EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). It 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).

RELEVANT LEGISLATION
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salts of benzidine

EC / List no: - CAS no: -
EU CLP (1272/2008)
Carc. 1A; Acute Tox. 4

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
(1,1'-Biphenyl)-4,4'-diamine, dihydriodide - 75534-79-1 Expert judgement
Disodium [5-[[4'-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulphophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]salicylato(4-)]cuprate(2-) 240-221-1 16071-86-6 Expert judgement
Benzidine acetate 252-984-8 36341-27-2 Expert judgement
benzidine, phosphate (1:1) - 66907-22-0 Expert judgement
Disodium 4-amino-3-[[4'-[(2,4-diamino-5-methylphenyl)azo][1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate 219-392-1 2429-83-6 Expert judgement
1,1'-Biphenyl-4,4'-diamine, monoperchlorate - 29806-76-6 Expert judgement
2,[?]-Naphthalenedisulfonic acid, 4-[[][[]4-[[](4-amino-1-naphthalenyl)azo]-1-naphthalenyl]azo]-, disodium salt 616-837-5 8004-59-9 Expert judgement
Trisodium 5-[[4'-[[8-amino-1-hydroxy-7-[(p-nitrophenyl)azo]-3,6-disulphonato-2-naphthyl]azo]-4-biphenyl]azo]salicylate 226-545-6 5422-17-3 Expert judgement
benzidine, mono(3,5-dinitrobenzoate) - 78577-08-9 Expert judgement
benzidine, bis(2-hydroxy-3,5-dinitrobenzoate) - 92415-34-4 Expert judgement
Benzidine dihydrochloride 208-519-6 531-85-1 Expert judgement
Disodium 8-[[4'-[(4-ethoxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-7-hydroxynaphthalene-1,3-disulphonate 222-560-7 3530-19-6 Expert judgement
Benzidine, hydrochloride - 14414-68-7 Expert judgement
Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 220-012-1 2602-46-2 Expert judgement
Disodium 5-[[4'-[(2-amino-8-hydroxy-6-sulphonato-1-naphthyl)azo][1,1'-biphenyl]-4-yl]azo]salicylate 219-393-7 2429-84-7 Expert judgement
Disodium 5-[[4'-[(1-amino-4-sulphonato-2-naphthyl)azo][1,1'-biphenyl]-4-yl]azo]salicylate 219-387-4 2429-79-0 Expert judgement
Disodium 5-[[4'-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphonatophenyl)-1H-pyrazol-4-yl]azo][1,1'-biphenyl]-4-yl]azo]salicylate 236-106-0 13164-93-7 Expert judgement
Disodium 7-hydroxy-8-[[4'-[[4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]naphthalene-1,3-disulphonate 222-655-3 3567-65-5 Expert judgement
benzidine, bis(3,5-dinitrobenzoate) - 92415-52-6 Expert judgement
(1,1'-Biphenyl)-4,4'-diamine, monoacetate - 52754-64-0 Expert judgement
3,3'-dichlorobenzidine 202-109-0 91-94-1 Expert judgement
Disodium 5-[[4'-[[2,4-diamino-5-[(4-sulphophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]salicylate 223-294-4 3811-71-0 Expert judgement
[1,1'-Biphenyl]-4,4'-diamine, perchlorate - 38668-12-1 Expert judgement
Disodium 5-[[4'-[[2,6-diamino-3-methyl-5-[(4-sulphonatophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-3-methylsalicylate 228-829-5 6360-54-9 Expert judgement
Disodium 4-amino-5-hydroxy-3-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-6-(phenylazo)naphthalene-2,7-disulphonate 222-835-1 3626-28-6 Expert judgement
4,4'-bi-o-toluidine 204-358-0 119-93-7 Expert judgement
(1,1'-Biphenyl)-ar,ar',4,4'-tetramine - 66836-18-8 Expert judgement
Disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate 217-710-3 1937-37-7 Expert judgement
Benzidine 202-199-1 92-87-5 Expert judgement (ECHA)
4,4'-bi-o-toluidine dihydrochloride 210-322-5 612-82-8 Expert judgement
3,3'-dichlorobenzidine dihydrochloride 210-323-0 612-83-9 Expert judgement
Disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) 209-358-4 573-58-0 Expert judgement
Disodium 5-[[4'-[[2,4-dihydroxy-3-[(4-sulphonatophenyl)azo]phenyl]azo][1,1'-biphenyl]-4-yl]azo]salicylate 220-768-2 2893-80-3 Expert judgement
Benzidine sulphate 244-236-4 21136-70-9 Expert judgement
Benzidine diperchlorate - 41195-21-5 Expert judgement
Disodium 4,4'-diaminobiphenyl-2,2'-disulfonate - 27336-24-9 Expert judgement
Nickel(2+), ((1,1'-biphenyl)-4,4'-diamine-N)- - 67632-50-2 Expert judgement
benzidine, mono(2-hydroxy-3,5-dinitrobenzoate) - 78577-03-4 Expert judgement
1,3,6-Naphthalenetrisulfonic acid, 8-hydroxy-7-((4'-((2-hydroxy-1-naphthalenyl)azo)-(1,1'-biph 613-540-2 6426-67-1 Expert judgement
Disodium 5-[[4'-[[1-hydroxy-7-(phenylamino)-3-sulphonato-2-naphthyl]azo][1,1'-biphenyl]-4-yl]azo]salicylate 222-450-9 3476-90-2 Expert judgement
Tetrasodium 5-[[4'-[[2,6-diamino-3-[[8-hydroxy-3,6-disulphonato-7-[(4-sulphonato-1-naphthyl)azo]-2-naphthyl]azo]-5-tolyl]azo][1,1'-biphenyl]-4-yl]azo]salicylate 219-390-0 2429-81-4 Expert judgement
[[1,1'-biphenyl]-4,4'-diyl]diammonium sulphate 208-520-1 531-86-2 Expert judgement
3,3'-dimethoxybenzidine 204-355-4 119-90-4 Expert judgement
Salts of benzidine - - Expert judgement (ECHA)
Disodium 5-[[4'-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo][1,1'-biphenyl]-4-yl]azo]salicylate 219-391-6 2429-82-5 Expert judgement
(1,1'-Biphenyl)-4,4'-diamine, monohydrochloride - 75752-15-7 Expert judgement
Hexasodium 5,5'-[(3,7-disulphonato-1,5-naphthylene)bis[azo(6-hydroxy-3,1-phenylene)azo[6(or 7)-sulphonato-4,1-naphthylene]azo[1,1'-biphenyl]-4,4'-diylazo]]bis(salicylate) 232-397-3 8014-91-3 Expert judgement
Tetrasodium 3,3'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 200-786-7 72-57-1 Expert judgement
Disodium 4-amino-5-hydroxy-6-[[4'-[(4-hydroxyphenyl)azo][1,1'-biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]naphthalene-2,7-disulphonate 224-376-2 4335-09-5 Expert judgement
Dipotassium O,O'-(4,4'-diaminobiphenyl-3,3'-ylene)diglycollate 277-771-7 74220-10-3 Expert judgement
[2,2'-dichloro[1,1'-biphenyl]-4,4'-diyl]diammonium sulphate 274-338-4 70146-07-5 Expert judgement
(1,1'-Biphenyl)-4,4'-diamine, dihydrofluoride - 41766-73-8 Expert judgement