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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
2,6-dichloro-4-nitroanisole
T 1049
403-350-6
17742-69-7
Acute Tox. 3
2,6-dichloro-4-trifluoromethylaniline
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
2,6-diethylaniline
209-445-7
579-66-8
Acute Tox. 4
2,6-dimethylheptan-4-one; di-isobutyl ketone
203-620-1
108-83-8
Flam. Liq. 3; STOT SE 3
2,6-dinitrophenol
209-357-9
573-56-8
Acute Tox. 3; STOT RE 2
2,6-dinitrotoluene
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,6-xylenol
209-400-1
576-26-1
Acute Tox. 3; Skin Corr. 1B
2,6-xylidine; 2,6-dimethylaniline
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
2,7,11-trimethyl-13-(2,6,6-trimethylcyclohex-1-en-1-yl)tridecahexaen-2,4,6,8,10,12-al
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
2,7-naphthalenedisulfonic acid, nickel(II) salt
-
72319-19-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
2,9-bis(3-(diethylamino)propylsulfamoyl)quino(2,3-b)acridine-7,14-dione
PIGMENT ADDITIV AC; PIGMENTADDITIV AC
404-230-6
164578-11-4
Skin Sens. 1
2-((4-(ethyl-(2-hydroxyethyl)amino)-2-methylphenyl)azo)-6-methoxy-3-methyl-benzothiazolium methylsulfate
FAT 40'398; FAT 40'398/E
411-100-2
136213-73-5
STOT RE 2; Skin Sens. 1
2-((4-amino-2-nitrophenyl)amino)benzoic acid
RO 1082
411-260-3
117907-43-4
Eye Dam. 1; Skin Sens. 1
2-((4-methyl-2-nitrophenyl)amino)ethanol
METHYLGELB
408-090-7
100418-33-5
Acute Tox. 4; Skin Sens. 1
2-(1-methylpropyl)-4-tert-butylphenol
2S4TBP
421-740-4
51390-14-8
Skin Corr. 1B
2-(10-oxo-10H-9-oxa-10-phosphaphenanthren-10-ylmethyl)succinic acid
426-480-5
63562-33-4
Skin Sens. 1
2-(2,4-dichlorophenyl)-1-(1H—1,2,4-triazol-1-yl)pent-4-en-2-ol
TAA
407-850-5
89544-40-1
Acute Tox. 4; Eye Dam. 1
2-(2,4-dichlorophenyl)-2-(2-propenyl)oxirane
EPO
411-210-0
89544-48-9
Skin Irrit. 2; Skin Sens. 1
2-(2-(2-hydroxyethoxy)ethyl)-2-aza-bicyclo[2.2.1]heptane
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-(2-amino-1,3-thiazol-4-yl)-(Z)-2-methoxyiminoacetyl chloride hydrochloride
31 AC-HCL
410-620-7
119154-86-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-(2-aminoethylamino)ethanol; (AEEA)
203-867-5
111-41-1
Repr. 1B; Skin Corr. 1B; Skin Sens. 1
2-(2-bromoethoxy)anisole
GUAIACOL-O-ETHYLBROMIDE
402-010-4
4463-59-6
Acute Tox. 4
2-(2-butoxyethoxy)ethanol; diethylene glycol monobutyl ether
203-961-6
112-34-5
Eye Irrit. 2
2-(2-butoxyethoxy)ethyl thiocyanate
203-985-7
112-56-1
Flam. Liq. 3; Acute Tox. 3
2-(2-hexyloxyethoxy)ethanol; DEGHE; diethylene glycol monohexyl ether; 3,6-dioxa-1-dodecanol; hexyl carbitol; 3,6-dioxadodecan-1-ol
203-988-3
112-59-4
Acute Tox. 4; Eye Dam. 1
2-(2-hydroxy-3,5-dinitroanilino)ethanol
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
2-(2-iodoethyl)-1,3-propanediol diacetate
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
2-(2-methoxyethoxy)ethanol; diethylene glycol monomethyl ether
203-906-6
111-77-3
Repr. 2
