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).

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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU REACH: List of SVHC
EU_BA Directive 2000/54/EC
 
4,4'-thiodianiline and its salts
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
Details
4-(4-amino-3-methylphenyl)-2-methylaniline;dihydrochloride
210-322-5
612-82-8
Carc. 1B; Acute Tox. 4
Details
4-(4-amino-3-methylphenyl)-2-methylaniline;sulfuric acid
277-985-0
74753-18-7
Carc. 1B; Acute Tox. 4
Details
6-methoxy-m-toluidine; p-cresidine
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
C Carcinogenic (article 57a)
Details
calcium chromate
237-366-8
13765-19-0
Carc. 1B; Acute Tox. 4
Details
hydrazobenzene; 1,2-diphenylhydrazine
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
Details
nitrosodipropylamine
210-698-0
621-64-7
Carc. 1B; Acute Tox. 4
Details
salts of 2,2'-dichloro-4,4'-methylenedianiline; salts of 4,4'-methylenebis(2-chloroaniline)
-
-
Carc. 1B; Acute Tox. 4
Details
salts of 3,3'-dimethoxybenzidine; salts of o-dianisidine
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[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(2-hydroxy-3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-49-1
(1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, sulfate EC / List no: - | CAS no: 56436-30-7
(1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, monohydrochloride EC / List no: - | CAS no: 111984-09-9
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-38-8
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(2-hydroxy-3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-48-0
3,3'-dimethoxybiphenyl-4,4'-ylenediammonium dichloride EC / List no: 243-737-5 | CAS no: 20325-40-0
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(3,5-dinitrobenzoate) EC / List no: - | CAS no: 92415-53-7
-
-
Carc. 1B; Acute Tox. 4
Details
salts of 4,4'-bi-o-toluidine; salts of 3,3'-dimethylbenzidine; salts of o-tolidine
-
-
Carc. 1B; Acute Tox. 4
Details
strontium chromate
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
C Carcinogenic (article 57a)
Details
sulfallate (ISO); 2-chloroallyl N, N-dimethyldithiocarbamate
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
Details
N,N-dimethyl-p-toluidine
202-805-4
99-97-8
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT RE 2
Details
butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime
202-496-6
96-29-7
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3; STOT SE 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
C.I. Basic Violet 3 with ≥ 0,1 % of Michler's ketone (EC no.202-027-5);C.I. Basic Violet 3; 4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride;[4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride; C.I. Basic Violet 3
208-953-6
548-62-9
Carc. 1B; Acute Tox. 4; Eye Dam. 1
Details
styrene oxide;(epoxyethyl)benzene; phenyloxirane
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
Details
1-methyl-3-nitro-1-nitrosoguanidine
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
thioacetamide
200-541-4
62-55-5
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing < 0,1 % 4-chloroaniline (EC No 203-401-0)];1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing ≥ 0,1 % 4-chloroaniline (EC No 203-401-0)]
433-580-2
214353-17-0
Carc. 1B; Acute Tox. 4; Skin Corr. 1B
Details
hydrazine bis(3-carboxy-4-hydroxybenzensulfonate)
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
3,3'-dichlorobenzidine; 3,3'-dichlorobiphenyl-4,4'-ylenediamine
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
Details
4,4'-methylenedi-o-toluidine
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
C Carcinogenic (article 57a)
Details
4-amino-3-fluorophenol
FAP
402-230-0
399-95-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
Details
salts of 3,3'-dichlorobenzidine; salts of 3,3'-dichlorobiphenyl-4,4'-ylenediamine
-
-
Carc. 1B; Acute Tox. 4; Skin Sens. 1
Details
(6-(4-hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazin-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
Details
2,2-bis(bromomethyl)propane-1,3-diol
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
Details
Anthracene oil, anthracene paste, anthracene fraction; Anthracene Oil Fraction [A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330 °C to 350 °C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.]
A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-275-9
91995-15-2
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
Anthracene oil, anthracene paste, carbazole fraction; Anthracene Oil Fraction [A complex combination of hydrocarbons from the distil lation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350 °C to 360 °C (662°F to 680 °F). It contains chiefly anthracene, carbazole and phenanthrene.]
