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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Last updated 03 May 2024. Database contains 4917 unique substances/entries.
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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
 
monoalkyl or monoaryl or monoalkylaryl esters of acrylic acid with the exception of those specified elsewhere in this Annex
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
Mopeia virus
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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
Morganella morganii
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B Bacteria and similar species
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Mucambo virus
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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
Mumps virus
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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.
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Mycobacterium africanum
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B Bacteria and similar species
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Mycobacterium avium/intracellulare
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B Bacteria and similar species
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Mycobacterium bovis (except BCG strain)
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B Bacteria and similar species
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Mycobacterium chelonae
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B Bacteria and similar species
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Mycobacterium fortuitum
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B Bacteria and similar species
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Mycobacterium kansasii
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B Bacteria and similar species
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Mycobacterium leprae
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B Bacteria and similar species
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Mycobacterium malmoense
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B Bacteria and similar species
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Mycobacterium marinum
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B Bacteria and similar species
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Mycobacterium microti
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B Bacteria and similar species
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Mycobacterium paratuberculosis
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B Bacteria and similar species
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Mycobacterium scrofulaceum
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B Bacteria and similar species
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Mycobacterium simiae
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B Bacteria and similar species
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Mycobacterium szulgai
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B Bacteria and similar species
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Mycobacterium tuberculosis
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B Bacteria and similar species
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Mycobacterium ulcerans
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B Bacteria and similar species
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Mycobacterium xenopi
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B Bacteria and similar species
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Mycoplasma caviae
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B Bacteria and similar species
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Mycoplasma hominis
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B Bacteria and similar species
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Mycoplasma pneumoniae
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B Bacteria and similar species
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N-hexadecyl(or octadecyl)-N-hexadecyl (or octadecyl)benzamide
DTBA
401-980-6
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Skin Irrit. 2; Skin Sens. 1
Details
Naegleria fowleri
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P Parasites
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Ndumu virus
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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
Necator americanus
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P Parasites
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Neisseria gonorrhoeae
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B Bacteria and similar species
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Neisseria meningitidis
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B Bacteria and similar species
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Neotestudina rosatii
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F Fungi
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Newcastle disease virus
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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
Nocardia asteroides
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B Bacteria and similar species
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Nocardia brasiliensis
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B Bacteria and similar species
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Nocardia farcinica
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B Bacteria and similar species
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Nocardia nova
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B Bacteria and similar species
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Nocardia otitidiscaviarum
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B Bacteria and similar species
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Nonylphenol, ethoxylated (10-EO)
931-755-2
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
Nonylphenol, ethoxylated (10-EO) (9016-45-9)
939-993-9
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
Nonylphenol, ethoxylated (15-EO)
931-756-8
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
Nonylphenol, ethoxylated (6,5-EO)
931-753-1
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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Nonylphenol, ethoxylated (8-EO)
931-754-7
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
Nonylphenol, ethoxylated (EO = 4)
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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Nonylphenol, ethoxylated (polymer)
938-618-6
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
Nonylphenolpolyglycolether
932-998-7
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
Norwalk virus
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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
O'nyong-nyong virus
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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
o-dianisidine based azo dyes; 4,4'-diarylazo-3,3'-dimethoxybiphenyl dyes with the exception of those mentioned elsewhere in this Annex
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2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] EC / List no: 229-920-2 | CAS no: 6837-37-2
