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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
glutamic acid, reaction products with N-(C12-14-alkyl)propylenediamine
EW 400; GLUCOPROTAMIN
403-950-8
164907-72-6
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
glutaral; glutaraldehyde; 1,5-pentanedial
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
yes
glyoxal...%; ethandial...%
203-474-9
107-22-2
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
glyphosate (ISO); N-(phosphonomethyl)glycine
213-997-4
1071-83-6
Eye Dam. 1
guazatine (ISO)
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-1-methyl-1H-pyrazole-4-carboxylate
600-130-3
100784-20-1
Repr. 1B
heazlewoodite
-
12035-71-1
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
heptachlor epoxide; 2,3-epoxy-1,4,5,6,7,8,8-heptachloro-3a,4,7,7a-tetrahydro-4,7-methanoindane
213-831-0
1024-57-3
Carc. 2; Acute Tox. 3; STOT RE 2
heptan-2-one; methyl amyl ketone
203-767-1
110-43-0
Flam. Liq. 3; Acute Tox. 4
heptan-3-one; butyl ethyl ketone
203-388-1
106-35-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2
heptan-4-one; di-n-propyl ketone
204-608-9
123-19-3
Flam. Liq. 3; Acute Tox. 4
heptane; n-heptane
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
heptanoic acid
203-838-7
111-14-8
Skin Corr. 1B
hexachloroacetone
204-129-5
116-16-5
Acute Tox. 4
hexachlorobenzene
204-273-9
118-74-1
Carc. 1B; STOT RE 1
hexachloroplatinic acid
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
hexafluoropropene; hexafluoropropylene
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
hexahydro-4-methylphthalic anhydride
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexakis(tetramethylammonium) 4,4'-vinylenebis((3-sulfonato-4,1-phenylene)imino(6- morpholino-1,3,5-triazine-4,2- diyl)imino)bis(5-hydroxy-6-phenylazonaphthalene-2,7- disulfonate)
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
hexamethylene diacrylate; hexane-1,6-diol diacrylate
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hexamethylenediamine
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
hexan-1-ol
203-852-3
111-27-3
Acute Tox. 4
hexane (containing < 5 % n-hexane (203-777-6)); 2-methylpentane
203-523-4
107-83-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
hexasodium (di[N-(3-(4-[5-(5-amino-3-methyl-1-phenylpyrazol-4-yl-azo)-2,4-disulfo-anilino]-6-chloro-1,3,5-triazin-2-ylamino)phenyl)-sulfamoyl](di-sulfo)-phthalocyaninato)nickel
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
hexasodium 4,4'-dihydroxy-3,3'-bis[2-sulfonato-4-(4-sulfonatophenylazo)phenylazo]-7,7'[p-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]dinaphthalene-2-sulfonate
RED SF-PE 3534
410-180-6
157627-99-1
Eye Dam. 1
hexasodium tungstate hydrate
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
hydrazine bis(3-carboxy-4-hydroxybenzensulfonate)
STABO-FIX
405-030-1
148434-03-1
Carc. 1B; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
hydrazobenzene; 1,2-diphenylhydrazine
204-563-5
122-66-7
Carc. 1B; Acute Tox. 4
hydriodic acid ... %;hydrogen iodide
233-109-9
10034-85-2
Skin Corr. 1B
hydriodic acid ... %;hydrogen iodide
233-109-9
10034-85-2
Press. Gas; Skin Corr. 1A
hydrobromic acid ... %;hydrogen bromide
233-113-0
10035-10-6
Press. Gas; Skin Corr. 1A; STOT SE 3
hydrobromic acid ... %;hydrogen bromide
233-113-0
10035-10-6
Skin Corr. 1B; STOT SE 3
Hydrocarbon oils, arom., mixed with polyethylene and polypropylene, pyrolyzed, light oil fraction; Heat Treatment Products [he oil obtained from the heat treatment of a polyethylene/ polypropylene reaction mass with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70 °C to 120 °C (158 °F to 248 °F).]
The oil obtained from the heat treatment of a polyethylene/polypropylene mixture with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 120°C (158°F to 248°F).
