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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 03 May 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-chloro-4-fluoro-5-nitrophenyl(isobutyl)carbonate
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
2-chloro-4-nitroaniline
204-502-2
121-87-9
Acute Tox. 4
2-chloro-5-chloromethylthiazole
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
2-chloro-5-methyl-pyridine
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
2-chloro-5-sec-hexadecylhydroquinone
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-chloro-6-(ethylamino)-4-nitrophenol
ROT CO
411-440-1
131657-78-8
Acute Tox. 4; Skin Sens. 1
2-chloro-N-(4-methylphenyl)acetamide
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
2-chloroethanol; ethylene chlorohydrin
203-459-7
107-07-3
Acute Tox. 2; Acute Tox. 1
2-cyclohexylidene-2-phenylacetonitrile
423-740-1
10461-98-0
Acute Tox. 4
2-diethylaminoethanol; N,N-diethylethanolamine
202-845-2
100-37-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
2-diethylaminoethyl methacrylate
203-275-7
105-16-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-dimethylaminoethanol; N,N-dimethylethanolamine
203-542-8
108-01-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
2-ethoxyethanol; ethylene glycol monoethyl ether
203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
2-ethoxyethyl 2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate
C.I. DISPERSE RED 367
403-960-2
147014-52-6
Skin Sens. 1
2-ethoxyethyl acetate; ethylglycol acetate
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
2-ethylhexanoic acid
205-743-6
149-57-5
Repr. 2
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; [DOTE]
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
2-ethylhexyl acrylate
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
2-ethylphenylhydrazine hydrochloride
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-hexyloxyethanol; ethylene glycol monohexyl ether; n-hexylglycol
203-951-1
112-25-4
Acute Tox. 4; Skin Corr. 1B
2-hydroxy-3-[(2-hydroxyethyl)-[2-(1-oxotetradecyl)amino]ethyl]amino]-N,N,N-trimethyl-1-propanammonium chloride
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
2-hydroxyethylammonium perbromide
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
2-isobutyl-2-isopropyl-1,3-dimethoxypropane
430-800-9
129228-21-3
Skin Irrit. 2
2-isopropoxyethanol; ethylene glycol monoisopropyl ether
203-685-6
109-59-1
Acute Tox. 4; Eye Irrit. 2
2-isopropyl-2-(1-methylbutyl)-1,3-dimethoxypropane
406-970-5
129228-11-1
Skin Irrit. 2
2-isopropyl-4-(N-methyl)aminomethylthiazole
A-87463.0
414-800-6
154212-60-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-isopropyl-5-methylcyclohexyloxycarbonyloxy-2-hydroxypropane
FRESCOLAT MPC
417-420-9
156324-82-2
Eye Irrit. 2
2-methoxy-1-methylethyl acetate
203-603-9
108-65-6
Flam. Liq. 3
2-methoxyethanol; ethylene glycol monomethyl ether
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
2-methoxyethyl acetate; methylglycol acetate
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
2-methoxyethylmercury chloride
204-659-7
123-88-6
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-methoxypropanol
216-455-5
1589-47-5
Flam. Liq. 3; Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
2-methyl-1,5-pentanediamine-1,3-benzenedicarboxylate
433-910-5
145153-52-2
Skin Sens. 1
2-methyl-1-pentylpyridinium bromide
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
2-methyl-3-(trimethoxysilyl)propyl-2-propenoate hydrolysis product with silica
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
2-methyl-4-(1,1-dimethylethyl)-6-(1-methyl-pentadecyl)-phenol
CG 31-1919
410-760-9
157661-93-3
Skin Irrit. 2; Skin Sens. 1
2-methyl-4-oxo-3-(penta-2,4- dienyl)cyclopent-2-enyl [1R- [1α[S*(Z)],3β]]-chrysanthemate; pyrethrin I
204-455-8
121-21-1
Acute Tox. 4
2-methyl-4-oxo-3-(penta-2,4- dienyl)cyclopent-2-enyl[1R- [1α[S*(Z)](3β)]]-3-(3-methoxy-2-methyl-3-oxoprop-1-enyl)-2,2- dimethylcyclopropanecar boxylate; pyrethrin II
204-462-6
121-29-9
Acute Tox. 4
2-methylaminoethanol; N-methylethanolamine; N-methyl-2-ethanolamine; N-methyl-2-amino ethanol; 2-(methylamino)ethanol
203-710-0
109-83-1
Acute Tox. 4; Skin Corr. 1B
2-methylpentane-2,4-diol
203-489-0
107-41-5
Eye Irrit. 2; Skin Irrit. 2
2-methylpropene
204-066-3
115-11-7
Flam. Gas 1; Press. Gas
2-methylpyridine; 2-picoline
203-643-7
109-06-8
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
2-naphthol
205-182-7
135-19-3
Acute Tox. 4
2-naphthylamino-6-sulfomethylamide
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
2-phenoxyethanol
204-589-7
122-99-6
Acute Tox. 4; STOT SE 3; Eye Dam. 1
2-phenyl-1,3-propanediol
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1
2-phenylethylisocyanate
2-PHENYLETHYLISOCYANAT; 2-PHENYLETHYLISOCYANATE; PHENYL ETHYL ISOCYANATE
413-080-0
1943-82-4
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
2-phenylthioaniline
2-ADPS
413-030-8
1134-94-7
Skin Sens. 1
2-phthalimidoethyl N-[4-(2-cyano-4-nitrophenylazo)phenyl]-N-methyl-β-alaninate
426-400-9
170222-39-6
Skin Sens. 1
2-piperazin-1-ylethylamine
205-411-0
140-31-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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