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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 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
231-548-0
7631-90-5
Acute Tox. 4
212-105-0
762-75-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
231-512-4
7601-90-3
Ox. Liq. 1; Skin Corr. 1A
231-511-9
7601-89-0
Ox. Sol. 1; Acute Tox. 4
200-990-6
76-87-9
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-962-3
76-44-8
Carc. 2; Acute Tox. 3; STOT RE 2
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
200-927-2
76-03-9
Skin Corr. 1A
200-925-1
76-01-7
Carc. 2; STOT RE 1
278-355-8
75980-60-8
Repr. 2
212-073-8
759-94-4
Acute Tox. 4
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
231-480-1
7580-31-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
620-436-0
75736-33-3
Eye Irrit. 2
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
231-442-4
7553-56-2
Acute Tox. 4
DISPERSOL YELLOW XF
407-970-8
75511-91-0
Skin Sens. 1
231-441-9
7550-45-0
Skin Corr. 1B
KHUSINIL
422-580-8
75490-39-0
Acute Tox. 4
616-221-6
7541-49-3
Skin Irrit. 2
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
-
75166-31-3
yes
-
75166-30-2
yes
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
200-915-7
75-91-2
Muta. 2
200-909-4
75-86-5
Acute Tox. 2; Acute Tox. 1
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
200-906-8
75-83-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
200-902-6
75-79-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-898-6
75-75-2
Skin Corr. 1B
200-889-7
75-65-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
200-876-6
75-52-5
Flam. Liq. 3; Acute Tox. 4
200-875-0
75-50-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-875-0
75-50-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
200-870-3
75-44-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
200-864-0
75-35-4
Flam. Liq. 1; Carc. 2; Acute Tox. 4
200-863-5
75-34-3
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
200-860-9
75-31-0
Flam. Liq. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-858-8
75-29-6
Flam. Liq. 2; Acute Tox. 4
200-857-2
75-28-5
Flam. Gas 1; Press. Gas
200-857-2
75-28-5
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
200-855-1
75-26-3
Flam. Liq. 2; Repr. 1A; STOT RE 2
200-854-6
75-25-2
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
200-849-9
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
200-848-3
75-20-7
Water-react. 1
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
200-843-6
75-15-0
Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
200-842-0
75-12-7
Repr. 1B
yes
200-838-9
75-09-2
Carc. 2
200-837-3
75-08-1
Flam. Liq. 2; Acute Tox. 4
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
200-834-7
75-04-7
Flam. Gas 1; Press. Gas; Eye Irrit. 2; STOT SE 3
200-831-0
75-01-4
Press. Gas; Flam. Gas 1; Carc. 1A
200-830-5
75-00-3
Flam. Gas 1; Press. Gas; Carc. 2
231-299-8
7487-94-7
Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1; Skin Corr. 1B
A complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range C15 through C50.
278-012-2
74869-22-0
Carc. 1B
A complex combination of hydrocarbons having carbon numbers predominantly in the range of C12 through C50. May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.
278-011-7
74869-21-9
Carc. 1B
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
277-985-0
74753-18-7
Carc. 1B; Acute Tox. 4
-
74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
616-100-8
74499-35-7
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
231-208-1
7446-70-0
Skin Corr. 1B
231-205-5
7446-27-7
Repr. 1A; STOT RE 2
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
231-201-3
7446-18-6
Acute Tox. 2; STOT RE 1; Skin Irrit. 2
231-195-2
7446-09-5
Press. Gas; Acute Tox. 3; Skin Corr. 1B
231-187-9
7443-70-1
Acute Tox. 4
231-186-3
7443-52-9
Acute Tox. 4
N-METHYL-4-(P-FORMYLSTYRYL)-PYRIDINIUM METHYLSULFATE; SBQ; SBQ-SALZ
418-240-3
74401-04-0
Skin Sens. 1
231-179-5
7440-70-2
Water-react. 2
231-176-9
7440-67-7
Self-heat. 1
231-176-9
7440-67-7
Water-react. 1; Pyr. Sol. 1
231-175-3
7440-66-6
Water-react. 1; Pyr. Sol. 1
231-170-6
7440-61-1
Acute Tox. 2; STOT RE 2
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
231-152-8
7440-43-9
Pyr. Sol. 1; Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
231-152-8
7440-43-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
231-152-8
7440-43-9
yes
231-150-7
7440-41-7
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
231-148-6
7440-38-2
Acute Tox. 3
231-138-1
7440-28-0
Acute Tox. 2; STOT RE 2
231-132-9
7440-23-5
Water-react. 1; Skin Corr. 1B
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
231-106-7
7439-97-6
Repr. 1B; Acute Tox. 2; STOT RE 1
231-104-6
7439-95-4
Flam. Sol. 1; Water-react. 2; Self-heat. 1
231-104-6
7439-95-4
Water-react. 1; Pyr. Sol. 1

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