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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 January 2022. Database contains 4812 unique substances/entries.
Filter the list

203-770-8
110-46-3
Flam. Liq. 2; Acute Tox. 4
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
-
-
Skin Sens. 1
432-360-3
105813-13-6
Acute Tox. 4; Skin Sens. 1
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
256-032-2
42978-66-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
-
-
Skin Irrit. 2
427-580-1
2135337-60-7
Skin Irrit. 2
-
135821-03-3
yes
-
135821-74-8
yes
P-NITROBENZYLESTER PGSO
412-670-5
54275-93-3
Resp. Sens. 1
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
SERTRALINE STEP 2
420-560-3
79617-97-3
Eye Dam. 1
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
426-740-8
-
Acute Tox. 4; Eye Dam. 1
BLUE 10 25 964
407-240-9
159604-94-1
Skin Sens. 1
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
420-370-0
6485-67-2
Eye Irrit. 2; Skin Sens. 1
-
75166-31-3
yes
-
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
433-820-6
118058-74-5
Eye Irrit. 2
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
-
75166-30-2
yes
443-560-5
88784-33-2
Eye Irrit. 2
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
CIN 10094329; SENSIBILISATOR KF 693 PINA; SENSITIZER KF 693 PINA
422-240-9
166596-68-5
Eye Dam. 1; Skin Sens. 1
428-230-0
79568-06-2
STOT RE 2
222-048-3
3327-22-8
Carc. 2
T 1569; T001569
423-290-4
66938-41-8
Muta. 2
444-350-6
133413-70-4
Eye Irrit. 2
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
17-KETOBROMOHYDRINE
419-790-7
4229-69-0
Skin Sens. 1
SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
405-020-7
105024-66-6
Repr. 1B
SULPHAZINE
406-090-1
81880-96-8
Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1
692-456-8
688046-61-9
Carc. 2
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
433-490-3
6563-83-3
Skin Sens. 1
E.M.A.
406-790-7
26116-56-3
Eye Dam. 1
244-445-0
21564-17-0
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
401-450-4
95154-01-1
Skin Sens. 1
402-460-1
-
Skin Irrit. 2; Skin Sens. 1
204-647-1
123-73-9
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
227-678-2
5932-68-3
Skin Sens. 1A
421-370-3
3681-73-0
Skin Irrit. 2
DPP
410-980-5
112704-51-5
Eye Irrit. 2; Skin Sens. 1
PYRIDYLACROLEIN
426-330-9
177964-68-0
Eye Irrit. 2; Skin Sens. 1
CP-166,221
428-010-4
82413-20-5
Carc. 2; Repr. 1B; Skin Sens. 1
429-900-5
82356-51-2
Skin Sens. 1
210-855-3
624-64-6
Flam. Gas 1; Press. Gas
NCC ETHER
406-100-4
94097-88-8
Skin Sens. 1
423-240-1
125474-34-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
MEXORYL SX; SX 32
410-960-6
92761-26-7
Eye Dam. 1
418-960-8
-
Skin Corr. 1B; Skin Sens. 1
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-471-8
85508-46-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
CARTASOL GEEL M-GL CONC.; CARTASOL GELB M-GL FLÜSSIG (ZUBEREITUNG); CARTASOL GELB M-GL KONZ.; CARTASOL YELLOW M-GL CONC.; HM 2580
401-500-5
118658-99-4
Carc. 1B
TICA 118
422-200-0
178277-55-9
Skin Corr. 1B; Acute Tox. 4
444-320-2
-
Acute Tox. 4
-
178961-20-1
Skin Sens. 1
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
226-908-9
5543-58-8
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
238-967-8
14898-79-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
236-232-6
13250-12-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
-
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
431-210-4
50905-10-7
Eye Dam. 1
-
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
701-225-3
1101132-67-5
Carc. 2; Repr. 2; STOT RE 2
UK-88,861-04
421-810-4
194602-27-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
411-150-5
29617-66-1
Acute Tox. 4; Skin Corr. 1A
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
226-907-3
5543-57-7
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
-
-
Acute Tox. 4; Skin Sens. 1
224-168-1
4221-99-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
412-470-8
73246-45-4
Flam. Liq. 3; STOT RE 2; Eye Irrit. 2
227-815-6
5989-54-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
208-164-7
513-49-5
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
BMS 187266-02; S-TIPAC
430-300-0
76932-17-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
BENACTIVE GOLDEN YELLOW CN-GL; C.I. REACTIVE YELLOW 178; KAYACELON REACT GOLDEN YELLOW CN-GL; SOMAZIN GOLDEN YELLOW CN-GL
404-250-5
115099-55-3
Skin Sens. 1
CARTASOL TUERKIS K-ZBL KONC.; CARTASOL TURQUOISE K-JD 2336; CARTASOL TURQUOISE K-JD 2336 CONC.; CARTASOL TURQUOISE K-ZBL CONC.; CARTASOL TÜRKIS K-ZBL FLÜSSIG; CARTASOL TÜRKIS K-ZBL KONZ.; TURQUOISE CARTASOL K-JD 2336 CONC.
