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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid
601-305-7
114311-32-9
Repr. 2
imidacloprid (ISO); (E)-1-(6-chloro-3-pyridylmethyl)-N-nitroimidazolidin-2-ylideneamine; (2E)-1-[(6-chloropyridin-3-yl) methyl]-N-nitroimidazolidin-2-imine
428-040-8
138261-41-3
Acute Tox. 3
imidazo[1,2-b]pyridazin hydrochloride
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
indoxacarb (ISO); methyl (4aS)-7-chloro-2-{(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]carbamoyl}-2,5-dihydroindeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
ioxynil (ISO) 4-hydroxy-3,5-diiodobenzonitrile
216-881-1
1689-83-4
Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol
-
115850-69-6
Repr. 1B; Acute Tox. 4; STOT RE 2
ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol
-
115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
iprovalicarb (ISO); isopropyl [(2S)-3-methyl-1-{[1-(4-methylphenyl)ethyl]amino}-1-oxobutan-2-yl]carbamate
604-209-3
140923-17-7
Carc. 2
isobutyl 3,4-epoxybutyrate
IVAX
401-920-9
100181-71-3
Skin Irrit. 2; Skin Sens. 1
isobutyl acetate
203-745-1
110-19-0
Flam. Liq. 2
isobutyl acrylate
203-417-8
106-63-8
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
isobutylidene-(2-(2-isopropyl-4,4-dimethyloxazolidine-3-yl)-1,1-dimethylethyl)amine
ZOLDINE RD-4
419-850-2
148348-13-4
Skin Corr. 1B
isobutylisopropyldimethoxysilane
ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
402-580-4
111439-76-0
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
Isononylphenol
234-284-4
11066-49-2
yes
isopentyl acetate
204-662-3
123-92-2
Flam. Liq. 3
isopentyl formate
203-769-2
110-45-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
isopentyl propionate
203-322-1
105-68-0
Flam. Liq. 3
isopropyl acetate
203-561-1
108-21-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
isopropyl chloroacetate
203-301-7
105-48-6
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
isopropylammonium 2-(3-benzoylphenyl)propionate
417-970-1
1379932-74-7
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1
isostearic acid monoisopropanolamide
431-540-9
170573-32-7
Skin Irrit. 2
isoxaflutole (ISO); 5-cyclopropyl-1,2-oxazol-4-yl α,α,α-trifluoro-2-mesyl-p-tolyl ketone
604-222-4
141112-29-0
Repr. 2
isoxathion (ISO); O,O-diethyl O-5-phenylisoxazol-3-ylphosphorothioate
242-624-8
18854-01-8
Acute Tox. 3
Kerosine (petroleum), hydrotreated; Kerosine — unspecified [ complex combination of hydrocarbons obtained from the distillation of petroleum and subsequent hydrotreatment. It consists predominantly of alkanes, cycloalkanes and alkylbenzenes having carbon numbers predominantly in the range of C12 through C16 and boiling in the range of approximately 230 °C to 270 °C (446 °F to 518 °F).]
A complex combination of hydrocarbons obtained from the distillation of petroleum and subsequent hydrotreatment. It consists predominantly of alkanes, cycloalkanes and alkylbenzenes having carbon numbers predominantly in the range of C12 through C16 and boiling in the range of approximately 230°C to 270°C (446°F to 518°F).
309-944-0
101631-19-0
Asp. Tox. 1
kresoxim-methyl (ISO); methyl (E)-2-methoxyimino-[2-(o-tolyloxymethyl)phenyl]acetate
604-351-6
143390-89-0
Carc. 2
lead acetate, basic
215-630-3
1335-32-6
Carc. 2; Repr. 1A; STOT RE 2
Lead bis(tetrafluoroborate)
237-486-0
13814-96-5
yes
lead chromate molybdate sulfate red; C.I. Pigment Red 104 [This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.]
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
Lead diazide; Lead azide;lead diazide; lead azide;lead diazide; lead azide [≥ 20 % phlegmatiser]
236-542-1
13424-46-9
yes
Lead diazide; Lead azide;lead diazide; lead azide;lead diazide; lead azide [≥ 20 % phlegmatiser]
236-542-1
13424-46-9
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
Lead diazide; Lead azide;lead diazide; lead azide;lead diazide; lead azide [≥ 20 % phlegmatiser]
236-542-1
13424-46-9
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
Lead dinitrate
233-245-9
10099-74-8
yes
Lead monoxide;lead oxide
215-267-0
1317-36-8
yes
Lead oxide sulfate
234-853-7
12036-76-9
yes
Lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate (≥ 20 % phlegmatiser)
239-290-0
15245-44-0
yes
Lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate (≥ 20 % phlegmatiser)
239-290-0
15245-44-0
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
Lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate;lead 2,4,6-trinitro-m-phenylene dioxide; lead 2,4,6-trinitroresorcinoxide; lead styphnate (≥ 20 % phlegmatiser)
239-290-0
15245-44-0
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
lead sulfochromate yellow; C.I. Pigment Yellow 34 [This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.]
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
Lead titanium trioxide
235-038-9
12060-00-3
yes
Lead titanium zirconium oxide
235-727-4
12626-81-2
yes
lead(II) methanesulphonate
BLEIMETHANSULFONAT; LEAD (II) METHANESULFONATE; LEAD METHANE SULPHONATE; LEAD SALT FP
401-750-5
17570-76-2
Repr. 1A; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
yes
leucomalachite green; N, N,N',N'-tetramethyl-4,4'-benzylidenedianiline
204-961-9
129-73-7
Carc. 2; Muta. 2
licareol; (R)-3,7-dimethyl-1,6-octadien-3-ol; l-linalool
204-811-2
126-91-0
Skin Sens. 1B
lithium 1-amino-4-(4-tert-butylanilino)anthraquinone-2-sulfonate
BLUE 14 52 200
411-140-0
125328-86-1
Eye Dam. 1; Skin Sens. 1
lithium 3-oxo-1,2(2H)-benzisothiazol-2-ide
LI-BIT
411-690-1
111337-53-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
lithium nickel dioxide
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
lithium sodium (4-((5-chloro-2-hydroxyphenyl)azo)-2,4-dihydro-5-methyl-3H-pyrazol-3-onato(2-))(3-((4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl)azo)-4-hydroxy-5-nitrobenzenesulfonato(3-)) chromate(2-)
ACID RED FC 70013
414-250-7
149564-66-9
Acute Tox. 4; Eye Dam. 1
lithium sodium 4,4', 4''-(nitrilotris(ethane-2,1-diylimino(6-chloro-1,3,5-triazine-4,2-diyl)imino))tris(5-hydroxy-6-(1-sulfonaphthalene-2-ylazo)-2,7-naphthalene)disulfonate
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulphonatophenylazo)-5-hydroxy-3-(4-(2-(sulphonatooxy)ethylsulphonyl)phenylazo)naphthalene-2,7-disulphonate
REACTIVE BLUE FC 05 717
401-560-2
108624-00-6
Skin Sens. 1
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