EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).

Last updated 24 svibnja 2024. Database contains 4917 unique substances/entries.
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268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
Details
261-346-8
58591-45-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
Details
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
R Toxic for reproduction (article 57c)
Details
215-273-3
1317-42-6
Skin Sens. 1
Details
-
-
F Fungi
Details
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
Details
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
Details
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
Details
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
Details
231-842-9
7758-89-6
Acute Tox. 4
Details
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
Details
-
-
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
Details
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
Details
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
Details
KUPFER-II-METHANSULFONAT; KUPFERMETHANSULFONAT
405-400-2
54253-62-2
Acute Tox. 4; Eye Dam. 1
Details
204-810-7
126-90-9
Skin Sens. 1B
Details
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
-
-
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
-
68583-16-4
B Bacteria and similar species
Details
-
-
B Bacteria and similar species
Details
201-378-1
81-82-3
STOT RE 2
Details
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
Details
200-285-3
56-72-4
Acute Tox. 2; Acute Tox. 4
Details
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
Details
-
572-48-5
Acute Tox. 3
Details
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
-
-
B Bacteria and similar species
Details
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
Details
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
Details
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
Details
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
Details
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
208-622-6
535-89-7
Acute Tox. 2
Details
224-030-0
4170-30-3
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
231-720-5
7700-17-6
Acute Tox. 3
Details
206-083-1
299-86-5
Acute Tox. 4
Details
-
-
F Fungi
Details
-
-
F Fungi
Details
-
-
P Parasites
Details
-
-
P Parasites
Details
202-704-5
98-82-8
Flam. Liq. 3; Carc. 1B; Asp. Tox. 1; STOT SE 3
Details
206-992-3
420-04-2
Carc. 2; Repr. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1; Skin Sens. 1; Eye Dam. 1
Details
244-544-9
21725-46-2
Acute Tox. 4
Details
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
Details
220-130-3
2636-26-2
Acute Tox. 4
Details
223-099-4
3734-95-0
Acute Tox. 2; Acute Tox. 3
Details
CSDCA
419-150-7
113136-77-9
Acute Tox. 4
Details
427-230-8
5571-36-8
Repr. 1B; STOT RE 2
Details
431-730-1
4277-06-9
Skin Irrit. 2; Skin Sens. 1
Details
203-806-2
110-82-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
Details
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
RSP Respiratory sensitising properties (Article 57(f)) - human health)
Details
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
Details
203-631-1
108-94-1
Flam. Liq. 3; Acute Tox. 4
Details
235-527-7
12262-58-7
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
Details
235-527-7
12262-58-7
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
Details
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
Details
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
Details
203-629-0
108-91-8
Flam. Liq. 3; Repr. 2; Acute Tox. 4; Skin Corr. 1B
Details
CHMMS; CHMS; DYNASYLAN 9407; Z-6187
402-140-1
17865-32-6
Skin Irrit. 2
Details
220-279-4
2699-11-8
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
Details
220-279-4
2699-11-8
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
Details
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
Details
206-016-6
287-92-3
Flam. Liq. 2
Details
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
Details
204-435-9
120-92-3
Flam. Liq. 3; Eye Irrit. 2; Skin Irrit. 2
Details
428-340-9
238088-70-5
Skin Irrit. 2
Details
CHLOROFORMIATE DE CYCLOPENTYLE; CYCLOPENTYLCHLORFORMIAT
411-460-0
50715-28-1
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
Details
-
-
P Parasites
Details
405-230-9
101205-02-1
Repr. 2
Details
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
Details
269-855-7
68359-37-5
Lact.; Acute Tox. 2; STOT SE 1
Details
236-049-1
13121-70-5
Acute Tox. 4
Details
261-043-0
57966-95-7
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; STOT RE 2
Details
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
Details
601-785-8
121552-61-2
Skin Sens. 1
Details
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
Details
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
Details
218-827-2
2244-16-8
Skin Sens. 1
Details
432-960-5
124655-09-0
Acute Tox. 4
Details
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
Details
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
Details
216-485-9
1596-84-5
Carc. 2
Details
201-248-4
80-08-0
Acute Tox. 4
Details
208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
Details
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
Details
208-764-9
541-02-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
Details
-
1563-67-3
Acute Tox. 3
Details
258-256-6
52918-63-5
Acute Tox. 3
Details
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
Details
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
Details
