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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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246-901-4
25366-23-8
Acute Tox. 4
248-924-5
28249-77-6
Acute Tox. 4
206-049-6
297-97-2
Acute Tox. 1; Acute Tox. 2
245-740-7
23564-05-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Sens. 1
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
432-270-4
221354-37-6
Repr. 2; STOT RE 2
-
26766-27-8
Acute Tox. 4
245-986-5
24017-47-8
Acute Tox. 3; Acute Tox. 4
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
219-014-5
2314-97-8
Muta. 2
220-449-8
2768-02-7
Skin Sens. 1B
247-759-6
26523-78-4
Skin Sens. 1
yes
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
429-240-8
212652-59-0
Eye Dam. 1
246-677-8
25155-23-1
Repr. 1B
yes
218-828-8
2244-21-5
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
220-767-7
2893-78-9
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
D,L-VALINEAMIDE
402-840-7
20108-78-5
Repr. 2; Eye Irrit. 2; Skin Sens. 1
218-894-8
2275-23-2
Acute Tox. 3; Acute Tox. 4
607-955-8
2655-14-3
Acute Tox. 4
219-364-9
2425-10-7
Acute Tox. 4
444-480-3
393517-29-8
Skin Irrit. 2
222-048-3
3327-22-8
Carc. 2
HEXAROSE
421-370-3
3681-73-0
Skin Irrit. 2
420-610-4
36394-75-9
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
253-242-6
36861-47-9
yes
222-323-8
3425-89-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
221-695-9
3194-55-6
Repr. 2; Lact.
yes
DE 3
413-140-6
3459-83-4
Flam. Liq. 3
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
MIXOFAM
411-510-1
3353-51-3
Skin Sens. 1
434-480-1
32047-53-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
METHOXYISOPROPYLAMINE
422-550-4
37143-54-7
Flam. Liq. 2; Skin Corr. 1B; Acute Tox. 4
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
yes
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
253-057-0
36483-57-5
yes
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
221-221-0
3033-77-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
223-383-8
3864-99-1
yes
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
206-348-1
329-71-5
Acute Tox. 3; STOT RE 2
440-030-5
338735-71-0
Skin Irrit. 2; Eye Dam. 1
253-037-1
36437-37-3
yes
XU 40304.03L ANTIMICROBIAL
405-640-8
36362-09-1
STOT RE 2; Skin Irrit. 2; Eye Dam. 1
AMINOETHER
412-310-7
37866-45-8
Skin Sens. 1
222-598-4
3547-33-9
Eye Dam. 1
223-346-6
3846-71-7
yes
EF-40
406-110-9
35950-52-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1

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