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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 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-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-methoxy-2-methylbutane; tert-amyl methyl ether
213-611-4
994-05-8
Flam. Liq. 2; Acute Tox. 4; STOT SE 3
2-methoxyaniline; o-anisidine
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
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-methoxyethyl acrylate
221-499-3
3121-61-7
Flam. Liq. 3; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1
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-methoxypropyl acetate
274-724-2
70657-70-4
Flam. Liq. 3; Repr. 1B; STOT SE 3
2-methyl-1,2-benzothiazol-3(2H)-one; [MBIT]
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
2-methyl-1,5-pentanediamine-1,3-benzenedicarboxylate
433-910-5
145153-52-2
Skin Sens. 1
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
2-methyl-1-pentylpyridinium bromide
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
2-methyl-2-azabicyclo[2.2.1]heptane
THANCAT AN 10
404-810-9
4524-95-2
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
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-methyl-4-phenylpentanol
PAMPLEFLEUR
402-770-7
92585-24-5
Skin Sens. 1
2-methyl-5-(1,1,3,3-tetramethylbutyl)hydroquinone
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
2-methyl-5-phenylpentanol
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
2-methyl-5-tert-butylthiophenol
444-970-7
7340-90-1
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
2-methyl-m-phenylene diisocyanate; toluene-2,4-di-isocyanate
202-039-0
91-08-7
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
2-methyl-m-phenylenediamine; 2,6-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
2-methyl-m-phenylenediamine; 2,6-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
2-methyl-p-phenylenediamine sulphate
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
2-methyl-p-phenylenediamine sulphate
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
2-methyl-p-phenylenediamine; 2,5-toluenediamine
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
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-methylaziridine; propyleneimine
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
2-methylbutan-2-ol; tert-pentanol
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
2-methylbutyl acetat
210-843-8
624-41-9
Flam. Liq. 3
2-methylbutyl formate
252-343-2
35073-27-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
2-methylbutyl propionate
219-449-0
2438-20-2
Flam. Liq. 3
2-methylcyclohexanol, mixed isomers
209-512-0
583-59-5
Acute Tox. 4
2-methylcyclohexanone
209-513-6
583-60-8
Flam. Liq. 3; Acute Tox. 4
2-methylheptane
209-747-9
592-27-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2-methylhexane
209-730-6
591-76-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2-methylimidazole
211-765-7
693-98-1
Repr. 1B
yes
2-methylisothiazol-3(2H)-one
220-239-6
2682-20-4
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
2-methylpentane-2,4-diol
203-489-0
107-41-5
Eye Irrit. 2; Skin Irrit. 2
2-methylpropan-1-ol; iso-butanol
201-148-0
78-83-1
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
2-methylpropan-2-ol; tert-butyl alcohol
200-889-7
75-65-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
2-methylpropene
204-066-3
115-11-7
Flam. Gas 1; Press. Gas
2-methylpropyl (R)-2-hydroxypropanoate
D(+)-LACTATE D'ISOBUTYLE
407-770-0
61597-96-4
Eye Irrit. 2
2-methylpropyl 2-hydroxy-2-methylbut-3-enoate
VINYLMILCHSÄURE-ISO-BUTYLESTER
406-235-9
72531-53-4
Eye Irrit. 2; Skin Irrit. 2
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