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 12 travnja 2024. Database contains 4917 unique substances/entries.
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616-541-6
7789-12-0
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
Details
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
Details
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
Details
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
Details
616-572-5
7790-84-3
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
Details
626-360-4
15244-35-6
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
Details
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
Details
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
Details
616-699-6
79538-32-2
Acute Tox. 1; Acute Tox. 2
Details
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
Details
604-715-4
149979-41-9
Carc. 2; Repr. 2
Details
606-566-0
20487-40-5
Flam. Liq. 2
Details
682-362-5
12527-76-3
Acute Tox. 4
Details
601-147-9
111988-49-9
Carc. 2; Repr. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3
Details
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
Details
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
Details
604-237-6
141517-21-7
Lact.; Skin Sens. 1
Details
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
603-146-9
126535-15-7
Carc. 2
Details
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
Details
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
Details
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
Details
604-291-0
142469-14-5
Skin Sens. 1
Details
610-700-3
51580-86-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
Details
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
Details
607-955-8
2655-14-3
Acute Tox. 4
Details
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
Details
605-037-1
156052-68-5
Skin Sens. 1
Details
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3
Details
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
Details
701-394-3
1782069-81-1
END Endocrine disrupting properties (Article 57(f) - human health)
Details
701-225-3
1101132-67-5
Carc. 2; Repr. 2; STOT RE 2
Details
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2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
799-970-2
-
R Toxic for reproduction (article 57c)
Details
701-118-1
2156592-54-8
Repr. 1B; Eye Irrit. 2
Details
701-162-1
-
Repr. 1B
Details
701-271-4
-
Repr. 1B; Eye Irrit. 2
Details
701-376-5
1372804-76-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
700-242-3
62037-80-3
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
Details
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Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
799-973-9
-
R Toxic for reproduction (article 57c)
Details
UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17
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Alkanes, C14-17, chloro EC / List no: 287-477-0 | CAS no: 85535-85-9
di-, tri- and tetrachlorotetradecane EC / List no: 950-299-5 | CAS no: -
Alkanes, C14-16, chloro EC / List no: 701-376-5 | CAS no: 1372804-76-6
Tetradecane, chloro derivs. EC / List no: - | CAS no: 198840-65-2
799-971-8
-
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
Details
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Phenol, methylstyrenated EC / List no: 270-966-8 | CAS no: 68512-30-1
700-960-7
-
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
Details
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
Details
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Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
799-972-3
-
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
701-468-5
21049-36-5
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
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Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
799-976-5
-
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
822-682-6
1417782-03-6
Skin Sens. 1
Details
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
Details

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