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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 svibnja 2024. Database contains 4821 unique substances/entries.
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444-970-7
7340-90-1
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
202-039-0
91-08-7
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
203-710-0
109-83-1
Acute Tox. 4; Skin Corr. 1B
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
210-843-8
624-41-9
Flam. Liq. 3
252-343-2
35073-27-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
219-449-0
2438-20-2
Flam. Liq. 3
209-512-0
583-59-5
Acute Tox. 4
209-513-6
583-60-8
Flam. Liq. 3; Acute Tox. 4
209-747-9
592-27-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-730-6
591-76-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
211-765-7
693-98-1
Repr. 1B
yes
220-239-6
2682-20-4
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
203-489-0
107-41-5
Eye Irrit. 2; Skin Irrit. 2
201-148-0
78-83-1
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-889-7
75-65-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
204-066-3
115-11-7
Flam. Gas 1; Press. Gas
D(+)-LACTATE D'ISOBUTYLE
407-770-0
61597-96-4
Eye Irrit. 2
VINYLMILCHSÄURE-ISO-BUTYLESTER
406-235-9
72531-53-4
Eye Irrit. 2; Skin Irrit. 2
203-643-7
109-06-8
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
210-256-7
611-15-4
Acute Tox. 4
SUBSTANCE S123386; VANQUISH 100
420-590-7
4299-07-4
Skin Corr. 1B; Skin Sens. 1
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
205-182-7
135-19-3
Acute Tox. 4
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
202-547-2
96-96-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
209-474-5
581-89-5
Carc. 1B
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
204-589-7
122-99-6
Acute Tox. 4; STOT SE 3; Eye Dam. 1
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1
2-PHENYLETHYLISOCYANAT; 2-PHENYLETHYLISOCYANATE; PHENYL ETHYL ISOCYANATE
413-080-0
1943-82-4
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
SALICYNALVA
423-460-8
3508-98-3
Acute Tox. 4
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
2-ADPS
413-030-8
1134-94-7
Skin Sens. 1
426-400-9
170222-39-6
Skin Sens. 1
205-411-0
140-31-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
223-228-4
3775-90-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
687-833-9
1119449-38-5
yes
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
442-230-8
321679-52-1
Eye Dam. 1
248-743-1
27942-27-4
yes
219-682-8
2497-59-8
yes
604-395-6
14409-72-4
yes
247-816-5
26571-11-9
yes
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
COUPLER II; UC-136
406-200-8
117827-06-2
Skin Sens. 1
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
BASIC RED FC 48215
406-055-0
124584-00-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
440-770-9
371921-63-0
Eye Dam. 1
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
204-355-4
119-90-4
Carc. 1B; Acute Tox. 4
200-261-2
56-18-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
209-243-9
563-16-6
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-230-8
562-49-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
431-500-0
226065-73-2
Skin Sens. 1
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
202-448-4
95-76-1
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
209-504-7
583-48-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-415-3
577-71-9
Acute Tox. 3; STOT RE 2
210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
AF-389
407-990-7
141915-64-2
Skin Sens. 1
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
220-630-1
2840-00-8
Acute Tox. 4
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
DCATFOB; XRD 473 ANILINE
401-790-3
104147-32-2
Acute Tox. 4
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
203-606-5
108-68-9
Acute Tox. 3; Skin Corr. 1B
223-775-9
4067-16-7
Skin Corr. 1B; Skin Sens. 1
203-986-2
112-57-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-950-6
112-24-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
218-951-7
2300-66-5
Eye Irrit. 2
225-918-0
5146-66-7
Muta. 1B
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
IMEXINE FAG
410-910-3
104226-19-9
Skin Sens. 1
427-370-1
164288-56-6
Eye Dam. 1
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 1
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1

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