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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
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Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
232-089-9
7785-87-7
STOT RE 2
232-066-3
7784-42-1
Flam. Gas 1; Press. Gas; Acute Tox. 2; STOT RE 2
232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
yes
232-009-2
7783-56-4
Acute Tox. 3
231-977-3
7783-06-4
Flam. Gas 1; Press. Gas; Acute Tox. 2
616-510-7
7782-63-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
231-959-5
7782-50-5
Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
231-957-4
7782-49-2
Acute Tox. 3; STOT RE 2
231-956-9
7782-44-7
Ox. Gas 1; Press. Gas
231-954-8
7782-41-4
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1A
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
EXPERIMENTAL DIETHER MM; HISOLVE MMPOM
404-630-0
7778-85-0
Flam. Liq. 2
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
231-908-7
7778-54-3
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1B
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-904-5
7778-44-1
yes
231-901-9
7778-39-4
Carc. 1A; Acute Tox. 3
yes
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
231-889-5
7775-11-3
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-887-4
7775-09-9
Ox. Sol. 1; Acute Tox. 4
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
231-853-9
7761-88-8
Ox. Sol. 2; Skin Corr. 1B
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
231-846-0
7758-97-6
Carc. 1B; Repr. 1A; STOT RE 2
yes
231-842-9
7758-89-6
Acute Tox. 4
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
231-827-7
7757-95-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
MAGME(R) 200 MONOMER
403-230-3
77402-05-2
Carc. 1B; Muta. 1B; Skin Corr. 1B; Skin Sens. 1
MAGME 100 MONOMEER
401-890-7
77402-03-0
Carc. 1B; Muta. 1B; Acute Tox. 4; Eye Irrit. 2
231-801-5
7738-94-5
yes
EPSI
410-220-2
77375-79-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
426-890-4
77341-67-4
Eye Dam. 1
231-793-3
7733-02-0
Acute Tox. 4; Eye Dam. 1
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 1
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
231-781-8
7727-21-1
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
231-778-1
7726-95-6
Acute Tox. 2; Skin Corr. 1A
231-768-7
7723-14-0
Flam. Sol. 1
3-CHLORO-4,5-DIFLUOROBENZOTRIFLUORIDE
401-930-3
77227-99-7
Flam. Liq. 3; Acute Tox. 4
231-765-0
7722-84-1
Ox. Liq. 1; Acute Tox. 4; Skin Corr. 1A
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
JOF 2822 5F; JOF 2822 5FL; JOF 4443
420-960-8
77214-82-5
Eye Dam. 1
231-753-5
7720-78-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
231-748-8
7719-09-7
Acute Tox. 4; Skin Corr. 1A
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
231-743-0
7718-54-9
Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
SETALUX EPC 4690
420-190-2
771478-66-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
212-230-0
771-29-9
Org. Perox. D; Acute Tox. 4; Skin Corr. 1B
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
231-722-6
7704-34-9
Skin Irrit. 2
231-720-5
7700-17-6
Acute Tox. 3
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
201-029-3
77-47-4
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
201-025-1
77-40-7
yes
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
231-714-2
7697-37-2
Ox. Liq. 3; Acute Tox. 3; Skin Corr. 1A
231-711-6
7696-12-0
Carc. 2; Acute Tox. 4; STOT SE 2
BMS 187266-02; S-TIPAC
430-300-0
76932-17-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 1
231-673-0
7681-57-4
Acute Tox. 4; Eye Dam. 1
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1
231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
231-665-7
7681-38-1
Eye Dam. 1
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
617-485-5
76714-88-0
Acute Tox. 4
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
231-639-5
7664-93-9
Skin Corr. 1A
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
231-633-2
7664-38-2
Skin Corr. 1B
BRIGHTENER SM 1018 CONC.; LEUCOPHOR BCR
405-280-1
76508-02-6
Eye Irrit. 2
231-601-8
7647-18-9
Skin Corr. 1B
231-595-7
7647-01-0
Skin Corr. 1B; STOT SE 3
231-595-7
7647-01-0
Press. Gas; Acute Tox. 3; Skin Corr. 1A
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
231-592-0
7646-85-7
Acute Tox. 4; Skin Corr. 1B
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
231-588-9
7646-78-8
Skin Corr. 1B
231-587-3
7646-69-7
Water-react. 1
212-121-8
764-41-0
Carc. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
231-569-5
7637-07-2
Press. Gas; Acute Tox. 2; Skin Corr. 1A
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-556-4
7632-04-4
yes
231-555-9
7632-00-0
Ox. Sol. 3; Acute Tox. 3

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