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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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-isopropyl-3-methylpyrazol-5-yl dimethylcarbamate; isolan
204-318-2
119-38-0
Acute Tox. 1; Acute Tox. 2
1-isopropyl-4-methylbenzene; p-cymene
202-796-7
99-87-6
Flam. Liq. 3; Acute Tox. 3; Asp. Tox. 1
1-methoxy-2-propanol; monopropylene glycol methyl ether
203-539-1
107-98-2
Flam. Liq. 3; STOT SE 3
1-methoxy-2-propylamine
METHOXYISOPROPYLAMINE
422-550-4
37143-54-7
Flam. Liq. 2; Skin Corr. 1B; Acute Tox. 4
1-methyl-3-nitro-1-nitrosoguanidine
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
1-methyl-3-phenyl-1-piperazine
431-180-2
5271-27-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
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
1-methylbutyl acetate
210-946-8
626-38-0
Flam. Liq. 3
1-methylimidazole
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
1-methyltrimethylene diacrylate; 1,3-butylene glycol diacrylate
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
1-naphthylamine
205-138-7
134-32-7
Acute Tox. 4
1-naphtol
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
1-nitropropane
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
1-octylazepin-2-one
N-N-OCTYLCAPROLACTAM; N-OCTYLCAPROLACTAME
420-040-6
59227-88-2
Skin Corr. 1B; Skin Sens. 1
1-pentanol
200-752-1
71-41-0
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
1-phenyl-3-(p-toluenesulfonyl)urea
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
1-phenyl-3-pyrazolidone
202-155-1
92-43-3
Acute Tox. 4
1-phenylethylamine;DL-α-methylbenzylamine
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
1-phenylethylamine;DL-α-methylbenzylamine
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
1-tert-butoxypropan-2-ol
ARCOSOLV PTB; ARCOSOLV(R) PTB
406-180-0
57018-52-7
Flam. Liq. 3; Eye Dam. 1
1-vinyl-2-pyrrolidone
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
1-vinylimidazole
214-012-0
1072-63-5
Repr. 1B
yes
11-amino-3-chloro-6,11-dihydro-5,5-dioxo-6-methyl-dibenzo[c, f][1,2]thiazepine hydrochloride
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine
432-840-2
220926-97-6
Acute Tox. 4
18-methylnonadecyl 2,2-dimethylpropanoate
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
2'-(2-cyano-4,6-dinitrophenylazo)-5'-(N, N-dipropylamino)propionanilide
BLEU DISPERSE 370; BLEU DISPERSO 370; BLEU LIP 6994; C.I. DISPERSE BLUE 370; DISPERS BLAU 370; DISPERSE BLUE 370
403-010-7
106359-94-8
Skin Sens. 1
2'-(4-chloro-3-cyano-5-formyl-2-thienyl)azo-5'-diethylaminoacetanilide
BLEU 1047679; BLUE 1047679
405-200-5
104366-25-8
Skin Sens. 1
2'-(4-chloro-3-cyano-5-formyl-2-thienylazo)-5'-diethylamino-2-methoxyacetanilide
BLEU 1044098; BLUE 1044098
405-190-2
122371-93-1
Skin Sens. 1
2(or 3)-methylbutyl acetate
282-263-3
84145-37-9
Flam. Liq. 3
2,2' -oxybisethanol; diethylene glycol
203-872-2
111-46-6
Acute Tox. 4
2,2',2''-(hexahydro-1,3,5- triazine-1,3,5-triyl)triethanol;1,3,5-tris(2-hydroxyethyl)hexahydro-1,3,5-triazine
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1
2,2'-((3,3', 5,5'-tetramethyl-(1,1'-biphenyl)-4,4'-diyl)-bis(oxymethylene))-bis-oxirane
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
2,2'-(ethylenedioxy)diethyl diacrylate; triethylene glycol diacrylate
216-853-9
1680-21-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2'-(methylimino)diethanol; N-methyldiethanolamine
203-312-7
105-59-9
Eye Irrit. 2
2,2'-(nitrosoimino)bisethanol
214-237-4
1116-54-7
Carc. 1B
2,2'-azobis[2-methylpropionamidine] dihydrochloride
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1
2,2'-azobis[N-(2-hydroxyethyl)2-methylpropionamide]
2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
2,2'-bioxirane; 1,2:3,4-diepoxybutane
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
2,2'-diallyl-4,4'-sulfonyldiphenol
TG-SA
411-570-9
41481-66-7
Skin Sens. 1
2,2'-dichloro-4,4'-methylenedianiline; 4,4'-methylene bis(2-chloroaniline)
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
2,2'-dimethyl-2,2'-azodipropiononitrile; ADZN
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
2,2'-dithio di(ethylammonium)-bis(dibenzyldithiocarbamate)
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
2,2'-iminodiethanol; diethanolamine
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2,2'-iminodiethylamine; diethylenetriamine
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,2'-methylenebis-(3,4,6-trichlorophenol); hexachlorophene
200-733-8
70-30-4
Acute Tox. 3
2,2'-methylenediphenyl diisocyanate; diphenylmethane-2,2'-diisocyanate
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
2,2'-oxydiethyl diacrylate; diethylene glycol diacrylate
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2'-thiodiethanol; thiodiglycol
203-874-3
111-48-8
Eye Irrit. 2
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