5,5'-diphenyl-3,3'-bis(4-nitrophenyl)-2,2'-(3,3'-dimethoxybiphenyl-4,4'-ylene)ditetrazolium dichloride EC / List no: 206-067-4 | CAS no: 298-83-9
1-Naphthalenesulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(4-hydroxy-, lithium salt (1:2) EC / List no: - | CAS no: 75673-34-6
1-Naphthalenesulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(4-hydroxy-, lithium sodium salt (1:1:1) EC / List no: - | CAS no: 75673-35-7
Copper, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(5-amino-4-hydroxy-2,7-naphthalenedisulfonate) morpholine ammonium lithium sodium complexes EC / List no: - | CAS no: 96591-22-9
5,5'-(3,3'-Dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(1-(4-nitrophenyl)-3-phenylformazan) EC / List no: - | CAS no: 63469-14-7
2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chlorophenyl)-3-oxobutyramide] EC / List no: 241-469-3 | CAS no: 17453-73-5
Benzoic acid, 4,4'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl(2-acetyl-1-oxo-2,1-ethanediyl)imino))bis-, 1,1'-dibutyl ester EC / List no: - | CAS no: 820212-95-1
3,3'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[2,5-bis(p-nitrophenyl)-2H-tetrazolium] dichloride EC / List no: 214-665-1 | CAS no: 1184-43-6
3,3'-dihydroxy-N,N'-(3,3'-dimethoxybiphenyl-4,4'-diyl)di-2-naphthamide EC / List no: 202-108-5 | CAS no: 91-92-9
2,7-Naphthalenedisulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(5-amino-4-hydroxy-, lithium sodium salt (1:3:1) EC / List no: - | CAS no: 75752-17-9
Disodium 2,2'-[(3,3'-dimethoxy-4,4'-biphenylylene)bis[azo(methylimino)]]di(ethanesulphonate) EC / List no: 241-085-6 | CAS no: 17011-51-7
Butanamide, 2,2'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(N-(chlorophenyl)-3-oxo- EC / List no: - | CAS no: 72845-99-9
Tetrasodium 2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[azo(2-amino-5-hydroxy-7-sulphonato-6,1-naphthylene)azo]]bis[5-nitrobenzoate] EC / List no: 274-429-9 | CAS no: 70210-33-2
2-Naphthalenecarboxamide, N,N'-(3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(3-hydroxy-, disodium salt EC / List no: - | CAS no: 52735-88-3
4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-hydroxy-N-phenylnaphthalene-2-carboxamide] EC / List no: 233-354-1 | CAS no: 10127-03-4
4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one] EC / List no: 229-389-7 | CAS no: 6505-29-9
6,6'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-amino-5-hydroxynaphthalene-1,3-disulphonic] acid EC / List no: 223-333-5 | CAS no: 3841-14-3
Tetralithium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] EC / List no: 275-603-7 | CAS no: 71550-22-6
N,N'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[3-oxobutyramide] EC / List no: 223-873-1 | CAS no: 4104-12-5
Tetrasodium 4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-hydroxynaphthalene-2,7-disulphonate] EC / List no: 265-533-5 | CAS no: 65151-33-9
Tetrasodium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-(acetylamino)-4-hydroxynaphthalene-2,7-disulphonate] EC / List no: 267-711-8 | CAS no: 67906-44-9
3,3'-(3,3'-dimethoxy-4,4'-biphenylene)bis(2,5-diphenyl-2H-tetrazolium) chloride EC / List no: 217-488-8 | CAS no: 1871-22-3
2,7-Naphthalenedisulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(5-amino-4-hydroxy-, lithium sodium salt (1:1:3) EC / List no: - | CAS no: 75659-72-2
2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide] EC / List no: 229-388-1 | CAS no: 6505-28-8
3,3'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[5-[4-(aminothioxomethyl)phenyl]-2-(p-nitrophenyl)-2H-tetrazolium] dichloride EC / List no: 253-257-8 | CAS no: 36889-43-7
2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide] EC / List no: 230-458-9 | CAS no: 7147-42-4
Disodium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis(4-hydroxynaphthalene-1-sulphonate) EC / List no: 219-382-7 | CAS no: 2429-71-2
3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)diazo]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, sodium salt, compound with 2,2'-iminodiethanol EC / List no: 273-433-8 | CAS no: 68966-43-8
2,7-Naphthalenedisulfonic acid, 3,3'-((3,3'-dimethoxy(1,1'-biphenyl)-4,4'-diyl)bis(2,1-diazenediyl))bis(5-amino-4-hydroxy-, lithium sodium salt (1:2:2) EC / List no: - | CAS no: 75659-73-3
Disodium 4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[iminocarbonyl(2-hydroxy-4,1-phenylene)azo]]bis(3-hydroxynaphthalene-1-sulphonate) EC / List no: 274-498-5 | CAS no: 70247-69-7
4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one] EC / List no: 229-986-2 | CAS no: 6883-91-6
4,4'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide] EC / List no: 226-614-0 | CAS no: 5437-88-7
Tetrasodium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] EC / List no: 219-385-3 | CAS no: 2429-74-5
3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)diazo]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, sodium salt EC / List no: 273-439-0 | CAS no: 68966-50-7
Tetrasodium 3,3'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydroxynaphthalene-2,7-disulphonate] EC / List no: 224-091-3 | CAS no: 4198-19-0
Tetrasodium 6,6'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-amino-5-hydroxynaphthalene-1,3-disulphonate] EC / List no: 220-026-8 | CAS no: 2610-05-1
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Carc. 1B
Details
o-tolidine based dyes; 4,4'-diarylazo-3,3'-dimethylbiphenyl dyes, with the exception of those mentioned elsewhere in this Annex
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2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] EC / List no: 268-048-7 | CAS no: 67990-27-6
N,N'-(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[3-oxobutyramide], disodium salt EC / List no: 271-328-1 | CAS no: 68540-94-3
N,N'-(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(3-hydroxynaphthalene-2-carboxamide) EC / List no: 223-007-2 | CAS no: 3692-05-5
2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide] EC / List no: 228-789-9 | CAS no: 6358-88-9
Disodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-diamino-5-methylbenzenesulphonate] EC / List no: 229-024-1 | CAS no: 6405-94-3
N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide) EC / List no: 202-111-1 | CAS no: 91-96-3
2,2'-[(3,3'-dimethyl-4,4'-biphenylylene)bis(azo)]bis[4-(1,1,3,3-tetramethylbutyl)phenol] EC / List no: 230-616-7 | CAS no: 7218-82-8
3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bis[bis(3-aminopropyl)(p-methoxybenzyl)methylammonium] dichloride EC / List no: 255-154-3 | CAS no: 40948-42-3
Disodium 3,3'-((3,3'-dimethyl(1,1'-biphenyl)-4,4'-diyl)bis(azo)bis(4-aminonaphthalene-1-sulphonate) EC / List no: 213-594-3 | CAS no: 992-59-6
N,N'-(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[2-[(2,4-dichlorophenyl)azo]-3-oxobutyramide] EC / List no: 227-783-3 | CAS no: 5979-28-2
Benzamide, 3,3'-((3,3'-dimethyl(1,1'-biphenyl)-4,4'-diyl)bis(imino(1-acetyl-2-oxo-2,1-ethanediyl)-2,1-diazenediyl))bis(4-methyl- EC / List no: - | CAS no: 64441-14-1
Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] EC / List no: 200-786-7 | CAS no: 72-57-1
Tetrasodium 6,6'-((3,3'-dimethyl-(1,1'-biphenyl-4,4'diyl)bis(azo)bis(4-amino-5-hydroxy-1,3-naphthalenedisulphonate) EC / List no: 206-242-5 | CAS no: 314-13-6
Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydroxynaphthalene-2,7-disulphonate] EC / List no: 218-432-5 | CAS no: 2150-54-1
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Carc. 1B
Details
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