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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 10 May 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
p-(1,1-Dimethylpropyl)phenol
201-280-9
80-46-6
yes
bis(α,α-dimethylbenzyl) peroxide
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
fenson (ISO); 4-chlorophenyl benzenesulphonate
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
chlorfenson (ISO); 4-chlorophenyl 4-chlorobenzenesulfonate
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
α, α-dimethylbenzyl hydroperoxide; cumene hydroperoxide
201-254-7
80-15-9
Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
dapsone; 4,4'-diamino diphenyl sulfone
201-248-4
80-08-0
Acute Tox. 4
chlorfenethol (ISO); 1,1-bis (4-chlorophenyl) ethanol
201-246-3
80-06-8
Acute Tox. 4
bisphenol A; 4,4'-isopropylidenediphenol
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
hexaconazole (ISO);(RS)-2-(2,4-dichlorophenyl)-1-(1H-1,2,4-triazol-1-yl)hexan-2- ol
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
3'-(3-acetyl-4-hydroxyphenyl)-1,1-diethylurea
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
(S)-2,3-dihydro-1H-indole-2-carboxylic acid
[S]-2-INDOLINE CARBOXYLIC ACID
410-860-2
79815-20-6
Repr. 2; STOT RE 2; Skin Sens. 1
tetramethylammonium hydrogen phthalate
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 2
fluazinam (ISO); 3-chloro-N-[3- chloro-2,6-dinitro-4-(trifluor omethyl)phenyl]-5-(trifluoromethyl)pyridin-2-amine
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
(1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine 2-hydroxy-2-phenylacetate
SERTRALINE STEP 2
420-560-3
79617-97-3
Eye Dam. 1
(3-aminophenyl)pyridin-3-ylmethanone
428-230-0
79568-06-2
STOT RE 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
diphenoxymethylenecyanamide
427-300-8
79463-77-7
Eye Dam. 1
3-chloro-5-trifluoromethyl-2- pyridylamine
ACTF; P-007
401-670-0
79456-26-1
Acute Tox. 4
methyl 3-isocyanatosulfonyl-2-thiophene-carboxylate
F7641; MTSI
410-550-7
79277-18-2
STOT RE 2; Resp. Sens. 1; Skin Sens. 1
fluazifop-P-butyl (ISO); butyl (R)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate
616-669-2
79241-46-6
Repr. 2
chrysoidine acetate; 4-(phenylazo)benzene-1,3-diamine acetate
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
(1R,4S)-2-azabicyclo[2.2.1]hept-5-en-3-one
1418U90
418-530-1
79200-56-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
7a-ethyl-3,5-bis(1-methylethyl)-2,3,4,5-tetrahydrooxazolo[3,4-c]-2,3,4,5-tetrahydrooxazole
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
2-nitropropane
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
dimethylcarbamoyl chloride
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
dichloroacetic acid
201-207-0
79-43-6
Skin Corr. 1A
methacrylic acid; 2-methylpropenoic acid
201-204-4
79-41-4
Acute Tox. 4; Skin Corr. 1A
dichloroacetyl chloride
201-199-9
79-36-7
Skin Corr. 1A
1,1,2,2-tetrachloroethane
201-197-8
79-34-5
Acute Tox. 2; Acute Tox. 1
L-(+)-lactic acid; (2S)-2-hydroxypropanoic acid
201-196-2
79-33-4
Skin Corr. 1C; Eye Dam. 1
isobutyric acid
201-195-7
79-31-2
Acute Tox. 4
isobutyryl chloride
201-194-1
79-30-1
Flam. Liq. 2; Skin Corr. 1A
2,3-dimethylbutane
201-193-6
79-29-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
1,1,2,2-tetrabromoethane
201-191-5
79-27-6
Acute Tox. 2; Eye Irrit. 2
nitroethane
201-188-9
79-24-3
Flam. Liq. 3; Acute Tox. 4
methyl chloroformate
201-187-3
79-22-1
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
peracetic acid . . . %
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
methyl acetate
201-185-2
79-20-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
N-methylacetamide
201-182-6
79-16-3
Repr. 1B
yes
chloroacetic acid
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
acrylic acid; prop-2-enoic acid
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
propionic acid ... %
201-176-3
79-09-4
Skin Corr. 1B
bromoacetic acid
201-175-8
79-08-3
Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1
2-chloracetamide
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
acrylamide; prop-2-enamide
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
chloroacetyl chloride
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
propionyl chloride
201-170-0
79-03-8
Flam. Liq. 2; Skin Corr. 1B
trichloroethylene; trichloroethene
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
1,1,2-trichloroethane
201-166-9
79-00-5
Carc. 2; Acute Tox. 4
methyl (3aR,4R,7aR)-2-methyl-4-(1S,2R,3-triacetoxypropyl)-3a,7a-dihydro-4H-pyrano[3,4-d]oxazole-6-carboxylate
GR138766X
415-670-3
78850-37-0
Eye Dam. 1
carbophenothion (ISO); 4-chlorophenylthiomethyl O, O-diethyl phosphorodithioate
