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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 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
N,N-diethyl-m-toluamide; deet
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
N,N-diethylaniline
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
N,N-dimethyl-m-toluidine
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
N,N-dimethyl-o-toluidine
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
N,N-dimethyl-p-toluidine
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
N,N-dimethylacetamide
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
N,N-dimethylaniline
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
N,N-dimethylbenzene-1,3-diamine
220-623-3
2836-04-6
Acute Tox. 3
N,N-dimethylhydrazine
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
N-(1,3-dimethylbutyl)-N'-(phenyl)-1,4-benzoquinonediimine
429-640-2
52870-46-9
Eye Irrit. 2
N-(2',6'-dimethylphenyl)-2-piperidinecarboxamide hydrochloride
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
N-(2,2,6,6-tetramethyl-1-oxylpiperidin-4-yl)acetamide; (4-acetamido-2,2,6,6-tetra; methyl-1-piperidinyl)oxidanyl
423-840-3
14691-89-5
Acute Tox. 4
N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate; 4-(N-ethyl-N-2-methanesulphonylaminoethyl)-2-methylphenylenediamine sesquisulphate monohydrate
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
N-(2-(6-ethyl-7-(4-methylphenoxy)-1H-pyrazolo[1,5-b][1,2,4]triazol-2-yl)propyl)-2-octadecyloxybenzamide
UM-229
407-070-5
142859-67-4
Skin Sens. 1
N-(2-amino-4,6-dichloropyrimidin-5-yl)formamide
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
N-(4-(3-(4-cyanophenyl)ureido)-3-hydroxyphenyl)-2-(2,4-di-tert-pentylphenoxy)octanamide
UC-129
403-790-9
108673-51-4
Skin Sens. 1
N-(5-chloro-3-((4-(diethylamino)-2-methylphenyl)imino-4-methyl-6-oxo-1,4-cyclohexadien-1-yl)benzamide
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
N-(dichlorofluoromethylthio)phthalimide; N-(fluorodichloromethylthio)phthalimide
211-952-3
719-96-0
Skin Irrit. 2
N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
N-(n-octyl)-2-pyrrolidone
NOP; SURFADONE LP-100 SURFACTANT
403-700-8
2687-94-7
Skin Corr. 1B
N-2-naphthylaniline; N-phenyl-2-naphthylamine
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
N-[(benzotriazole-1-yl)methyl)]4-carboxy-benzenesulfonamide
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
N-[1-(S)-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-N-carboxyanhydride
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
N-[2-(3-acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl]acetamide
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
N-[2-hydroxy-3-(C12-16-alkyloxy)propyl]-N-methyl glycinate
DS 100
415-060-7
1379678-87-1
Eye Dam. 1; Skin Sens. 1
N-[3-(1,1-dimethylethyl)-1H-pyrazol-5-yl]-N'-hydroxy-4-nitrobenzenecarboximidamide
423-530-8
152828-23-4
STOT RE 1; Acute Tox. 4
N-[3-[(2-acetyloxy)ethyl](phenyl-methyl)amino]-4-methoxyphenylacetamide
BENZANILID-DISPERSE-INTERMEDIATE ZP 9955
411-590-8
70693-57-1
Skin Corr. 1B
N-[4-cyano-3-trifluoromethylphenyl]methacrylamide
427-880-2
90357-53-2
STOT RE 2
N-[6,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6-oxo-1H-purin-2-yl]acetamide
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
N-amidino-N-methylglycine-2-oxopropionate
429-120-5
208535-04-0
Eye Dam. 1
N-benzyl-N-ethyl-(4-(5-nitro-benzo[c]isothiazol-3-ylazo)phenyl)amine
425-300-2
186450-73-7
Skin Sens. 1
n-butyl acetate
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
n-butyl acrylate
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
n-butyl methacrylate
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
n-butyl propionate
209-669-5
590-01-2
Flam. Liq. 3
N-butyl-2-(4-morpholinylcarbonyl)benzamide
EP 389
407-730-2
104958-67-0
Eye Irrit. 2; Skin Sens. 1
N-butyl-3-(2-chloro-4-nitrophenylhydrazono)-1-cyano-2-methylprop-1-ene-1,3-dicarboximide
DISPERSOL YELLOW XF
407-970-8
75511-91-0
Skin Sens. 1
n-butyronitrile
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
N-carboxymethyliminobis(ethylenenitrilo)tetra (acetic acid)
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
N-cyclohexyl-S, S-dioxo; benzo[b]tiophene-2-carboxamide
PREVENTOL VP OC 3061
423-990-1
149118-66-1
Acute Tox. 4; Eye Dam. 1
N-cyclohexylbenzothiazole-2- sulphenamide
202-411-2
95-33-0
Skin Sens. 1
N-dodecyl-[3-(4-(dimethylamino)benzamido)-propyl]dimethylammonium tosylate
DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE
421-130-8
156679-41-3
Eye Dam. 1; Skin Sens. 1
N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one
220-250-6
2687-91-4
Repr. 1B
N-ethyl-3-trimethoxysilyl-2-methyl-propanamine
437-720-3
227085-51-0
Eye Dam. 1
N-ethyl-N-methylpiperidinium iodide
CATALYST 4017
407-780-5
4186-71-4
Acute Tox. 4
N-ethylaniline
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
N-hexadecyl(or octadecyl)-N-hexadecyl (or octadecyl)benzamide
DTBA
401-980-6
-
Skin Irrit. 2; Skin Sens. 1
n-hexane
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
n-hexyllithium
N-HEXYLLITHIUM
404-950-0
21369-64-2
Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
N-isopropyl-N'-phenyl-p-phenylenediamine
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
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