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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 lipnja 2024. Database contains 4821 unique substances/entries.
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HWL-158
432-590-4
243869-48-9
Eye Irrit. 2
205-910-3
205-82-3
Carc. 1B
205-916-6
207-08-9
Carc. 1B
yes
219-348-1
2421-28-5
Eye Irrit. 2; STOT SE 3
B2,4DBB
420-710-8
23085-60-1
Repr. 2; Skin Irrit. 2; Skin Sens. 1
-
22454-04-2
yes
-
25747-83-5
yes
249-205-9
28772-56-7
Repr. 1B; Acute Tox. 1; STOT RE 1
218-277-3
2104-96-3
Acute Tox. 4
219-376-4
2426-08-6
Flam. Liq. 3; Carc. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Sens. 1
220-600-8
2832-40-8
Carc. 2; Skin Sens. 1
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
243-873-5
20548-54-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
246-538-1
24934-91-6
Acute Tox. 1; Acute Tox. 2
247-109-1
25567-67-3
Acute Tox. 3; STOT RE 2
246-691-4
25167-80-0
Acute Tox. 4
246-698-2
25168-05-2
Acute Tox. 4
220-864-4
2921-88-2
Acute Tox. 3
244-663-6
21923-23-9
Acute Tox. 2; Acute Tox. 3
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
246-948-0
25402-06-6
Acute Tox. 4
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
433-460-1
210880-92-5
Acute Tox. 4
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
206-083-1
299-86-5
Acute Tox. 4
244-544-9
21725-46-2
Acute Tox. 4
220-130-3
2636-26-2
Acute Tox. 4
220-279-4
2699-11-8
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
220-279-4
2699-11-8
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
206-016-6
287-92-3
Flam. Liq. 2
428-340-9
238088-70-5
Skin Irrit. 2
218-827-2
2244-16-8
Skin Sens. 1
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
220-487-5
2782-57-2
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
248-523-5
27554-26-3
Repr. 1B
432-860-1
255387-46-3
Skin Sens. 1
246-673-6
25154-54-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
247-096-2
25550-58-7
Acute Tox. 3; STOT RE 2
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
220-639-0
2844-92-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
432-980-4
243858-60-8
Eye Dam. 1
423-730-5
250688-43-8
Eye Dam. 1
206-054-3
298-04-4
Acute Tox. 1; Acute Tox. 2
219-196-6
2385-85-5
Carc. 2; Repr. 2; Lact.; Acute Tox. 4
431-760-5
27460-02-2
Skin Irrit. 2
219-459-5
2439-10-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
220-472-3
2778-04-3
Acute Tox. 3
206-080-5
299-42-3
Acute Tox. 4
249-981-9
29973-13-5
Acute Tox. 4
245-949-3
23947-60-6
Acute Tox. 4
429-020-1
204254-96-6
STOT RE 2; Skin Sens. 1
244-845-5
22212-55-1
Acute Tox. 4
ET 344 SP
412-540-8
22471-55-2
Skin Irrit. 2
219-732-9
2514-53-6
Skin Irrit. 2
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
244-848-1
22224-92-6
Acute Tox. 2; Eye Irrit. 2
206-082-6
299-84-3
Acute Tox. 4
205-912-4
206-44-0
yes
243-547-2
20153-50-8
Acute Tox. 4
243-546-7
20153-49-5
Acute Tox. 4
500-036-1
25214-70-4
yes
244-879-0
22259-30-9
Acute Tox. 2; Skin Sens. 1
245-656-0
23422-53-9
Acute Tox. 2; Skin Sens. 1
219-818-6
2540-82-1
Acute Tox. 4
244-437-7
21548-32-3
Acute Tox. 1; Acute Tox. 2
206-058-5
298-12-4
Eye Dam. 1; Skin Sens. 1B
219-468-4
2439-99-8
Eye Dam. 1
GUANIDINIUMBENZOAT
429-820-0
26739-54-8
Acute Tox. 4
TILCOM HTB
411-740-2
22411-22-9
Eye Dam. 1; Skin Sens. 1
218-165-4
2058-94-8
yes
245-737-0
23560-59-0
Acute Tox. 3
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1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
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
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
247-148-4
25637-99-4
Repr. 2; Lact.
yes
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
247-143-7
25637-27-8
Acute Tox. 4
219-698-5
2499-95-8
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
244-077-0
20845-01-6
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
206-019-2
288-32-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1C
244-959-5
22398-80-7
Carc. 1B; Repr. 2; STOT RE 1
247-449-0
26087-47-8
Acute Tox. 4
206-045-4
297-78-9
Acute Tox. 1; Acute Tox. 2
ISOBUTYLVINYL ACETATE; IVA
401-170-2
24342-03-8
Flam. Liq. 3
246-814-1
25311-71-1
Acute Tox. 3
247-861-0
26635-64-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
249-707-8
29590-42-9
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
220-114-6
2631-40-5
Acute Tox. 4
244-073-9
20837-86-9
yes
247-278-1
25808-74-6
Repr. 1A; Acute Tox. 4; STOT RE 2
218-499-0
2164-08-1
Carc. 2
244-472-8
21609-90-5
Acute Tox. 3; STOT SE 1; Acute Tox. 4
249-644-6
29457-72-5
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
427-850-9
202667-43-4
Skin Sens. 1
247-722-4
26471-62-5
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1

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