212-324-1
786-19-6
Acute Tox. 3
4-(trans-4-propylcyclohexyl)acetophenone
4-(4-PROPYLCYCLOHEXYL)-ACETOPHENON
406-700-6
78531-61-0
Skin Sens. 1
1-(4-(trans-4-heptylcyclohexyl)phenyl) ethanone
4'-(4-HEPTYLCYCLOHEXYL)ACETOPHENONE
426-820-2
78531-60-9
Skin Sens. 1
1-(4-(trans-4-pentylcyclohexyl)phenyl)ethanone
4'-(4-PENTYLCYCLOHEXYL)ACETOPHENONE
426-830-7
78531-59-6
Skin Sens. 1
2-{4-(2-ammoniopropylamino)-6-[4-hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-2-aminopropyl formate
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
(±)-α-[(2-acetyl-5-methylphenyl)-amino]-2,6-dichlorobenzene-aceto-nitrile
T001769
419-290-9
780757-44-0
Skin Sens. 1
Hydrazine hydrate
616-584-0
7803-57-8
yes
phosphine
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
hydroxylamine ... % [> 55 % in aqueous solution];hydroxylamine ...% [≤ 55 % in aqueous solution]
232-259-2
7803-49-8
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
hydroxylamine ... % [> 55 % in aqueous solution];hydroxylamine ...% [≤ 55 % in aqueous solution]
232-259-2
7803-49-8
Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1-aminopropan-2-ol; isopropanolamine
201-162-7
78-96-6
Skin Corr. 1B
butanone; ethyl methyl ketone
201-159-0
78-93-3
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
propylenediamine
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
2,3-dichloropropene; 2,3-dichloropropylene
201-153-8
78-88-6
Flam. Liq. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
1,2-dichloropropane; propylene dichloride
201-152-2
78-87-5
Flam. Liq. 2; Carc. 1B; Acute Tox. 4
2-methylpropan-1-ol; iso-butanol
201-148-0
78-83-1
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
isoprene (stabilised); 2-methyl-1,3-butadiene
201-143-3
78-79-5
Flam. Liq. 1; Carc. 1B; Muta. 2
isopentane; 2-methylbutane
201-142-8
78-78-4
Flam. Liq. 1; Asp. Tox. 1; STOT SE 3
linalool; 3,7-dimethyl-1,6-octadien-3-ol; dl-linalool
201-134-4
78-70-6
Skin Sens. 1B
2,2'-dimethyl-2,2'-azodipropiononitrile; ADZN
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
3,5,5-trimethylcyclohex-2-enone; isophorone
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
menazon (ISO); S-[(4,6-diamino-1,3,5-triazin-2-yl)methyl] O, O-dimethyl phosphorodithioate
201-123-4
78-57-9
Acute Tox. 4
triethyl phosphate
201-114-5
78-40-0
Acute Tox. 4
dioxathion (ISO); 1,4-dioxan-2,3-diyl-O,O,O',O'-tetraethyl di(phosphorodithioate)
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [> 91 % solution];1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [≤ 91 % solution]
201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [> 91 % solution];1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [≤ 91 % solution]
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;[>20 % phlegmatiser]
201-084-3
78-11-5
Unst. Expl.
pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;[>20 % phlegmatiser]
201-084-3
78-11-5
Expl. 1.1
tetraethyl silicate; ethyl silicate
201-083-8
78-10-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
Tetraethyllead
201-075-4
78-00-2
yes
mono[2-(dimethylamino)ethyl]monohydrogen-2-(hexadec-2-enyl)butanedioate and/or mono[2-(dimethylamino)ethyl]monohydrogen-3-(hexadec-2-enyl)butanedioate
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sulphuryl chloride
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
ammonium perchlorate
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
chlorosulphonic acid
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
Sulfuric acid, cadmium salt (1:1), hydrate (3:8)
616-572-5
7790-84-3
yes
cadmium iodide
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
cadmium fluoride
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
Cadmium chloride, hydrate (2:5)
640-998-0
7790-78-5
yes
calcium hydride
232-189-2
7789-78-8
Water-react. 1
phosphorus tribromide
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
potassium bifluoride; potassium hydrogen difluoride
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
potassium fluoride
232-151-5
7789-23-3
Acute Tox. 3
fluorosulphonic acid
232-149-4
7789-21-1
Acute Tox. 4; Skin Corr. 1A
Sodium dichromate
616-541-6
7789-12-0
yes
ammonium dichromate
232-143-1
7789-09-5
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
strontium chromate
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
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
nickel sulfate
232-104-9
7786-81-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
mevinphos (ISO); 2-methoxycarbonyl-1-methylvinyl dimethyl phosphate
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2
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