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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
yes
600-594-7
104653-34-1
Repr. 1B; Acute Tox. 1; STOT RE 1
600-533-4
104206-82-8
Repr. 2; STOT RE 2
600-425-7
103361-09-7
Repr. 2
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
yes
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
600-130-3
100784-20-1
Repr. 1B
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
500-036-1
25214-70-4
yes
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
500-024-6
9016-45-9
yes
451-440-9
586372-44-3
Eye Dam. 1
451-430-4
500717-36-2
Eye Dam. 1; Skin Sens. 1
450-010-8
-
Eye Dam. 1; Skin Sens. 1
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
447-880-6
206565-89-1
Skin Irrit. 2; 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
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
445-990-9
376588-17-9
Skin Sens. 1
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
445-760-8
-
Eye Dam. 1; Resp. Sens. 1
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1
444-970-7
7340-90-1
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
444-860-9
474510-57-1
STOT RE 2
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
444-480-3
393517-29-8
Skin Irrit. 2
444-440-5
220689-12-3
Acute Tox. 4
444-350-6
133413-70-4
Eye Irrit. 2
444-320-2
-
Acute Tox. 4
444-290-0
508202-43-5
Eye Dam. 1; Skin Sens. 1
444-250-2
144111-81-9
Self-react. C
444-050-5
-
Eye Dam. 1
443-980-9
221215-20-9
Skin Sens. 1
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
443-560-5
88784-33-2
Eye Irrit. 2
443-150-6
101226-85-1
Flam. Liq. 3
443-120-2
393509-79-0
Eye Dam. 1
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
442-860-3
87333-22-0
Skin Sens. 1
442-850-9
114772-40-6
Skin Sens. 1
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
442-800-6
-
Skin Irrit. 2
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
442-300-8
-
Skin Sens. 1
442-290-5
457624-86-1
Eye Dam. 1
442-230-8
321679-52-1
Eye Dam. 1
442-030-0
321912-47-4
Eye Dam. 1
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
441-550-5
-
Self-react. C; Carc. 2
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
441-070-6
61826-76-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
440-770-9
371921-63-0
Eye Dam. 1
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
440-510-4
-
Eye Dam. 1; Skin Sens. 1
440-480-2
341026-59-3
Eye Dam. 1; Skin Sens. 1
440-460-3
252579-81-0
Eye Irrit. 2
440-030-5
338735-71-0
Skin Irrit. 2; Eye Dam. 1
439-540-0
-
Skin Irrit. 2; Skin Sens. 1
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
438-670-5
87199-17-5
Skin Sens. 1
438-310-7
-
Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
437-720-3
227085-51-0
Eye Dam. 1
436-920-8
172399-10-9
Eye Dam. 1
436-890-6
-
Eye Dam. 1
436-690-9
220727-26-4
Skin Sens. 1
435-960-3
-
Carc. 1B; Muta. 1B; Skin Sens. 1
435-860-1
214417-91-1
Skin Sens. 1
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
435-500-1
152460-07-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
435-470-1
27366-72-9
Repr. 1B
435-450-0
5460-63-9
Skin Sens. 1
435-440-6
-
Eye Dam. 1
435-350-7
141250-43-3
Eye Dam. 1
435-180-3
-
Asp. Tox. 1; Skin Irrit. 2
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
435-080-1
1070-64-0
Skin Sens. 1
435-010-8
26157-73-3
Muta. 2
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
434-990-4
7331-52-4
Skin Sens. 1
434-820-9
106461-41-0
STOT RE 2
434-630-6
60372-77-2
Eye Dam. 1
434-480-1
32047-53-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
434-420-4
-
Skin Irrit. 2; Eye Dam. 1
434-360-9
91125-43-8
Eye Dam. 1; Skin Sens. 1
434-350-4
103122-66-3
Flam. Liq. 3; Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
434-330-5
-
Carc. 2; Skin Sens. 1
434-290-9
249630-78-2
Acute Tox. 4
434-270-1
6261-30-9
Skin Irrit. 2; Eye Dam. 1
434-240-6
-
Skin Sens. 1