2-(3,4-dichlorophenyl)-4-methyl-1,2,4-oxadiazolidinedione; methazole
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-(3,4-epoxycyclohexyl)ethyltriethoxy silane
425-050-4
10217-34-2
Skin Sens. 1
2-(3-(prop-1-en-2-yl)phenyl)prop-2-yl isocyanate
M-TMI
402-440-2
2094-99-7
Acute Tox. 2; Skin Corr. 1B; STOT RE 2; Resp. Sens. 1; Skin Sens. 1
2-(3-bromophenoxy)tetrahydro-2H-pyran
CP-328,914
429-030-6
57999-49-2
Skin Sens. 1
2-(3-chloropropyl)-2,5,5-trimethyl-1,3-dioxane
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
2-(3-iodoprop-2-yn-1-yloxy)ethyl phenylcarbamate
SIS 46 305
408-010-0
88558-41-2
Acute Tox. 4; Eye Dam. 1
2-(4-(3-(4-chlorophenyl)-2-pyra zolin-1-yl)phenylsulfonyl)ethyldimethylammonium formate
HOSTALUX VP 3481-1 HOSTALUX N2R
402-120-2
133514-97-3
Skin Corr. 1B; STOT RE 2; Skin Sens. 1
2-(4-(3-(4-chlorophenyl)-4,5- dihydropyrazolyl)phenylsulphonyl) ethyldimethylammonium hydrogen phosphonate
AZURANT PYRAZOLINE MR 5401; PYRAZOLINE BRIGHTENER MR 5401; UVITEX 4457
402-490-5
106359-93-7
Eye Irrit. 2
2-(4-(4-(butyl-(1-methylhexyl)amino)phenyl)-3-cyano-5-oxo-1,5-dihydropyrrol-2-ylidene)propandinitrile
429-180-2
157362-53-3
Skin Sens. 1
2-(4-(4-cyano-3-methylisothiazol-5-ylazo)-N-ethyl-3-methylanilino)ethyl acetate
TTP MAGENTA 3
405-480-9
110260-50-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
2-(4-(5,6(or 6,7)-dichloro-1,3-benzothiazol-2-ylazo)-N-methyl-m-toluidino)ethyl acetate
BRILLANT RED 1047729; BRILLIANT RED 1047729; ROUGE BRILLANT 1047729
405-440-0
149172-69-0
Skin Sens. 1
2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide
PIGMENT ADDITIV C
404-910-2
164578-14-7
Skin Sens. 1
2-(4-aminophenyl)-6-tert-butyl-1H-pyrazolo[1,5-b][1,2,4]triazole
FC-102B; M-3218
415-910-7
152828-25-6
Skin Sens. 1
2-(4-chloro-2-methylphenoxy)propionic acid;mecoprop (ISO); 2-(4-chloro-o-tolyloxy)propionic acid; (RS)-2-(4-chloro-o-tolyloxy)propionic acid
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-(4-chloro-2-methylphenoxy)propionic acid;mecoprop (ISO); 2-(4-chloro-o-tolyloxy)propionic acid; (RS)-2-(4-chloro-o-tolyloxy)propionic acid
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-(4-methyl-2-phenyl-1-piperazinyl)benzenemethanol monohydrochloride
420-200-5
1379676-70-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-(4-methyl-3-pentenyl)anthraquinone
428-320-1
71308-16-2
Acute Tox. 4; Skin Sens. 1
2-(4-tert-butylphenyl)ethanol
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
2-(5,5-dimethyl-2,4-dioxooxazolidin-3-yl)-4,4-dimethyl-3-oxo-N-(2-methoxy-5-octadecanoylaminophenyl)pentanoic acid amide
443-980-9
221215-20-9
Skin Sens. 1
2-(7-ethyl-1H-indol-3-yl)ethanol
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
2-(decylthio)ethylammonium chloride
XU 40304.03L ANTIMICROBIAL
405-640-8
36362-09-1
STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-(diphosphonomethyl)succinic acid
KEINE
403-070-4
51395-42-7
Skin Corr. 1B; Skin Sens. 1
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