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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 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
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; 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-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
2-methylpyridine; 2-picoline
203-643-7
109-06-8
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
2-methylstyrene; 2-vinyltoluene
210-256-7
611-15-4
Acute Tox. 4
2-n-butyl-benzo[d]isothiazol-3-one
SUBSTANCE S123386; VANQUISH 100
420-590-7
4299-07-4
Skin Corr. 1B; Skin Sens. 1
2-n-hexadecylhydroquinone
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
2-naphthol
205-182-7
135-19-3
Acute Tox. 4
2-naphthylamine
202-080-4
91-59-8
Carc. 1A; 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-nitro-2-phenyl-1,3-propanediol
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
2-nitro-p-anisidine; 4-methoxy-2-nitroaniline
202-547-2
96-96-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
2-nitroanisole
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
2-nitronaphthalene
209-474-5
581-89-5
Carc. 1B
2-nitropropane
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
2-nitrotoluene
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
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-phenylhexanenitrile
SALICYNALVA
423-460-8
3508-98-3
Acute Tox. 4
2-phenylphenol (ISO)biphenyl-2-ol; 2-hydroxybiphenyl
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2-phenylpropene; α-methylstyrene
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
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
2-tert-butylaminoethyl methacrylate
223-228-4
3775-90-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-thiazolidinylidenecyanamide
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
2-{2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethoxy}ethanol
687-833-9
1119449-38-5
yes
2-{4-(2-ammoniopropylamino)-6-[4-hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-2-aminopropyl formate
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
2-{4-[4-[4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino]phenylazophenylazo}naphthalene-4,6,8-trisulfonate, trisodium salt
442-230-8
321679-52-1
Eye Dam. 1
20-(4-nonylphenoxy)-3,6,9,12,15,18-hexaoxaicosan-1-ol
248-743-1
27942-27-4
yes
20-[4-(1,1,3,3-tetramethylbutyl)phenoxy]-3,6,9,12,15,18-hexaoxaicosan-1-ol
219-682-8
2497-59-8
yes
26-(4-nonylphenoxy)-3,6,9,12,15,18,21,24-Octaoxahexacosan-1-ol
604-395-6
14409-72-4
yes
26-(nonylphenoxy)-3,6,9,12,15,18,21,24-octaoxahexacosan-1-ol
247-816-5
26571-11-9
yes
2S-isopropyl-5R-methyl-1R-cyclohexyl 2,2-dihydroxyacetate
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
COUPLER II; UC-136
406-200-8
117827-06-2
Skin Sens. 1
3'-(3-acetyl-4-hydroxyphenyl)-1,1-diethylurea
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
3'-trifluoromethylisobutyranilide
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
3(or 5)-(4-(N-benzyl-N-ethylamino)-2-methylphenylazo)1,4-dimethyl-1,2,4-triazolium methylsulphate
BASIC RED FC 48215
406-055-0
124584-00-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt
440-770-9
371921-63-0
Eye Dam. 1
3,3'-dichlorobenzidine; 3,3'-dichlorobiphenyl-4,4'-ylenediamine
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
3,3'-dimethoxybenzidine; o-dianisidine
204-355-4
119-90-4
Carc. 1B; Acute Tox. 4
3,3'-iminodi(propylamine); dipropylenetriamine
200-261-2
56-18-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
3,3,4,4-tetrafluoro-4-iodo-1-butene
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
3,3-dimethylhexane
209-243-9
563-16-6
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3,3-dimethylpentane
209-230-8
562-49-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3,4,3', 4'-tetraphenyl-1,1'-ethandiylbispyrol-2,5-dione
431-500-0
226065-73-2
Skin Sens. 1
3,4,5,6-tetrahydrophthalic anhydride
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
3,4-dichloroaniline
202-448-4
95-76-1
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
3,4-dihydroxy-5-nitrobenzaldehyde
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
3,4-dimethyl-1H-pyrazole
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
3,4-dimethylhexane
209-504-7
583-48-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3,4-dinitrophenol
209-415-3
577-71-9
Acute Tox. 3; STOT RE 2
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