434-120-3
1380001-48-8
Skin Sens. 1
433-910-5
145153-52-2
Skin Sens. 1
433-900-0
55066-49-4
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
433-860-4
-
Eye Irrit. 2; Skin Sens. 1
433-820-6
118058-74-5
Eye Irrit. 2
TRYPROPYLAMMONIUM DIHYDROGENPHOSPHAT
433-700-3
35687-90-2
Acute Tox. 4
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
433-640-8
-
Pyr. Sol. 1
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
433-560-3
15375-21-0
Repr. 2
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
433-490-3
6563-83-3
Skin Sens. 1
433-460-1
210880-92-5
Acute Tox. 4
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
433-010-2
2135910-74-4
Acute Tox. 4; Skin Sens. 1
432-980-4
243858-60-8
Eye Dam. 1
432-960-5
124655-09-0
Acute Tox. 4
432-860-1
255387-46-3
Skin Sens. 1
432-840-2
220926-97-6
Acute Tox. 4
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
432-750-3
109202-58-6
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
HWL-158
432-590-4
243869-48-9
Eye Irrit. 2
432-560-0
61721-07-1
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
432-550-6
243858-01-7
Eye Dam. 1
432-530-7
24294-01-7
Acute Tox. 4
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
432-400-1
10102-09-7
Skin Corr. 1A
432-360-3
105813-13-6
Acute Tox. 4; Skin Sens. 1
432-350-9
81752-87-6
Skin Irrit. 2
432-310-0
617-55-0
Flam. Liq. 3; Eye Dam. 1; Skin Sens. 1
432-270-4
221354-37-6
Repr. 2; STOT RE 2
432-240-0
12056-51-8
Carc. 2
432-230-6
-
STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
432-200-2
1379679-02-3
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
432-190-1
182176-52-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1
432-140-7
110235-47-7
Carc. 2
432-100-9
-
Eye Dam. 1
431-950-8
179474-79-4
Acute Tox. 4; Skin Corr. 1B
431-930-9
43028-69-9
Acute Tox. 4; Skin Sens. 1
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
431-760-5
27460-02-2
Skin Irrit. 2
431-730-1
4277-06-9
Skin Irrit. 2; Skin Sens. 1
431-720-7
90886-53-6
Skin Corr. 1B; Acute Tox. 4
LUPEROX 570
431-610-9
68860-54-8
Org. Perox. D; Skin Sens. 1
431-600-4
112226-61-6
Skin Sens. 1
431-540-9
170573-32-7
Skin Irrit. 2
431-530-4
1380226-29-8
Skin Corr. 1A; Skin Sens. 1
431-520-1
64485-90-1
Flam. Sol. 1; Carc. 2
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
431-500-0
226065-73-2
Skin Sens. 1
431-450-1
41870-52-4
Skin Irrit. 2
431-440-5
-
Eye Dam. 1
431-430-0
103976-28-9
Acute Tox. 4
431-400-7
57374-49-9
Skin Sens. 1
2-BUTYLOCTANEDIOIC ACID
431-210-4
50905-10-7
Eye Dam. 1
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
431-180-2
5271-27-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
431-120-5
-
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
431-060-1
153719-38-1
Acute Tox. 4; Skin Sens. 1
431-030-6
163269-30-5
Acute Tox. 3; STOT RE 2; Eye Dam. 1
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
431-010-7
154486-26-7
Acute Tox. 4; Eye Dam. 1
430-920-1
73096-98-7
Acute Tox. 4; Eye Dam. 1
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
430-900-2
192725-50-1
Eye Dam. 1
430-890-1
81992-66-7
Skin Sens. 1
430-840-7
202483-63-4
Skin Sens. 1
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
430-800-9
129228-21-3
Skin Irrit. 2
430-790-6
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
430-780-1
103146-25-4
Acute Tox. 4; Skin Sens. 1
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
430-760-2
219861-18-4
Acute Tox. 4; Skin Sens. 1
430-730-9
-
Eye Dam. 1
430-700-5
10138-36-0
Skin Sens. 1
430-690-2
52783-21-8
Skin Irrit. 2
430-630-5
10596-22-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
430-580-4
-
Skin Irrit. 2
430-560-5
180637-89-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
430-390-1
845730-14-5
Acute Tox. 4
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1

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