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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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209-689-4
590-73-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
200-906-8
75-83-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
-
7076-53-1
Acute Tox. 3
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
PERMACHEM N21
412-380-9
69094-18-4
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Skin Sens. 1
233-539-7
10222-01-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
430-580-4
-
Skin Irrit. 2
DMBA
424-090-1
10097-02-6
Eye Dam. 1
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
yes
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
208-759-1
540-84-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
KHUSINIL
422-580-8
75490-39-0
Acute Tox. 4
209-266-4
564-02-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
207-346-3
464-06-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-855-6
594-82-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
203-874-3
111-48-8
Eye Irrit. 2
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
200-733-8
70-30-4
Acute Tox. 3
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
TG-SA
411-570-9
41481-66-7
Skin Sens. 1
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1
214-237-4
1116-54-7
Carc. 1B
203-312-7
105-59-9
Eye Irrit. 2
216-853-9
1680-21-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1
203-872-2
111-46-6
Acute Tox. 4
282-263-3
84145-37-9
Flam. Liq. 3
BLEU 1044098; BLUE 1044098
405-190-2
122371-93-1
Skin Sens. 1
BLEU 1047679; BLUE 1047679
405-200-5
104366-25-8
Skin Sens. 1
BLEU DISPERSE 370; BLEU DISPERSO 370; BLEU LIP 6994; C.I. DISPERSE BLUE 370; DISPERS BLAU 370; DISPERSE BLUE 370
403-010-7
106359-94-8
Skin Sens. 1
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
432-840-2
220926-97-6
Acute Tox. 4
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
214-012-0
1072-63-5
Repr. 1B
yes
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
ARCOSOLV PTB; ARCOSOLV(R) PTB
406-180-0
57018-52-7
Flam. Liq. 3; Eye Dam. 1
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
202-155-1
92-43-3
Acute Tox. 4
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
200-752-1
71-41-0
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
N-N-OCTYLCAPROLACTAM; N-OCTYLCAPROLACTAME
420-040-6
59227-88-2
Skin Corr. 1B; Skin Sens. 1
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
205-138-7
134-32-7
Acute Tox. 4
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
210-946-8
626-38-0
Flam. Liq. 3
423-960-6
139756-01-7
Acute Tox. 4; STOT RE 2
424-160-1
139481-22-4
Acute Tox. 4
431-180-2
5271-27-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
METHOXYISOPROPYLAMINE
422-550-4
37143-54-7
Flam. Liq. 2; Skin Corr. 1B; Acute Tox. 4
203-539-1
107-98-2
Flam. Liq. 3; STOT SE 3
202-796-7
99-87-6
Flam. Liq. 3; Acute Tox. 3; Asp. Tox. 1
204-318-2
119-38-0
Acute Tox. 1; Acute Tox. 2
434-120-3
1380001-48-8
Skin Sens. 1
602-929-2
123333-53-9
Expl. 1.3
219-989-7
2592-95-2
Expl. 1.3
418-330-2
162241-33-0
Expl. 1.1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
419-570-0
195006-58-7
Acute Tox. 4
MEP
418-200-5
69227-51-6
Muta. 2
MEM
418-250-8
65756-41-4
Muta. 2
216-374-5
1569-02-4
Flam. Liq. 3; STOT SE 3
