IVA
401-170-2
24342-03-8
Flam. Liq. 3
219-397-9
2431-50-7
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
246-147-6
24307-26-4
Acute Tox. 4
432-530-7
24294-01-7
Acute Tox. 4
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
219-376-4
2426-08-6
Flam. Liq. 3; Carc. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Sens. 1
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
219-371-7
2425-79-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
219-364-9
2425-10-7
Acute Tox. 4
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
219-348-1
2421-28-5
Eye Irrit. 2; STOT SE 3
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
607-329-4
24151-93-7
Acute Tox. 4
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
246-011-6
24083-03-2
Acute Tox. 4
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
701-312-6
240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
245-986-5
24017-47-8
Acute Tox. 3; Acute Tox. 4
245-951-4
23950-58-5
Carc. 2
245-949-3
23947-60-6
Acute Tox. 4
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
219-196-6
2385-85-5
Carc. 2; Repr. 2; Lact.; Acute Tox. 4
428-340-9
238088-70-5
Skin Irrit. 2
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
245-740-7
23564-05-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Sens. 1
245-737-0
23560-59-0
Acute Tox. 3
245-704-0
23505-41-1
Acute Tox. 3; Acute Tox. 4
245-656-0
23422-53-9
Acute Tox. 2; Skin Sens. 1
621-345-9
2315-67-5
yes
621-341-7
2315-61-9
yes
219-014-5
2314-97-8
Muta. 2
245-445-3
23135-22-0
Acute Tox. 2; Acute Tox. 4
219-007-7
2312-76-7
Acute Tox. 3; STOT RE 2
219-006-1
2312-35-8
Carc. 2; Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1
245-430-1
23103-98-2
Carc. 2; Acute Tox. 3; Skin Sens. 1
218-996-2
2310-17-0
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
B2,4DBB
420-710-8
23085-60-1
Repr. 2; Skin Irrit. 2; Skin Sens. 1
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
218-953-8
2302-17-2
Skin Sens. 1
218-951-7
2300-66-5
Eye Irrit. 2
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
245-216-8
22781-23-3
Acute Tox. 3; Acute Tox. 2
218-894-8
2275-23-2
Acute Tox. 3; Acute Tox. 4
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
218-892-7
2275-14-1
Acute Tox. 3
437-720-3
227085-51-0
Eye Dam. 1
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
431-500-0
226065-73-2
Skin Sens. 1
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
ET 344 SP
412-540-8
22471-55-2
Skin Irrit. 2
R633
406-230-1
224635-63-6
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
-
22454-04-2
yes
218-828-8
2244-21-5
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
218-827-2
2244-16-8
Skin Sens. 1
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
218-817-8
2243-62-1
Carc. 2
TILCOM HTB
411-740-2
22411-22-9
Eye Dam. 1; Skin Sens. 1
244-959-5
22398-80-7
Carc. 1B; Repr. 2; STOT RE 1
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
424-980-8
22288-41-1
Flam. Liq. 2; Org. Perox. D; Skin Irrit. 2; Skin Sens. 1
244-879-0
22259-30-9
Acute Tox. 2; Skin Sens. 1
218-744-1
2223-95-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
218-741-5
2223-82-7
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
244-848-1
22224-92-6
Acute Tox. 2; Eye Irrit. 2
244-845-5
22212-55-1
Acute Tox. 4
432-270-4
221354-37-6
Repr. 2; STOT RE 2
443-980-9
221215-20-9
Skin Sens. 1
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
218-645-3
2210-79-9
Muta. 2; Skin Irrit. 2; Skin Sens. 1
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
432-840-2
220926-97-6
Acute Tox. 4
436-690-9
220727-26-4
Skin Sens. 1
444-440-5
220689-12-3
Acute Tox. 4
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
429-370-5
220410-74-2
Acute Tox. 4
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
DMA
407-500-1
21983-80-2
Skin Sens. 1
244-663-6
21923-23-9
Acute Tox. 2; Acute Tox. 3
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
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
244-578-4
21784-78-1
Carc. 1A; STOT RE 1; Skin Sens. 1
244-544-9
21725-46-2
Acute Tox. 4
218-499-0
2164-08-1
Carc. 2
-
2163-79-3
Acute Tox. 4
244-472-8
21609-90-5
Acute Tox. 3; STOT SE 1; Acute Tox. 4
244-445-0
21564-17-0
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
208-930-0
2155-30-8;547-64-8
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
208-930-0
2155-30-8;547-64-8
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
244-437-7
21548-32-3
Acute Tox. 1; Acute Tox. 2
426-470-0
214897-29-7
Skin Sens. 1
435-860-1
214417-91-1
Skin Sens. 1
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
-
21436-97-5
Carc. 1B; Acute Tox. 3
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
429-570-2
213990-58-0
Skin Sens. 1
N-HEXYLLITHIUM
404-950-0
21369-64-2
Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
433-010-2
2135910-74-4
Acute Tox. 4; Skin Sens. 1
429-240-8
212652-59-0
Eye Dam. 1
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
244-236-4
21136-70-9
Carc. 1A; Acute Tox. 4
427-580-1
211299-54-6
Skin Irrit. 2
244-214-4
21109-95-5
Acute Tox. 4
POLLENAL II
412-270-0
2109-22-0
Skin Sens. 1
433-460-1
210880-92-5
Acute Tox. 4
244-209-7
21087-64-9
Acute Tox. 4
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
-
21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
218-277-3
2104-96-3
Acute Tox. 4
218-276-8
2104-64-5
Acute Tox. 1; Acute Tox. 2

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