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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 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
1,4,5,6,7,7-hexachlorobicyclo [2,2,1]hept-5-ene-2,3-dicarboxylicanhydride chlorendic anhydride
204-077-3
115-27-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,4,7,10-tetraazacyclododecane disulfate
AZA-KRONE-DISULFAT; SQ 84,042F
412-080-8
112193-77-8
Acute Tox. 4; STOT SE 3; Eye Dam. 1
1,4-bis[(vinyloxy)methyl]cyclohexane
RAPICURE CHVE
413-370-7
17351-75-6
Skin Sens. 1
1,4-dichloro-2-(1,1,2,3,3,3-hexafluoropropoxy)-5-nitrobenzene
CA 946 A
415-580-4
130841-23-5
Acute Tox. 4; Skin Sens. 1
1,4-dichlorobenzene; p-dichlorobenzene
203-400-5
106-46-7
Carc. 2; Eye Irrit. 2
1,4-Dicyano-2,3,5,6-tetra-chloro-benzene
TETRACHLOROTEREPHTHALONITRILE
401-550-8
1897-41-2
Skin Sens. 1
1,4-dihydroxybenzene; hydroquinone; quinol
204-617-8
123-31-9
Carc. 2; Muta. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1,4-dinitrobenzene
202-833-7
100-25-4
Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,4-dioxane
204-661-8
123-91-1
Flam. Liq. 2; Carc. 1B; Eye Irrit. 2; STOT SE 3
yes
1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene
236-948-9
13560-89-9
yes
1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate
HÄRTER VERSUCHSPRODUKT LS 2959E; HÄRTER VP LS 2959E
411-700-4
140921-24-0
Skin Sens. 1
1,7,7-Trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one; 3-Benzylidene camphor
239-139-9
15087-24-8
yes
1,7,7-trimethylbicyclo(2,2,1)hept-2-yl thiocyanatoacetate; isobornyl thiocyanoacetate
204-081-5
115-31-1
Acute Tox. 4
1-((2-quinolinyl-carbonyl)oxy)-2,5-pyrrolidinedione
PTH-SUCCINIMIDESTER
418-630-3
136465-99-1
Eye Dam. 1; Skin Sens. 1
1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethanone methanesulfonate
431-010-7
154486-26-7
Acute Tox. 4; Eye Dam. 1
1-(2-(ethyl(4-(4-(4-(4-(ethyl(2-pyridinoethyl)amino)-2-methylphenylazo)benzoylamino)-phenylazo)-3-methylphenyl)amino)ethyl)-pyridinium dichloride
ORANGE DK 2764
420-950-3
163831-67-2
Eye Dam. 1
1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
PYRAZOL P5; PYRAZOLE DHE
429-300-3
155601-30-2
Eye Dam. 1; Skin Sens. 1
1-(3-(4-fluorophenoxy)propyl)3-methoxy-4-piperidinone
T1314
411-500-7
116256-11-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1-(3-cyclopentyloxy-4-methoxyphenyl)-4-oxo-cyclohexanecarbonitrile
427-450-4
152630-47-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
1-(3-iodo-4-aminobenzyl)-1H-1,2,4-triazole
IODOANILINE TRIAZOLE
419-540-7
160194-26-3
Acute Tox. 4; Skin Sens. 1
1-(3-methoxypropyl)-4-piperidinamine
431-950-8
179474-79-4
Acute Tox. 4; Skin Corr. 1B
1-(3-phenylpropyl)-2-methylpyridinium bromide
NT-8
405-930-4
10551-42-5
Acute Tox. 4; Eye Irrit. 2
1-(mercaptomethyl)cyclopropylacetic acid
420-240-3
162515-68-6
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
1-(N,N-dimethylcarbamoyl)-3-tert-butyl-5-carbethoxymethylthio-1H-1,2,4-triazole
TRIAZAMATE
411-650-3
110895-43-7
Acute Tox. 3
1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine
SANDUVOR 3058; SANDUVOR 3058 LIQ.
411-930-5
106917-31-1
Skin Irrit. 2; Skin Sens. 1
1-allyl-3-chloro-4-fluorobenzene
CFA; HOE 108219
406-630-6
121626-73-1
Skin Irrit. 2
1-amino-1-cyanamino-2,2-dicyanoethylene, sodium salt
425-870-2
19450-38-5
Skin Sens. 1
1-amino-4-(3-[4-chloro-6-(2,5-di-sulfophenylamino)-1,3,5-triazin-2-ylamino]-2,2-dimethyl-propylamino)-anthraquinone-2-sulfonic acid, sodium/lithium salt
BLAU MUB 557
419-520-8
172890-93-6
Skin Sens. 1
1-aminocyclopentanecarboxamide
422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
1-bromo-2-methylpropyl propionate
422-900-6
158894-67-8
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Skin Sens. 1
1-bromo-3,4,5-trifluorobenzene
1-BROM-3,4,5-TRIFLUORBENZOL; 1-BROMO-3,4,5-TRIFLUOROBENZENE
418-480-9
138526-69-9
Flam. Liq. 3; Carc. 2; Skin Irrit. 2; Eye Dam. 1
1-bromo-9-(4,4,5,5,5-pentafluoropentylthio)nonane
BROMIDE 182,780
422-850-5
148757-89-5
Skin Sens. 1
1-bromopropane; n-propyl bromide
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
1-chloro-2,3-epoxypropane; epichlorhydrin
203-439-8
106-89-8
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
1-chloro-4-nitrobenzene
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
1-chlorobutane; butyl chloride
203-696-6
109-69-3
Flam. Liq. 2
1-chloromethyl-4-fluoro-1,4-diazoniabicyclo[2.2.2]octane bis(tetrafluoroborate)
414-380-4
140681-55-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1-cyclopropyl-3-(2-methylthio-4-trifluoromethylphenyl)-1,3-propanedione
421-080-7
161462-35-7
STOT RE 2
1-dimethylaminopropan-2-ol; dimepranol (INN)
203-556-4
108-16-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
1-dimethylcarbamoyl-4-(2-sulfonatoethyl)pyridinium
418-440-0
136997-71-2
Skin Sens. 1
1-ethoxy-2,3-difluorobenzene
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
1-ethoxypropan-2-ol; 2PG1EE; 1-ethoxy-2-propanol; propylene glycol monoethyl ether
216-374-5
1569-02-4
Flam. Liq. 3; STOT SE 3
1-ethyl-5,6,7,8-tetrahydroquinolinium tosylate
419-570-0
195006-58-7
Acute Tox. 4
1-hydroxy-4-fluoro-1,4-diazoniabicyclo[2.2.2]octane bis(tetrafluoroborate)
418-330-2
162241-33-0
Expl. 1.1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
1-hydroxybenzotriazole, monohydrated
602-929-2
123333-53-9
Expl. 1.3
1-imidazol-1-yl-octadecan-2-ol
434-120-3
1380001-48-8
Skin Sens. 1
1-isopropyl-3-methylpyrazol-5-yl dimethylcarbamate; isolan
204-318-2
119-38-0
Acute Tox. 1; Acute Tox. 2
1-methoxy-2-propanol; monopropylene glycol methyl ether
203-539-1
107-98-2
Flam. Liq. 3; STOT SE 3
1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-1H-pyrazole-5-sulfonamide
424-160-1
139481-22-4
Acute Tox. 4
1-methyl-4-nitro-3-propyl-1H-pyrazole-5-carboxamide
423-960-6
139756-01-7
Acute Tox. 4; STOT RE 2
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