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
Details
Anthracene oil, anthracene paste, distn. lights; Anthracene Oil Fraction [A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290 °C to 340 °C (554°F to 644 °F). It contains chiefly trinuclear aromatics and their dihydro derivatives.]
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
295-278-5
91995-17-4
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
Anthracene oil, anthracene paste; Anthracene Oil Fraction [The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.]
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
Anthracene oil, anthracene-low; Anthracene Oil Fraction [The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.]
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
C Carcinogenic (article 57a)
M Mutagen (article 57b)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
Aromatic hydrocarbons, C6-10, C8-rich; Light Oil Redistillate, low boiling
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
Details
Aromatic hydrocarbons, C8-9, hydrocarbon resin polymn. by-product; Light Oil Redistillate, high boiling [A complex combination of hydrocarbons obtained from the evaporation of solven under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120 o C to 215 o C (248 °F to 419 °F).]
A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120°C to 215°C (248°F to 419°F).
295-281-1
91995-20-9
Carc. 1B; Muta. 1B
Details
Aromatic hydrocarbons, C8; Light Oil Redistillate, high boiling
292-694-9
90989-38-1
Carc. 1B; Muta. 1B
Details
Aromatic hydrocarbons, C9-12, benzene distn.; Light Oil Redistillate, high boiling
295-551-9
92062-36-7
Carc. 1B; Muta. 1B
Details
Benzol forerunnings (coal); Light Oil Redistillate, low boiling [The distillate from coke oven light oil having an approximate distillation range below 100 o C (212 °F). Composed primarily of C4 to C6 aliphatic hydrocarbons.]
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), benzole fraction, BTX-rich; Light Oil Redistillate, low boiling [A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75 °C to 200 °C (167 °F to 392 °F).]
A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C (167°F to 392°F).
309-984-9
101896-26-8
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), benzole fraction, distn. residues; Wash Oil [A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300 °C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70 °C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.]
A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300°C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70°C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.
310-165-3
121620-46-0
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), light oils, acid exts.; Light Oil Extract Residues, high boiling [This oil is a complex reaction mass of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m- and p-cresol and boiling in the range of 140o C to 215o C (284 °F to 419 °F).]
This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m-, and p-cresol and boiling in the range of 140°C to 215°C (284°F to 419°F).
292-609-5
90640-87-2
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), light oils, alk. exts.; Alkaline Extract [The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]
The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-610-0
90640-88-3
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), light oils, neutral fraction; Light Oil Extract Residues, high boiling [A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135o C to 210o C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135°C to 210°C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.
309-971-8
101794-90-5
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), light oils; Carbolic Oil [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 o C to 210 o C (302 °F to 410 °F).]
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
Distillates (coal tar), naph thalene oils, naphthalene-low; Naphthalene Oil Redistillate [A complex combination of hydrocarbons obtained by crys tallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.]
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
Distillates (coal tar), naphthalene oil crystn. mother liquor; Naphthalene Oil Redistillate [A complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200 °C to 230 °C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.]
A complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.
295-310-8
91995-49-2
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), naphthalene oils, acid exts.; Methylnaphthalene Oil Extract Residue [A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230 °C to 255 °C (446°F to 491°F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.]
A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230°C to 255°C (446°F to 491°F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.
295-309-2
91995-48-1
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), naphthalene oils, alk. exts.; Alkaline Extract [The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]
The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-611-6
90640-89-4
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), naphthalene oils, indole-methylnaphthalene fraction; Methylnaphthalene Oil [A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235 °C to 255 °C (455 °F to 491 °F).]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235°C to 255°C (455°F to 491°F).
309-972-3
101794-91-6
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), naphthalene oils, methylnaphthalene fraction; Methylnaphthalene Oil [A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225 °C to 255 °C (437°F to 491 °F).]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225°C to 255°C (437°F to 491°F).
309-985-4
101896-27-9
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), naphthalene oils, naphthalene-free, alk. exts.; Naphthalene Oil Extract Residue [The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.]
The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.
292-612-1
90640-90-7
Carc. 1B; Muta. 1B
Details
Distillates (coal tar), naphthalene oils; Naphthalene Oil [A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compound and aromatic nitrogen compounds and distills in the approximate range of 200 °C to 250 °C (392°F to 482°F).]-
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
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