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
SURFADONE LP-300 SURFACTANT
403-730-1
2687-96-9
Skin Corr. 1B; Skin Sens. 1
211-420-0
644-64-4
Acute Tox. 3; Acute Tox. 4
418-440-0
136997-71-2
Skin Sens. 1
203-556-4
108-16-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
O-NITROBENZALDEHYDDIMETHYLACETAL
423-830-9
20627-73-0
Skin Sens. 1
CHINOLONCARBONSÄURE 93-073; CP-70,335
413-760-7
93107-30-3
Repr. 2
421-080-7
161462-35-7
STOT RE 2
208-749-7
540-54-5
Flam. Liq. 2; Acute Tox. 4
208-846-4
543-59-9
Flam. Liq. 2; Acute Tox. 4
414-380-4
140681-55-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
203-696-6
109-69-3
Flam. Liq. 2
GM 102 E
411-370-1
82857-68-9
Acute Tox. 3; Eye Dam. 1
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
203-439-8
106-89-8
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
209-990-0
600-25-9
Acute Tox. 4
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
BROMIDE 182,780
422-850-5
148757-89-5
Skin Sens. 1
1-BROM-3,5-DIFLUORBENZOL; 1-BROMO-3,5-DIFLUOROBENZENE; BDFB
416-710-2
461-96-1
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
1-BROM-3,4,5-TRIFLUORBENZOL; 1-BROMO-3,4,5-TRIFLUOROBENZENE
418-480-9
138526-69-9
Flam. Liq. 3; Carc. 2; Skin Irrit. 2; Eye Dam. 1
422-900-6
158894-67-8
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Skin Sens. 1
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
201-162-7
78-96-6
Skin Corr. 1B
422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
451-430-4
500717-36-2
Eye Dam. 1; Skin Sens. 1
BLAU MUB 557
419-520-8
172890-93-6
Skin Sens. 1
434-480-1
32047-53-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
425-870-2
19450-38-5
Skin Sens. 1
CFA; HOE 108219
406-630-6
121626-73-1
Skin Irrit. 2
SANDUVOR 3058; SANDUVOR 3058 LIQ.
411-930-5
106917-31-1
Skin Irrit. 2; Skin Sens. 1
429-040-0
272460-97-6
Eye Dam. 1
FT-310; PF-310
407-400-8
59493-72-0
Eye Dam. 1
430-920-1
73096-98-7
Acute Tox. 4; Eye Dam. 1
MIXOFAM
411-510-1
3353-51-3
Skin Sens. 1
TRIAZAMATE
411-650-3
110895-43-7
Acute Tox. 3
420-240-3
162515-68-6
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
431-450-1
41870-52-4
Skin Irrit. 2
4'-(4-PENTYLCYCLOHEXYL)ACETOPHENONE
426-830-7
78531-59-6
Skin Sens. 1
4'-(4-HEPTYLCYCLOHEXYL)ACETOPHENONE
426-820-2
78531-60-9
Skin Sens. 1
4-(4-ETHYLCYCLOHEXYL)-ACETOPHENON
426-460-6
260415-81-4
Skin Sens. 1
4-(4-BUTYLCYCLOHEXYL)-ACETOPHENON
427-320-7
83626-30-6
Skin Sens. 1
NT-8
405-930-4
10551-42-5
Acute Tox. 4; Eye Irrit. 2
431-950-8
179474-79-4
Acute Tox. 4; Skin Corr. 1B
IODOANILINE TRIAZOLE
419-540-7
160194-26-3
Acute Tox. 4; Skin Sens. 1
427-450-4
152630-47-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
T1314
411-500-7
116256-11-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
-
5836-73-7
Acute Tox. 2
GOLPANOL APC
412-740-5
25965-81-5
Acute Tox. 4; Skin Sens. 1
PYRAZOL P5; PYRAZOLE DHE
429-300-3
155601-30-2
Eye Dam. 1; Skin Sens. 1
426-110-2
98377-35-6
Skin Sens. 1
246-011-6
24083-03-2
Acute Tox. 4
433-580-2
214353-17-0
Carc. 1B; Acute Tox. 4; Skin Corr. 1B
433-580-2
214353-17-0
Acute Tox. 4; Skin Corr. 1B
ORANGE DK 2764
420-950-3
163831-67-2
Eye Dam. 1
431-010-7
154486-26-7
Acute Tox. 4; Eye Dam. 1
ACYLINDANE
411-180-9
92836-10-7
Acute Tox. 4; STOT RE 2
CIB R634
406-220-7
65322-65-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