309-745-9
100801-63-6
Carc. 1B; Muta. 1B
Hydrocarbon oils, arom., mixed with polyethylene, pyrolyzed, light oil fraction; Heat Treatment Products [he oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70 °C to 120 °C (158°F to 248°F).]
The oil obtained from the heat treatment of polyethylene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of 70°C to 120°C (158°F to 248°F).
309-748-5
100801-65-8
Carc. 1B; Muta. 1B
Hydrocarbon oils, arom., mixed with polystyrene, pyrolyzed, light oil fraction; Heat Treatment Products [he oil obtained from the heat treatment of polystyrene with coal tar pitch or aromatic oils.; It consists predominantly of benzene and its homologs boiling in a range of approximately 70 °C to 210 °C (158 °F to 410°F).]
The oil obtained from the heat treatment of polystyrene with coal tar pitch or aromatic oils. It consists predominantly of benzene and its homologs boiling in a range of approximately 70°C to 210°C (158°F to 410°F).
309-749-0
100801-66-9
Carc. 1B; Muta. 1B
Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by distillation of steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly C5.]
A complex combination of hydrocarbons obtained by distillation of steam-cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly C5.
310-012-0
102110-14-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C5-rich, dicyclopentadiene-contg.; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by distillation of the products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers of C5 and dicyclopentadiene and boiling in the range of approximately 30o C to 170o C (86°F to 338°F).]
A complex combination of hydrocarbons obtained by distillation of the products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers of C5 and dicyclopentadiene and boiling in the range of approximately 30°C to 170°C (86°F to 338°F).
310-013-6
102110-15-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C6-8, hydrogenated sorption-dearomatized, toluene raffination; Low boiling point naphtha — unspecified [ complex combination of hydrocarbons obtained during the sorptions of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80o C to 135o C (176°F to 275°F).]
A complex combination of hydrocarbons obtained during the sorptions of toluene from a hydrocarbon fraction from cracked gasoline treated with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80°C to 135°C (176°F to 275°F).
309-870-9
101316-66-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined; Low boiling point modified naphtha [ complex combination of hydrocarbons obtained by distillation of hydrotreated naphtha followed by solvent extraction. It consists predominantly of saturated hydrocarbons and boiling in the range of approximately 65o C to 70o C (149°F to 158°F).]
A complex combination of hydrocarbons obtained by distillation of hydrotreated naphtha followed by solvent extraction. It consists predominantly of saturated hydrocarbons and boiling in the range of approximately 65°C to 70°C (149°F to 158°F).
309-871-4
101316-67-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C8-12, catalytic cracker distillates; Low boiling point cat-cracked naphtha [ complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approxi mately 140 °C to 210 °C (284°F to 410°F).]
A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140°C to 210°C (284°F to 410°F).
309-974-4
101794-97-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Hydrocarbons, C8-12, catalytic cracking, chem. neutralized, sweetened; Low boiling point cat-cracked naphtha
309-987-5
101896-28-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
hydrogen
215-605-7
1333-74-0
Flam. Gas 1; Press. Gas
hydrogen sodium N-carboxylatoethyl-N-octadec-9-enylmaleamate
2-BUTANEDIOIC ACID, MONOAMIDE WITH N-(9-OCTADECENYL)-3-AMINO
402-970-4
148292-42-6
Skin Sens. 1
hydroxo(2-(benzenesulfonamido)benzoato)zinc(II)
SICORIN E 10197
403-750-0
113036-91-2
Acute Tox. 4
hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
641-410-5
130066-44-3
Skin Sens. 1A
hydroxylamine dihydrogenphos; phate
242-818-2
19098-16-9
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hydroxylammonium hydrogensulfate; hydroxylamine sulfate(1:1)
233-154-4
10046-00-1
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hydroxylammonium nitrate
236-691-2
13465-08-2
Expl. 1.1; Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
hymexazol (ISO);3-hydroxy-5-methylisoxazole
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
hyoscyamine
202-933-0
101-31-5
Acute Tox. 2
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