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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 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
2,2,3,3-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
2,2-ethylmethylthiazolidine
METHYL ETHYL THIAZOLIDINE
404-500-3
694-64-4
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid
236-236-8
13252-13-6
yes
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionyl fluoride
218-173-8
2062-98-8
yes
2,3,3-trimethylpentane
209-207-2
560-21-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3,4,5-tetrachlorobenzoylchloride
2,3,4,5-TETRACHLORBENZOYLCHLORID
406-760-3
42221-52-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,3,4,6-tetrachlorophenol
200-402-8
58-90-2
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
2,3,4-trichlorobut-1-ene
219-397-9
2431-50-7
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,3,4-trifluoroaniline
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2,3,4-trimethylpentane
209-292-6
565-75-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (1R,3R)-2,2-dimethyl-3-[(1Z)-prop-1-en-1-yl]cyclopropanecarboxylate; epsilon-metofluthrin
-
240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; epsilon-momfluorothrin
-
1065124-65-3
Acute Tox. 4; STOT SE 2
2,3,5,6-tetrafluorobenzoic acid
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
Skin Irrit. 2; Eye Dam. 1
2,3,5,6-tetrahydro-2-methyl-2H-cyclopenta[d]-1,2-thiazol-3-one
CIN 10096132; MTI
407-630-9
82633-79-2
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
2,3,5,6-tetrahydro-2-methylphthalic anhydride
255-853-3
42498-58-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
2,3,5-trimethylhydroquinone
211-838-3
700-13-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2,3,6-TBA (ISO); 2,3,6-trichlorobenzoic acid
200-026-4
50-31-7
Acute Tox. 4
2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
2,3-dibromopropan-1-ol; 2,3-dibromo-1-propanol
202-480-9
96-13-9
Carc. 1B; Repr. 2; Acute Tox. 3; Acute Tox. 4
yes
2,3-dichloro-5-trifluoromethyl- pyridine
DCTFMP
410-340-5
69045-84-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,3-dichloropropene; 2,3-dichloropropylene
201-153-8
78-88-6
Flam. Liq. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
2,3-dihydro-2,2-dimethyl-1H-perimidine
424-060-6
6364-17-6
Acute Tox. 4; STOT RE 2; Skin Sens. 1
2,3-dimethylbutane
201-193-6
79-29-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-dimethylhexane
209-547-1
584-94-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-dimethylpentane
209-280-0
565-59-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-dinitrophenol
200-628-7
66-56-8
Acute Tox. 3; STOT RE 2
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