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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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-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-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-naphthol
205-182-7
135-19-3
Acute Tox. 4
2-naphthylamine
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
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-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-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
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-(nonylphenoxy)-3,6,9,12,15,18,21,24-octaoxahexacosan-1-ol
247-816-5
26571-11-9
yes
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-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
3,4,5,6-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-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
3,4-dinitrotoluene
210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
3,4-xylenol
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B
3,5,5-trimethylcyclohex-2-enone; isophorone
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
3,5-dichloro-2,6-difluoropyrdine-4-amine
220-630-1
2840-00-8
Acute Tox. 4
3,5-dinitrotoluene
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
3,5-xylenol; 3,5-dimethylphenol
203-606-5
108-68-9
Acute Tox. 3; Skin Corr. 1B
3,6,9,12-tetra-azatetradecamethylenediamine; pentacthylenehexamine
223-775-9
4067-16-7
Skin Corr. 1B; Skin Sens. 1
3,6,9-triazaundecamethylenediamine; tetraethylenepentamine
203-986-2
112-57-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3,6-diazaoctanethylenediamin; triethylenetetramine
203-950-6
112-24-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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