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
Details
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
Details
212-758-1
867-27-6
Acute Tox. 3
Details
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
Details
213-052-6
919-86-8
Acute Tox. 3
Details
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
Details
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
237-198-5
13684-56-5
Repr. 2
Details
213-800-1
1014-69-3
Acute Tox. 4
Details
204-424-9
120-78-5
Skin Sens. 1
Details
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
Details
950-299-5
-
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
Details
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
Details
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
Details
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
Details
205-575-3
142-96-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
203-921-8
111-92-2
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1
Details
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
Details
205-017-9
131-18-0
Repr. 1B
R Toxic for reproduction (article 57c)
Details
CM 26-137
406-052-4
125078-60-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
203-733-6
110-05-4
Org. Perox. E; Flam. Liq. 2; Muta. 2
Details
233-689-3
10311-84-9
Acute Tox. 2; Acute Tox. 3
Details
205-016-3
131-17-9
Acute Tox. 4
Details
234-454-8
12004-35-2
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
-
-
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
Details
GENIPLEX A
401-610-3
122012-52-6
Acute Tox. 4; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
422-670-7
150202-11-2
Repr. 2; Acute Tox. 3; STOT RE 2
Details
240-973-0
16919-58-7
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
Details
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
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
Details
237-499-1
13820-41-2
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
C Carcinogenic (article 57a)
Details
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
C Carcinogenic (article 57a)
Details
206-373-8
333-41-5
Acute Tox. 4
Details
206-382-7
334-88-3
Carc. 1B
Details
200-181-8
53-70-3
Carc. 1B
Details
205-878-0
189-64-0
Carc. 1B; Muta. 2
Details
205-886-4
191-30-0
Carc. 1B; Muta. 2
Details
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
Details
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
215-125-8
1303-86-2
Repr. 1B
R Toxic for reproduction (article 57c)
Details
200-824-2
74-95-3
Acute Tox. 4
Details
201-557-4
84-74-2
Repr. 1B
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
R Toxic for reproduction (article 57c)
Details
220-481-2
2781-10-4
Muta. 2; Repr. 1B; STOT RE 1
Details
213-928-8
1067-33-0
Muta. 2; Repr. 1B; STOT RE 1
Details
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
R Toxic for reproduction (article 57c)
Details
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
Details
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
201-077-5
78-04-6
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Skin Corr. 1; Eye Dam. 1
Details
212-449-1
818-08-6
Muta. 2; Repr. 1B; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Eye Dam. 1
Details
217-635-6
1918-00-9
Acute Tox. 4; Eye Dam. 1
Details
214-787-5
1194-65-6
Acute Tox. 4
Details
202-564-5
97-17-6
Acute Tox. 4
Details
214-118-7
1085-98-9
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
204-210-5
117-80-6
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
Details
220-487-5
2782-57-2
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
Details
201-207-0
79-43-6
Skin Corr. 1A
Details
201-199-9
79-36-7
Skin Corr. 1A
Details
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
Details
222-583-2
3542-36-7
Repr. 1B; Acute Tox. 2; STOT RE 1
Details
200-838-9
75-09-2
Carc. 2
Details
202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
Details
204-390-5
120-36-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
D-2,4-DP; DICHLORPROP-P; DUPLOSAN DP-ACID
403-980-1
15165-67-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
Details
236-881-5
13530-68-2
C Carcinogenic (article 57a)
Details
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
C Carcinogenic (article 57a)
Details
620-436-0
75736-33-3
Eye Irrit. 2
Details
257-141-8
51338-27-3
Acute Tox. 4; Skin Sens. 1
Details
204-082-0
115-32-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Details
215-572-9
1332-65-6
Acute Tox. 4; Acute Tox. 3
Details
215-270-7
1317-39-1
Acute Tox. 4; Eye Dam. 1
Details
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
Details
205-494-3
141-66-2
Acute Tox. 2; Acute Tox. 3
Details
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
202-980-7
101-83-7
Acute Tox. 4; Skin Corr. 1B
Details
221-515-9
3129-91-7
Acute Tox. 4
Details
208-704-1
538-75-0
Acute Tox. 3; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
DCPMS; DYNASYLAN 9415; EURENOR 5023; SAN-30; WACKER SILAN CP2-DIMETHOXY; Z-6228
404-370-8
126990-35-0
Skin Irrit. 2; Eye Dam. 1
Details
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
Details
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
Details
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Details
258-526-3
53404-23-2
Acute Tox. 4
Details
SIFOSIL; SIFOSIL KONZENTRAT G 96-00 FEST
401-770-4
148324-78-1
Skin Corr. 1B; Acute Tox. 4
Details
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
Details
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details

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