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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
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
2,2,3,3-tetramethylbutane
209-855-6
594-82-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2,3-trimethylbutane
207-346-3
464-06-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2,3-trimethylpentane
209-266-4
564-02-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2,4-trimethyl-4-phenyl-butane-nitrile
KHUSINIL
422-580-8
75490-39-0
Acute Tox. 4
2,2,4-trimethylhexamethylene-1,6-di-isocyanate
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
2,2,4-trimethylpentane
208-759-1
540-84-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2,6,6-tetrakis(bromomethyl)-4-oxaheptane-1,7-diol
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
2,2-(1,4-phenylene)bis((4H—3,1-benzoxazine-4-one)
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2-bis(bromomethyl)propane-1,3-diol
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
yes
2,2-bis(hydroxymethyl)butanoic acid
DMBA
424-090-1
10097-02-6
Eye Dam. 1
2,2-dialkyl-4-hydroxymethyl1,3-dioxolane; reaction products with ethylene oxide (alkyl is C1-12 and the sum to C13, average degree of ethoxylation is 3,5)
430-580-4
-
Skin Irrit. 2
2,2-dibromo- 2-cyanoacetamide; [DBNPA]
233-539-7
10222-01-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2,2-dibromo-2-nitroethanol
PERMACHEM N21
412-380-9
69094-18-4
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Skin Sens. 1
2,2-dichloro-1,3-benzodioxol
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
2,2-dichlorovinyl 2-ethylsulphinylethyl methyl phosphate
-
7076-53-1
Acute Tox. 3
2,2-diethoxy-N, N-dimethylacetamide
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
2,2-dimethyl 3-methyl-3-butenyl propanoate
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
2,2-dimethyl-1,3-benzodioxol-4-ol
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
2,2-dimethylbutane
200-906-8
75-83-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2-dimethylhexane
209-689-4
590-73-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2-dimethylpentane
209-680-5
590-35-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,2-dimethylpropan-1-ol, tribromo derivative (TBNPA)
253-057-0
36483-57-5
yes
2,2-dimethylpropane; neopentane
207-343-7
463-82-1
Flam. Gas 1; Press. Gas
2,2-dimethyltrimethylene diacrylate; neopentyl glycol diacrylate
218-741-5
2223-82-7
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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