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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 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
sodium cyanate
213-030-6
917-61-3
Acute Tox. 4
sodium chromate
231-889-5
7775-11-3
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
sodium chlorate
231-887-4
7775-09-9
Ox. Sol. 1; Acute Tox. 4
sodium carbonate
207-838-8
497-19-8
Eye Irrit. 2
sodium bifluoride; sodium hydrogen difluoride
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
sodium benzoyloxybenzene-4-sulfonate
LU20
405-450-5
66531-87-1
Skin Sens. 1
sodium azide
247-852-1
26628-22-8
Acute Tox. 2
sodium and potassium 4-(3-aminopropylamino)-2,6-bis[3(4-methoxy-2-sulfophenylazo)4-hydroxy-2-sulfo-7-naphthylamino]-1,3,5-triazine
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
sodium [29H,31H-phthalocyaninato-(2-)-N29,N30,N31,N32]-((3-(N-methyl-N-(2-hydroxyethyl)amino)propyl)amino)sulfonyl-sulfonato, copper complex
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
sodium 5-n-butylbenzotriazole
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
sodium 5-[2-chloro-4-(trifluoromethyl) phenoxy]-2-nitrobenzoate; acifluorfen-sodium
263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
sodium 4-sulfophenyl-6-((1-oxononyl)amino)hexanoate
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
sodium 4-hydroxy-3-(N'-(2-(2-hydroxyethylenesulfonyl)ethylene)ureido)-5-nitrobenzenesulfonate
425-460-3
1379676-84-2
Skin Sens. 1
sodium 4-chloro-1-hydroxybutane-1-sulfonate
BISULPHITE ADDUCT; GR59658A
406-190-5
54322-20-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
sodium 4-[4-(4-hydroxyphenylazo)phenylamino]-3-nitrobenzenesulfonate
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
sodium 4-(4-chloro-6-(N-ethylanilino)-1,3,5-triazin-2-ylamino)-2-(1-(2-chlorophenyl)-5-hydroxy-3-methyl-1H-pyrazol-4-ylazo)benzenesulfonate
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
sodium 4-(2,4,4-trimethylpentylcarbonyloxy)benzenesulfonate
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
sodium 3-nitrobenzenesulphonate
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
sodium 3-chloroacrylate
-
4312-97-4
Acute Tox. 4
sodium 3-acetoacetylamino-4-methoxytolyl-6-sulfonate
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
sodium 3-(methoxycarbonyl)-4-oxo-3,4,5,6-tetrahydro-2-pyridinolate
418-410-7
139122-78-4
Eye Irrit. 2
sodium 3-(2H-benzotriazol-2- yl)-5-sec-butyl-4-hydroxyben zenesulfonate
BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
403-080-9
92484-48-5
Eye Dam. 1
sodium 3-(2-acetamido-4-(4-(2-hydroxybutoxy)phenylazo)phenylazo)benzenesulfonate
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
sodium 3,5-dichloro-2-(5-cyano-2,6-bis(3-hydroxypropylamino)-4-methylpyridin-3-ylazo)benzenesulphonate
H: SÄUREGELB 2829
401-870-8
115035-41-1
Eye Dam. 1
sodium 3,5-bis(tetradecyloxycarbonyl)benzenesulfinate
AF-390
407-720-8
155160-86-4
Skin Sens. 1
sodium 3,5-bis(3-(2,4-di-tert-pentylphenoxy)propylcarbamoyl)benzenesulfonate
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
sodium 2-ethylhexanolate
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
sodium 2-biphenylate; 2-phenylphenol, sodium salt
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
sodium 2-benzoyloxy-1-hydroxyethane-sulfonate
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
sodium 2-anilino-5-(2-nitro-4-(N-phenylsulfamoyl))anilinobenzenesulfonate
NSGBB; YELLOW BROWN E-GLN
412-320-1
31361-99-6
Eye Dam. 1
sodium 2-[[4-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]phenyl]sulfonyl]ethyl sulfate
430-890-1
