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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 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
1-isopropyl-3-methylpyrazol-5-yl dimethylcarbamate; isolan
204-318-2
119-38-0
Acute Tox. 1; Acute Tox. 2
chlormephos (ISO); S-chloromethyl O,O-diethyl phosphorodithioate
246-538-1
24934-91-6
Acute Tox. 1; Acute Tox. 2
demeton
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
demeton-O (ISO); O,O-diethyl-O-2-ethylthioethyl phosphorothioate
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
demeton-S (ISO); diethyl-S-2-ethylthioethyl phosphorothioate
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
dimefox (ISO); tetramethylphosphorodiamidic fluoride
204-076-8
115-26-4
Acute Tox. 1; Acute Tox. 2
dimethyl 4-(methylthio)phenyl phosphate
620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
disulfoton (ISO); O,O-diethyl 2-ethylthioethyl phosphorodithioate
206-054-3
298-04-4
Acute Tox. 1; Acute Tox. 2
fensulfothion (ISO); O,O-diethyl O-4-methylsulfinylphenyl phosphorothioate
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
fluenetil (ISO); 2-fluoroethyl biphenyl-4-ylacetate
-
4301-50-2
Acute Tox. 1; Acute Tox. 2
fonofos (ISO); O-ethyl phenyl ethylphosphonodithioate
213-408-0
944-22-9
Acute Tox. 1; Acute Tox. 2
fosthietan (ISO); diethyl 1,3-dithietan-2-ylidenephosphoramidate
244-437-7
21548-32-3
Acute Tox. 1; Acute Tox. 2
isobenzan (ISO); 1,3,4,5,6,7,8,8-octachloro-1,3,3a,4,7,7a-hexahydro-4,7-methanoisobenzofuran
206-045-4
297-78-9
Acute Tox. 1; Acute Tox. 2
mephosfolan (ISO); diethyl 4-methyl-1,3-dithiolan-2-ylidenephosphoramidate
213-447-3
950-10-7
Acute Tox. 1; Acute Tox. 2
mevinphos (ISO); 2-methoxycarbonyl-1-methylvinyl dimethyl phosphate
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
O-ethyl O-4-nitrophenyl phenylphosphonothioate; EPN
218-276-8
2104-64-5
Acute Tox. 1; Acute Tox. 2
phorate (ISO); O,O-diethyl ethylthiomethyl phosphorodithioate
206-052-2
298-02-2
Acute Tox. 1; Acute Tox. 2
phosacetim (ISO); O,O-bis(4-chlorophenyl) N-acetimidoylphosphoramidothioate
223-874-7
4104-14-7
Acute Tox. 1; Acute Tox. 2
phosfolan (ISO); diethyl 1,3-dithiolan-2-ylidenephosphoramidate
213-423-2
947-02-4
Acute Tox. 1; Acute Tox. 2
prothoate (ISO); O,O-diethyl isopropylcarbamoylmethyl phosphorodithioate
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
schradan (ISO); octamethylpyrophosphoramide
205-801-0
152-16-9
Acute Tox. 1; Acute Tox. 2
strychnine
200-319-7
57-24-9
Acute Tox. 1; Acute Tox. 2
sulfotep (ISO); O, O,O, O-tetraethyl dithiopyrophosphate
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
tefluthrin (ISO); 2,3,5,6-tetrafluoro-4-methylbenzyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate
616-699-6
79538-32-2
Acute Tox. 1; Acute Tox. 2
TEPP (ISO); tetraethyl pyrophosphate
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
terbufos (ISO); S-tert-butylthiomethyl O, O-diethylphosphorodithioate
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
thiofanox (ISO); 3,3-dimethyl-1-(methylthio)butanone-O-(N-methylcarbamoyl)oxime
254-346-4
39196-18-4
Acute Tox. 1; Acute Tox. 2
thionazin (ISO); O,O-diethyl O-pyrazin-2-yl phosphorothioate
206-049-6
297-97-2
Acute Tox. 1; Acute Tox. 2
triamiphos (ISO); 5-amino-3-phenyl-1,2,4-triazol-1-yl-N, N,N',N'-tetramethylphosphonic diamide
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
IPSP; S-ethylsulphinylmethyl O,O-diisopropylphosphorodithioate
-
5827-05-4
Acute Tox. 1; Acute Tox. 3
1-(3,4-dichlorophenylimino); thiosemicarbazide
-
5836-73-7
Acute Tox. 2
3-(3-amino-5-(1-methylguanidino)-1-oxopentylamino-6-(4-amino-2-oxo-2,3-dihydro-pyrimidin-1-yl)-2,3-dihydro-(6H)-pyran-2-carboxylic acid; blasticidin-s
606-640-2
2079-00-7
Acute Tox. 2
[(dimethylsilylene)bis((1,2,3,3a,7a-η)-1H-inden-1-ylidene)dimethyl]hafnium
M1
422-060-0
137390-08-0
Acute Tox. 2
aconitine
206-121-7
302-27-2
Acute Tox. 2
atropine
200-104-8
51-55-8
Acute Tox. 2
brucine nitrate
227-317-9
5786-97-0
Acute Tox. 2
brucine sulphate
225-432-9
4845-99-2
Acute Tox. 2
brucine; 2,3-dimethoxystrychnine
206-614-7
357-57-3
Acute Tox. 2
bufa-4,20,22-trienolide, 6-(acetyloxy)-3-(β-D-glucopyranosyloxy)-8,14-dihydroxy-, (3β, 6β)-; red squill; scilliroside
208-077-4
507-60-8
Acute Tox. 2
calcium cyanide
209-740-0
592-01-8
Acute Tox. 2
carbofuran (ISO); 2,3-dihydro-2,2-dimethylbenzofuran-7-yl N-methylcarbamate
216-353-0
1563-66-2
Acute Tox. 2
crimidine (ISO);2-chloro-6-methylpyrimidin-4- yldimethylamine
208-622-6
535-89-7
Acute Tox. 2
cyfluthrin (ISO); α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;α-cyano-4-fluoro-3-phenoxybenzyl-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; beta-cyfluthrin
269-855-7
68359-37-5
Acute Tox. 2
fluoroacetates, soluble
-
-
Acute Tox. 2
fluoroacetic acid
205-631-7
144-49-0
Acute Tox. 2
hyoscyamine
202-933-0
101-31-5
Acute Tox. 2
methomyl (ISO); 1-(methylthio)ethylideneamino N-methylcarbamate
240-815-0
16752-77-5
Acute Tox. 2
nicotine (ISO); 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine
200-193-3
54-11-5
Acute Tox. 2
physostigmine
200-332-8
57-47-6
Acute Tox. 2
pilocarpine
202-128-4
92-13-7
Acute Tox. 2
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