401-260-1
118800-27-4
Eye Irrit. 2
C.I. REAKTIV-BLAU 216; KAYACELON REACT BLUE CN-BL; KAYACELON REAKT-BLAU CN-BL; UBCNBL
404-670-9
89797-01-3
Skin Sens. 1
424-740-2
138271-16-6
Acute Tox. 4; Eye Dam. 1
233-195-8
10061-01-5
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
410-780-8
-
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
CLEARFRAC J508B
426-210-6
120086-58-0
Skin Corr. 1B
430-100-3
86978-24-7
Acute Tox. 4
227-633-7
5912-86-7
Skin Sens. 1A
431-520-1
64485-90-1
Flam. Sol. 1; Carc. 2
209-673-7
590-18-1
Flam. Gas 1; Press. Gas
204-015-5
112-90-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
600-853-4
107898-54-4
Skin Irrit. 2
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
430-730-9
-
Eye Dam. 1
-
99095-19-9
Acute Tox. 4; Skin Sens. 1
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
BRL 44742
415-550-0
109887-53-8
Acute Tox. 4; Eye Dam. 1
419-290-9
-
Skin Sens. 1
CG 24-020; FERROCEN-SBF6
407-840-0
100011-37-8
Acute Tox. 4; Eye Dam. 1
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
204-528-4
122-20-3
Eye Irrit. 2
COMPIMIDE™ 121
405-840-5
110866-35-8
Skin Sens. 1
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
203-820-9
110-97-4
Eye Irrit. 2
430-250-1
406-58-6
Flam. Liq. 2
200-756-3
71-55-6
Acute Tox. 4
201-191-5
79-27-6
Acute Tox. 2; Eye Irrit. 2
201-197-8
79-34-5
Acute Tox. 2; Acute Tox. 1
201-166-9
79-00-5
Carc. 2; Acute Tox. 4
D 28-283
419-430-9
56533-00-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
209-854-0
594-72-9
Acute Tox. 3
200-863-5
75-34-3
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
200-864-0
75-35-4
Flam. Liq. 1; Carc. 2; Acute Tox. 4
209-253-3
563-58-6
Flam. Liq. 2; Acute Tox. 3
203-310-6
105-57-7
Flam. Liq. 2; Eye Irrit. 2; Skin Irrit. 2
413-740-8
1132-95-2
Skin Corr. 1B
208-589-8
534-15-6
Flam. Liq. 2
-
4482-55-7
Skin Irrit. 2
246-147-6
24307-26-4
Acute Tox. 4
LUPEROX 570
431-610-9
68860-54-8
Org. Perox. D; Skin Sens. 1
200-629-2
66-71-7
Acute Tox. 3
210-168-9
608-73-1
Carc. 2; Acute Tox. 3; Acute Tox. 4
212-230-0
771-29-9
Org. Perox. D; Acute Tox. 4; Skin Corr. 1B
RO 1173
414-270-6
41959-35-7
Acute Tox. 4
204-340-2
119-64-2
Eye Irrit. 2; Skin Irrit. 2
-
6202-15-9
Expl. 1.1; Acute Tox. 4
212-557-9
826-62-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
226-247-6
5333-84-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
222-323-8
3425-89-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
247-830-1
26590-20-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
206-022-9
288-88-0
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
204-428-0
120-82-1
Acute Tox. 4; Skin Irrit. 2
202-436-9
95-63-6
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
221-695-9
3194-55-6
Repr. 2; Lact.
yes
271-094-0
68515-51-5
yes
271-093-5
68515-50-4
Repr. 1B
yes
284-032-2
84777-06-0
Repr. 1B
yes
272-013-1
68648-93-1
yes
276-158-1
71888-89-6
Repr. 1B
yes
271-084-6
68515-42-4
Repr. 1B
yes
220-120-9
2634-33-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-977-3
112-49-2
Repr. 1B
yes
REACTIVE NAVY DER 7678
417-610-1
155522-09-1
Skin Sens. 1
3,4-DIACETOXY-1-BUTENE
421-720-5
18085-02-4
Acute Tox. 4
202-479-3
96-12-8
Carc. 1B; Muta. 1B; Repr. 1A; Acute Tox. 3; STOT RE 2
203-444-5
106-93-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-425-9
95-50-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
208-750-2
540-59-0
Flam. Liq. 2; Acute Tox. 4
201-152-2
78-87-5
Flam. Liq. 2; Carc. 1B; Acute Tox. 4
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
1,2-DIETHOXYPROPANE; DIETHOXY-1,2-PROPANE
412-180-1
10221-57-5
Flam. Liq. 2
FAT 92'364/A
411-990-2
68612-94-2
Skin Sens. 1
204-427-5
120-80-9
Carc. 1B; Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes
404-630-0
7778-85-0
Flam. Liq. 2
256-152-5
43222-48-6
Acute Tox. 4
424-070-0
94346-09-5
Skin Irrit. 2
-
540-73-8
Carc. 1B; Acute Tox. 3
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
208-431-8
528-29-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-438-2
106-88-7
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
202-752-7
99-35-4
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-812-5
110-88-3
Flam. Sol. 1; Repr. 2; STOT SE 3
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
241-536-7
17557-23-2
Skin Irrit. 2; Skin Sens. 1
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
420-930-4
135756-61-5
Acute Tox. 4; Eye Dam. 1
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
423-300-7
128554-52-9
Skin Sens. 1
JAUNE REACTIF MUB 151
415-100-3
149850-29-3
Skin Sens. 1
203-450-8
106-99-0
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
420-060-5
117663-11-3
Flam. Liq. 3; Org. Perox. D
208-792-1
541-73-1
Acute Tox. 4
202-491-9
96-23-1
Carc. 1B; Acute Tox. 3; Acute Tox. 4
401-570-7
89415-87-2
Ox. Sol. 1; Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1

export-type