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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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-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-{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
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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