81992-66-7
Skin Sens. 1
sodium 2-(nonanoyloxy)benzenesulfonate
434-360-9
91125-43-8
Eye Dam. 1; Skin Sens. 1
sodium 2-(4-(4-fluoro-6-(2-sulfo-ethylamino)-[1,3,5]triazin-2-ylamino)-2-ureido-phenylazo)-5-(4-sulfophenylazo)benzene-1-sulfonate
FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538
410-770-3
146177-84-6
Skin Sens. 1
sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethonolate; sodium dehydracetate
224-580-1
4418-26-2
Acute Tox. 4
sodium 1,2-bis[4-[4-{4-(4-sulfophenylazo)-2-sulfophenylazo}-2-ureido-phenyl-amino]-6-fluoro-1,3,5-triazin-2-ylamino]-propane, sodium salt
REACTIVE ORANGE TZ 3931
413-990-8
149850-31-7
Skin Sens. 1
sodium 1,1,2,2,3,3,4,4,4-nonafluoro-1-butanesulfinate
422-100-7
102061-82-5
Eye Dam. 1; Skin Sens. 1
sodium (Z)-3-chloro-3-(4-chlorophenyl)-1-hydroxy-2-propene-1-sulfonate
420-800-7
1379804-37-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sodium (R)-2-(2,4-dichlorophenoxy)propionate
DUPLOSAN-DP-NATRIUM; DUPOLSON-DP-NATRIUM
413-340-3
119299-10-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sodium (n-butyl)x(ethyl)y-1,5-dihydro)aluminate x = 0,5 y =1,5
EURESYNTH(R) 5010
418-720-2
-
Flam. Sol. 1; Water-react. 1; Pyr. Sol. 1; Acute Tox. 4; Skin Corr. 1A
sodium (6R-trans)-7-amino-8-oxo-3-[[[1-(sulfomethyl)-1H-tetrazol-5-yl]thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monohydrate
426-520-1
71420-85-4
Skin Sens. 1
sodium (1-(5-(4-(4-anilino-3-sulphophenylazo)-2-methyl-5-methylsulphonamidophenylazo)4-hydroxy-2-oxido-3-(phenylazo)phenylazo)-5-nitro-4-sulphonato-2-naphtholato)iron(II)
SÄUREBRAUN 6230
401-220-3
-
Acute Tox. 4
sodium (1,0-1,95)/lithium (0,051) 5-((5-((5-chloro-6-fluoro-pyrimidin-4-yl)amino)-2-sulfonatophenyl)azo)-1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxo-3-pyridinemethylsulfonate
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
sodium ((N-(3-trimethylammoniopropyl)sulfamoyl)methylsulfonatophthalocyaninato)copper(II)
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
sodium
231-132-9
7440-23-5
Water-react. 1; Skin Corr. 1B
slimes and sludges, copper electrolytic refining, decopperised, nickel sulfate
Product obtained from recycling of the end electrolyte of copper refining electrolysis followed by evaporation to separate the residual sulfuric acid. Consists primarily of nickel and iron sulfates with small amounts of the sulfates of zinc, alkali earths and alkali metals.
295-859-3
92129-57-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
slimes and sludges, copper electrolyte refining, decopperised
Substance obtained as a powdery cathodic precipitate during the electrolytic decoppering stage of copper refining electrolysis. Consists primarily of copper with antimony, arsenic, lead and nickel in metallic form as well as oxides and sulfates.
305-433-1
94551-87-8
Carc. 1A; Muta. 2; Repr. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Slack wax (petroleum); Slack wax [A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
265-165-5
64742-61-6
Carc. 1B
Slack wax (petroleum), low-melting; Slack wax [A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-524-1
92062-10-7
Carc. 1B
Slack wax (petroleum), low-melting, silicic acid-treated; Slack wax [A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-158-5
97863-06-4
Carc. 1B
Slack wax (petroleum), low-melting, hydrotreated; Slack wax [A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predomi nantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.]
A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-525-7
92062-11-8
Carc. 1B
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