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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 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
potassium 2-chloro-3-(benzyloxy)propionate
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
potassium 2-hydroxycarbazole-1-carboxylate
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
potassium 3,6-dichloro-o-anisate
233-002-7
10007-85-9
Eye Irrit. 2
potassium 3-iodo-6-methylbenzenesulfonate
426-300-5
-
Eye Dam. 1
potassium 4-(11-methacrylamidoundecanamido)benzenesulfonate
V67282
406-500-9
174393-75-0
Skin Sens. 1
potassium 4-iodo-2-sulfonato-benzoic acid
426-620-5
619297-89-1
Eye Dam. 1
potassium bifluoride; potassium hydrogen difluoride
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
potassium bis(N-carboxymethyl)-N-methyl-glycinato-(2-)N, O,O, N)-ferrate-(1-)monohydrate
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
potassium bromate
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
potassium chlorate
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
potassium chromate
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
potassium cyanate
209-676-3
590-28-3
Acute Tox. 4
potassium dichromate
231-906-6
7778-50-9
Ox. Sol. 2; 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
potassium ethanolate; potassium ethoxide
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
potassium ferrite
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
potassium fluoride
232-151-5
7789-23-3
Acute Tox. 3
potassium hydrogensulphate
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
potassium hydroxide; caustic potash
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
Potassium hydroxyoctaoxodizincatedichromate
234-329-8
11103-86-9
yes
potassium iron(III) 1,3-propanediamine-N, N,N',N'-tetraacetate hemihydrate
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
potassium methanolate; potassium methoxide
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
potassium mu-fluoro-bis(triethylaluminium)
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
potassium N-(1-methoxy-1-oxobut-2-en-3-yl)valinate
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
potassium N-(4-fluorophenyl)glycinate
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
potassium N-(4-toluenesulfonyl)-4-toluenesulfonamide
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
potassium nitrite
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
potassium pentachlorophenolate
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
potassium perchlorate
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
Potassium perfluorohexane-1-sulphonate
223-393-2
3871-99-6
yes
potassium perfluorooctanesulfonate; potassium heptadecafluorooctane-1-sulfonate
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
potassium permanganate
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
potassium polysulphides
253-390-1
37199-66-9
Skin Corr. 1B
potassium salt of DNOC; potassium 4,6-dinitro-o-cresolate
-
5787-96-2
Acute Tox. 3; STOT RE 2
potassium sodium 3,3'-(3(or 4)-methyl-1,2-phenylenebis(imino(6-chloro)-1,3,5-triazine-4,2-diylimino(2-acetamido-5-methoxy)-4,1-phenylenazo)dinaphthalene-1,5-disulfonate
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
potassium sodium 4-(4-chloro-6-(3,6-disulfonato-7-(5,8-disulfonato-naphthalen-2-ylazo)-8-hydroxy-naphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-(2-sulfatoethanesulfonyl)-phenylazo)-naphthalene-1,7-disulfonate
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
potassium sodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulphonato-6-(2-sulphonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-ylamino) phenyl-N-methyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulphonatophenylazo)naphthalene-2,7-disulphonat
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
potassium tetrasodium bis[(N,N'-n)-1'-(phenylcarbamoyl)-3,5-disulfonatobenzeneazo-1'-prop-1'-ene-2,2'-diolato]chromate(III)
425-830-4
-
Eye Dam. 1
Potassium titanium oxide(K2Ti6O13)
432-240-0
12056-51-8
Carc. 2
potassium, sodium 2,4-diamino-3-[4-(2-sulfonatoethoxysulfonyl)phenylazo]-5-[4-(2-sulfonatoethoxysulfonyl)-2-sulfonatophenylazo]-benzenesulfonate
ORANGE DER 8068
422-980-2
187026-95-5
Eye Dam. 1
Powassan
-
-
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.
prallethrin (ISO); ETOC; 2-methyl-4-oxo-3-(prop-2-ynyl)cyclopent-2-en-1-yl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
245-387-9
23031-36-9
Acute Tox. 3; Acute Tox. 4
Prevotella spp.
-
-
B Bacteria and similar species
prochloraz (ISO);N-propyl-N-[2-(2,4,6-trichlorop henoxy)ethyl]-1H-imidazole-1- carboxamide
266-994-5
67747-09-5
Acute Tox. 4
product by process iron complex of azo dyestuffs obtained by coupling a mixture of diazotized 2-amino-1-hydroxybenzene-4-sulfanilide and 2-amino-1-hydroxybenzene-4-sulfonamide with resorcin, the obtained mixture being subsequently submitted to a second coupling reaction with a mixture of diazotized 3-aminobenzene-1-sulfonic acid (metanilic acid) and 4'-amino-4-nitro-1,1'-diphenylamine-2-sulfonic acid and metallization with ferric chloride, sodium salt
BROWN JR 547
419-260-5
-
Eye Dam. 1
product-by-process definition polyazodyestuff obtained by coupling 4-[4-(1-amino-8-hydroxy-3,6-disulfo-2-naphthylazo)phenylsulfonylamino] benzenediazonium with reaction mass of 4-carboxybenzenediazonium and diphenylamine-3-sulfo-4,4'-bisdiazonium, and further coupling of the obtained compounds with reaction mass of naphth-2-ol and 3-aminophenol, sodium salts; sodium chloride
425-740-5
-
Eye Dam. 1
profenofos (ISO)O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
255-255-2
41198-08-7
Acute Tox. 4
profluralin (ISO);N-(cyclopropylmethyl)-α, α,α- trifluoro-2,6-dinitro-N-propyl-p-toluidine
247-656-6
26399-36-0
Eye Irrit. 2
profoxydim (ISO); 2-{(EZ)-1-[(2RS)-2-(4-chlorophenoxy)propoxyimino]butyl}-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
promecarb (ISO); 3-isopropyl-5-methylphenyl N-methylcarbamate
220-113-0
2631-37-0
Acute Tox. 3
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