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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 srpnja 2024. Database contains 4821 unique substances/entries.
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218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye 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
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
429-120-5
208535-04-0
Eye Dam. 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
244-073-9
20837-86-9
yes
244-058-7
20816-12-0
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
606-640-2
2079-00-7
Acute Tox. 2
218-196-3
2074-50-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
422-260-8
20701-68-2
Eye Dam. 1
205-916-6
207-08-9
Carc. 1B
yes
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
O-NITROBENZALDEHYDDIMETHYLACETAL
423-830-9
20627-73-0
Skin Sens. 1
218-173-8
2062-98-8
yes
205-912-4
206-44-0
yes
218-165-4
2058-94-8
yes
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
243-873-5
20548-54-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
243-867-2
20543-06-0
Carc. 1A; STOT RE 1; Skin Sens. 1
218-130-3
2051-79-8
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
205-911-9
205-99-2
Carc. 1B
205-910-3
205-82-3
Carc. 1B
606-566-0
20487-40-5
Flam. Liq. 2
243-816-4
20427-84-3
yes
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
429-020-1
204254-96-6
STOT RE 2; Skin Sens. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
217-991-2
2032-65-7
Acute Tox. 3
217-990-7
2032-59-9
Acute Tox. 3
426-900-7
203118-12-1
STOT SE 3
427-850-9
202667-43-4
Skin Sens. 1
430-840-7
202483-63-4
Skin Sens. 1
427-730-6
202420-04-0
Skin Corr. 1B
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
243-547-2
20153-50-8
Acute Tox. 4
243-546-7
20153-49-5
Acute Tox. 4
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
D,L-VALINEAMIDE
402-840-7
20108-78-5
Repr. 2; Eye Irrit. 2; Skin Sens. 1
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
429-400-7
199327-61-2
Repr. 1B
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
-
198840-65-2
yes
217-862-0
1987-50-4
yes
243-269-1
19750-95-9
Carc. 2; Acute Tox. 4
425-520-9
197179-61-6
Eye Dam. 1
243-193-9
19622-19-6
Acute Tox. 4
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
419-570-0
195006-58-7
Acute Tox. 4
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
UK-88,861-04
421-810-4
194602-27-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
425-870-2
19450-38-5
Skin Sens. 1
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
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
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
-
19372-20-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
217-685-9
1929-88-0
Acute Tox. 4
217-682-2
1929-82-4
Acute Tox. 4
217-681-7
1929-77-7
Acute Tox. 4
430-900-2
192725-50-1
Eye Dam. 1
F.H.D.A.
403-510-5
19247-05-3
Acute Tox. 3; STOT RE 2; Skin Sens. 1
205-892-7
192-97-2
Carc. 1B
426-860-0
191877-09-5
Eye Dam. 1
620-362-9
1918-18-9
Acute Tox. 4
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
217-637-7
1918-13-4
Acute Tox. 4
217-635-6
1918-00-9
Acute Tox. 4; Eye Dam. 1
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
205-886-4
191-30-0
Carc. 1B; Muta. 2
205-883-8
191-24-2
yes
242-818-2
19098-16-9
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
424-850-0
189702-72-5
Eye Dam. 1
217-588-1
1897-45-6
Carc. 2; Acute Tox. 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
TETRACHLOROTEREPHTHALONITRILE
401-550-8
1897-41-2
Skin Sens. 1
606-168-7
189278-12-4
Carc. 2
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
205-878-0
189-64-0
Carc. 1B; Muta. 2
205-877-5
189-55-9
Carc. 1B; Muta. 2
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
242-624-8
18854-01-8
Acute Tox. 3
424-290-7
188070-47-5
Skin Sens. 1
SUBSTANCE S44176
414-570-7
18759-96-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
426-590-3
187412-41-5
Skin Sens. 1
428-700-5
1873-90-1
Acute Tox. 4
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
242-533-3
18721-51-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
242-522-3
18718-11-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1

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