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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
methyltriphenylphosphonium chloride
METHYL-TPP-CHLORID; MTPP-CHLORID
418-400-2
1031-15-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
metolcarb (ISO); m-tolyl methylcarbamate; MTMC
214-446-0
1129-41-5
Acute Tox. 4
metosulam (ISO); N-(2,6-dichloro-3-methylphenyl)-5,7-dimethoxy[1,2,4]triazolo[1,5-a] pyrimidine-2-sulfonamide
410-240-1
139528-85-1
Carc. 2; STOT RE 2
metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one; 4-amino-4,5-dihydro-6-(1,1-dimethylethyl)-3-methylthio-1,2,4-triazin-5-one
244-209-7
21087-64-9
Acute Tox. 4
mevinphos (ISO); 2-methoxycarbonyl-1-methylvinyl dimethyl phosphate
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
mexacarbate (ISO); 3,5-dimethyl-4-dimethylaminophenyl N-methylcarbamate
206-249-3
315-18-4
Acute Tox. 2; Acute Tox. 4
Microsporum spp.
-
-
F Fungi
milbemectin (ISO) [reaction mass of milbemycin A3 (CAS No 51596-10-2) and milbemycin A4 (CAS No 51596-11-3) (30:70)]
-
-
Acute Tox. 4
Milkers' node virus
-
-
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.
millerite
-
1314-04-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
Mineral wool, with the exception of those specified elsewhere in this Annex [Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content greater than 18 % by weight]
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Glass Wool EC / List no: - | CAS no: 308066-92-4
Glass, oxide, chemicals
This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
EC / List no: 266-046-0 | CAS no: 65997-17-3
-
-
Carc. 2
mipafox (ISO); N,N'-di-isopropylphosphorodiamidic fluoride
206-742-3
371-86-8
STOT SE 1
mix-cresol
215-293-2
1319-77-3
Acute Tox. 3; Skin Corr. 1B
mixed linear and branched C14-15 alcohols ethoxylated, reaction product with epichlorohydrin
NUPORE G45-10
420-480-9
158570-99-1
Skin Irrit. 2; Skin Sens. 1
molinate (ISO);S-ethyl 1-perhydroazepinecarbothioate; S-ethyl perhydroazepine-1-carbothioate
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
molybdenum nickel hydroxide oxide phosphate
268-585-7
68130-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
molybdenum nickel oxide
-
12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
molybdenum nickel tetraoxide
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
molybdenum trioxide
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
Monkeypox virus
-
-
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.
mono-2-[2-(4-dibenzo[b, f][1,4]thiazepin-11-yl)piperazinium-1-yl]ethoxy)ethanol trans-butenedioate
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 1
mono-methylamine;mono-methylamine ... %
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
mono-methylamine;mono-methylamine ... %
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
mono[2-(dimethylamino)ethyl]monohydrogen-2-(hexadec-2-enyl)butanedioate and/or mono[2-(dimethylamino)ethyl]monohydrogen-3-(hexadec-2-enyl)butanedioate
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
monoalkyl or monoaryl or monoalkyaryl esters of methacrylic acid with the exception of those specified elsewhere in this Annex
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
monoalkylor monoaryl or monoalkylaryl esters of acrylic acid with the exception of those specified elsewhere in this Annex
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
monobenzone; 4-hydroxyphenyl benzyl ether; hydroquinone monobenzyl ether
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
monocrotophos (ISO); dimethyl-1-methyl-2-(methylcarbamoyl)vinyl phosphate
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
monolinuron (ISO); 3-(4-chlorophenyl)-1-methoxy-1-methylurea
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
monosodium 3-cyano-5-fluoro-6-hydroxypyridine-2-olate
429-570-2
213990-58-0
Skin Sens. 1
monuron (ISO); 3-(4-chlorophenyl)-1,1-dimethylurea
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
Mopeia virus
-
-
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.
morfamquat (ISO); 1,1'-bis(3,5-dimethylmorpholinocarbonylmethyl)-4,4'-bipyridilium ion
-
7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
morfamquat dichloride
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
morfamquat sulfate
-
29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Morganella morganii
-
-
B Bacteria and similar species
morpholine
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
morpholine-4-carbonyl chloride
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
morphothion (ISO); O, O-dimethyl-S-(morpholinocarbonylmethyl) phosphorodithioate
205-628-0
144-41-2
Acute Tox. 3
Mucambo virus
-
-
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.
Mumps virus
-
-
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.
muscalure; cis-tricos-9-ene
248-505-7
27519-02-4
Skin Sens. 1B
musk ketone; 3,5-dinitro-2,6-dimethyl-4-tert-butylacetophenone; 4'-tert-butyl-2', 6'-dimethyl-3',; 5'-dinitroacetophenone
201-328-9
81-14-1
Carc. 2
musk xylene; 5-tert-butyl-2,4,6-trinitro-m-xylene
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
myclobutanil(ISO);2-(4-chlorophenyl)-2-(1H-1,2,4- triazol-1-ylmethyl)hexanenitrile
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
Mycobacterium africanum
-
-
B Bacteria and similar species
Mycobacterium avium/intracellulare
-
-
B Bacteria and similar species
Mycobacterium bovis (except BCG strain)
-
-
B Bacteria and similar species
Mycobacterium chelonae
-
-
B Bacteria and similar species
Mycobacterium fortuitum
-
-
B Bacteria and similar species
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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