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 29 svibnja 2024. Database contains 4917 unique substances/entries.
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201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
Details
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
616-932-1
8011-63-0
Acute Tox. 4; Eye Dam. 1
Details
620-359-2
8065-36-9
Acute Tox. 3
Details
212-668-2
842-07-9
Carc. 2; Muta. 2; Skin Sens. 1
Details
232-283-3
8001-35-2
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
Details
201-599-3
85-34-7
Acute Tox. 4
Details
201-246-3
80-06-8
Acute Tox. 4
Details
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
Details
282-714-4
84332-86-5
Carc. 2
Details
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
281-549-5
83968-67-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
282-432-1
84196-22-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
ARGOLD; CINMETHYLIN; WL 95481
402-410-9
87818-31-3
Acute Tox. 4
Details
617-258-0
81777-89-1
Acute Tox. 4
Details
201-378-1
81-82-3
STOT RE 2
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
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
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
Details
201-248-4
80-08-0
Acute Tox. 4
Details
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
Details
212-758-1
867-27-6
Acute Tox. 3
Details
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
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
212-449-1
818-08-6
Muta. 2; Repr. 1B; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Eye Dam. 1
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
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
201-559-5
84-75-3
Repr. 1B
R Toxic for reproduction (article 57c)
Details
201-553-2
84-69-5
Repr. 1B
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
201-861-7
88-85-7
Repr. 1B; Acute Tox. 3; Eye Irrit. 2
R Toxic for reproduction (article 57c)
Details
201-434-5
82-66-6
Acute Tox. 2; STOT RE 1
Details
-
83-59-0
Acute Tox. 3; Acute Tox. 4
Details
201-579-4
85-00-7
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
Details
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150°C to 210°C (302°F to 410°F).
283-483-2
84650-03-3
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by crystallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.
284-898-1
84989-09-3
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills in the approximate range of 200°C to 250°C (392°F to 482°F).
283-484-8
84650-04-4
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.
284-899-7
84989-10-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from coal tar. It consists of aromatic and polycyclic hydrocarbons, primarily fluorene and acenaphthene.
284-900-0
84989-11-7
Carc. 1B
Details
The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148°C (298°F).
285-076-5
85029-51-2
Carc. 1B; Muta. 1B
Details
A complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 160°C to 180°C (320°F to 356°F).
285-509-8
85116-58-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to C25 and boiling in the range of approximately 205° C to 400°C (401°F to 752°F).
285-505-6
85116-53-6
Carc. 1B
Details
CA 875 B
414-450-4
88805-65-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
ETHOFENPROX; TREBON
407-980-2
80844-07-1
Lact.
Details
CINEOLE ALCOHOL
402-470-6
87172-89-2
Acute Tox. 4; Eye Dam. 1
Details
The extract oil boiling in the range of approximately 220°C to 265°C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.
284-901-6
84989-12-8
Carc. 1B; Muta. 1B
Details
283-972-0
84776-45-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
Details

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