DOXAZOSIN 4; DOXAZOSIN STEP 4
415-660-9
70918-74-0
Acute Tox. 3; STOT RE 2
PTH-SUCCINIMIDESTER
418-630-3
136465-99-1
Eye Dam. 1; Skin Sens. 1
204-081-5
115-31-1
Acute Tox. 4
239-139-9
15087-24-8
yes
HÄRTER VERSUCHSPRODUKT LS 2959E; HÄRTER VP LS 2959E
411-700-4
140921-24-0
Skin Sens. 1
425-730-0
51178-75-7
Skin Sens. 1
SETALUX EPC 4690
420-190-2
771478-66-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
-
-
yes
236-948-9
13560-89-9
yes
218-817-8
2243-62-1
Carc. 2
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
204-661-8
123-91-1
Flam. Liq. 2; Carc. 1B; Eye Irrit. 2; STOT SE 3
yes
202-833-7
100-25-4
Acute Tox. 2; Acute Tox. 1; STOT RE 2
209-335-9
571-58-4
Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2
209-663-2
589-90-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
204-617-8
123-31-9
Carc. 2; Muta. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
429-370-5
220410-74-2
Acute Tox. 4
TETRACHLOROTEREPHTHALONITRILE
401-550-8
1897-41-2
Skin Sens. 1
212-121-8
764-41-0
Carc. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
203-400-5
106-46-7
Carc. 2; Eye Irrit. 2
CA 946 A
415-580-4
130841-23-5
Acute Tox. 4; Skin Sens. 1
RAPICURE CHVE
413-370-7
17351-75-6
Skin Sens. 1
219-371-7
2425-79-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
AZA-KRONE-TETRATOSYLAT
414-030-0
52667-88-6
Skin Sens. 1
AZA-KRONE-DISULFAT; SQ 84,042F
412-080-8
112193-77-8
Acute Tox. 4; STOT SE 3; Eye Dam. 1
425-450-9
294-90-6
Skin Corr. 1B; Acute Tox. 4
219-603-7
2475-45-8
Carc. 1B; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
204-077-3
115-27-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
207-964-3
503-30-0
Flam. Liq. 2; Acute Tox. 4
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
211-463-5
646-06-0
Flam. Liq. 2
202-776-8
99-65-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
UTMS
414-180-7
10218-17-4
Acute Tox. 4; Skin Irrit. 2
DE 3
413-140-6
3459-83-4
Flam. Liq. 3
208-826-5
542-75-6
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
DCEMH
401-570-7
89415-87-2
Ox. Sol. 1; Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
1,3-DICHLOR-4-FLUORBENZOL; B-7
406-160-1
1435-48-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
202-491-9
96-23-1
Carc. 1B; Acute Tox. 3; Acute Tox. 4
208-792-1
541-73-1
Acute Tox. 4
DIPND-50-AL (META)
420-060-5
117663-11-3
Flam. Liq. 3; Org. Perox. D
203-450-8
106-99-0
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
JAUNE REACTIF MUB 151
415-100-3
149850-29-3
Skin Sens. 1
423-300-7
911674-82-3
Skin Sens. 1
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
420-930-4
135756-61-5
Acute Tox. 4; Eye Dam. 1
PERKALINK 900
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
241-536-7
17557-23-2
Skin Irrit. 2; Skin Sens. 1
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
203-812-5
110-88-3
Flam. Sol. 1; Repr. 2; STOT SE 3
202-752-7
99-35-4
Expl. 1.1; 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
208-431-8
528-29-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
-
540-73-8
Carc. 1B; Acute Tox. 3
PLINYL ACETATE
424-070-0
94346-09-5
Skin Irrit. 2
256-152-5
43222-48-6
Acute Tox. 4
EXPERIMENTAL DIETHER MM; HISOLVE MMPOM
404-630-0
7778-85-0
Flam. Liq. 2
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes

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