EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 26 April 2024. Database contains 4821 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
Mycobacterium kansasii
-
-
B Bacteria and similar species
Mycobacterium leprae
-
-
B Bacteria and similar species
Mycobacterium malmoense
-
-
B Bacteria and similar species
Mycobacterium marinum
-
-
B Bacteria and similar species
Mycobacterium microti
-
-
B Bacteria and similar species
Mycobacterium paratuberculosis
-
-
B Bacteria and similar species
Mycobacterium scrofulaceum
-
-
B Bacteria and similar species
Mycobacterium simiae
-
-
B Bacteria and similar species
Mycobacterium szulgai
-
-
B Bacteria and similar species
Mycobacterium tuberculosis
-
-
B Bacteria and similar species
Mycobacterium ulcerans
-
-
B Bacteria and similar species
Mycobacterium xenopi
-
-
B Bacteria and similar species
Mycoplasma caviae
-
-
B Bacteria and similar species
Mycoplasma hominis
-
-
B Bacteria and similar species
Mycoplasma pneumoniae
-
-
B Bacteria and similar species
N'-(1,3-dimethylbutylidene)-3-hydroxy-2-naphthohydrazide
435-860-1
214417-91-1
Skin Sens. 1
N, N''-(methylenedi-4,1-phenylene)bis[N'-(4-methylphenyl)urea]
429-380-1
133336-92-2
Skin Sens. 1
N, N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea
445-760-8
-
Eye Dam. 1; Resp. Sens. 1
N, N',N''-tris(2-methyl-2,3-epoxypropyl)-perhydro-2,4,6-oxo-1,3,5-triazine
435-010-8
26157-73-3
Muta. 2
N, N'-(2,2-dimethylpropylidene)hexamethylenediamine
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
N, N'-bis(trifluoroacetyl)-S, S'-bis-L-homocysteine
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
N, N'-diphenyl-p-phenylenediamine; N, N'-diphenyl-1,4-benzenediamine
200-806-4
74-31-7
Skin Sens. 1
N, N'-ethylenebis(vinylsulfonylacetamide)
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
N, N,N',N'-tetramethyl-3,3'-(propylenebis(iminocarbonyl-4,1-phenylenazo(1,6-dihydro-2-hydroxy-4-methyl-6-oxopyridine-3,1-diyl)))di(propylammonium) dilactate
CARTASOL BRILLIANT YELLOW K-6G; CARTASOL BRILLIANT YELLOW K-6G CONC.; GIALLO BRILLANTE CARTASOL K-6G CONC.; JAUNE BRILLANT CARTASOL K-RWA 3904; RWA 3904
403-340-1
164578-09-0
Eye Dam. 1
N, N,N',N'-tetramethyl-p-phenylenediamine
202-831-6
100-22-1
Acute Tox. 4
N, N,N',N'-tetramethyldithiobis(ethylene)diamine dihydrochloride
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
N, N,N',N'-tetramethylethylenediamine
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
N, N-(dimethylamino)thioacetamide hydrochloride
435-470-1
27366-72-9
Repr. 1B
N, N-bis(2-(p-toluenesulfonyloxy)ethyl)-p-toluenesulfonamide
DIETHANOLAMIN-TRITOSYLAT
412-920-3
16695-22-0
Skin Sens. 1
N, N-bis(2-ethylhexyl)-((1,2,4- triazol-1-yl)methyl)amine
CM 23-376; REOMET 30
401-280-0
91273-04-0
Skin Corr. 1B; Skin Sens. 1
N, N-bis(3-aminopropyl)methylamine
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
N, N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
N, N-dibutyl-(2,5-dihydro-5-thioxo-1H-tetrazol-1-yl)acetamide
418-290-6
168612-06-4
Eye Irrit. 2; Skin Sens. 1
N, N-diethyl-N',N'-dimethylpropan-1,3-diyl-diamine
DDPD
406-610-7
62478-82-4
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
N, N-dimethyl-2-(3-(4-chloro phenyl)-4,5-dihydropyrazol-1- ylphenylsulphonyl)ethylamine
HOSTALUX VP 3481
401-410-6
10357-99-0
STOT RE 2; Skin Sens. 1
N, N-dimethylanilinium tetrakis(pentafluorophenyl)borate
B1; N,N-DIMETHYLANILINUM TETRAKIS(PENTAFLUOROPHENYL)BORATE; TÉTRAKIS(PENTAFLUOROPHÉNYL)BORATE DE N,N-DIMÉTHYLANILINIUM
422-050-6
118612-00-3
Carc. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
N, N-dimethylformamide; dimethyl formamide
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
N, N-hydrazinodiacetic acid
F.H.D.A.
403-510-5
19247-05-3
Acute Tox. 3; STOT RE 2; Skin Sens. 1
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
Acute Tox. 4; Eye Irrit. 2
N,N'-bis{6-chloro-4-[6-(4-vinylsulfonylphenylazo)-2,7-disulfonicacid-5-hydroxynapht-4-ylamino]-1,3,5-triazin-2-yl}-N-(2-hydroxyethyl)ethane-1,2-diamine, sodium salt
RED REN 363
419-500-9
171599-85-2
Eye Dam. 1; Skin Sens. 1
N,N'-diacetylbenzidine
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
N,N'-dihexadecyl-N,N'-bis(2-hydroxyethyl)propanediamide
QUESTAMIDE H
422-560-9
149591-38-8
Repr. 2; Eye Irrit. 2
N,N'-dimethylbenzidine
-
2810-74-4
Acute Tox. 4
N,N'-methylenedimorpholine; N,N'-methylenebismorpholine [formaldehyde released from N,N'-methylenebismorpholine]; [MBM]
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
N,N'—1,6-hexanediylbis(N-(2,2,6,6-tetramethyl-piperidin-4-yl)-formamide
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
Eye Irrit. 2
N,N,N',N'-tetraglycidyl-4,4'-diamino-3,3'-diethyldiphenylmethane
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
N,N,N',N'-tetramethyl-4,4'-methylendianiline
202-959-2
101-61-1
Carc. 1B
yes
N,N,N,N-tetrakis(4,6-bis(butyl- (N-methyl-2,2,6,6-tetramethyl piperidin-4-yl)amino)triazin-2- yl)-4,7-diazadecane-1,10- diamine
CHIMASSORB 119; LOWILITE 19
401-990-0
106990-43-6
Skin Sens. 1
N,N,N-trimethylanilinium chloride
205-319-0
138-24-9
Acute Tox. 3
N,N-bis(cocoyl-2-oxypropyl)-N,N-dibutylammonium bromide
431-530-4
1380226-29-8
Skin Corr. 1A; Skin Sens. 1
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