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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 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
2,4-dinitrophenol
200-087-7
51-28-5
Acute Tox. 3; Acute Tox. 2; STOT RE 1
2,5-dimethylhexane
209-745-8
592-13-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,6-diethylaniline
209-445-7
579-66-8
Acute Tox. 4
2,6-dinitrophenol
209-357-9
573-56-8
Acute Tox. 3; STOT RE 2
2,6-xylenol
209-400-1
576-26-1
Acute Tox. 3; Skin Corr. 1B
2-(1-methylpropyl)-4-tert-butylphenol
2S4TBP
421-740-4
51390-14-8
Skin Corr. 1B
2-(3-bromophenoxy)tetrahydro-2H-pyran
CP-328,914
429-030-6
57999-49-2
Skin Sens. 1
2-(4-tert-butylphenyl)ethanol
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
2-(diphosphonomethyl)succinic acid
KEINE
403-070-4
51395-42-7
Skin Corr. 1B; Skin Sens. 1
2-(N-benzyl-N-methylamino)ethyl 3-amino-2-butenoate
EM
405-350-1
54527-73-0
Skin Sens. 1
2-[(4-chloro-2-nitrophenyl)amino]ethanol
CHLORGELB; HC YELLOW 12
413-280-8
59320-13-7
Acute Tox. 4
2-amino-4-chloro-6-methoxypyrimidine
DPX N6186; N 6186
410-050-9
5734-64-5
Acute Tox. 4
2-chloro-4-(methylsulfonyl)benzoic acid
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
2-chloropropionic acid
209-952-3
598-78-7
Acute Tox. 4; Skin Corr. 1A
2-cyclopentene-1-acetic acid, 3-hydroxy-2-pentyl-, methyl ester acetate
431-400-7
57374-49-9
Skin Sens. 1
2-ethoxy-1-methylethyl acetate; 2PG1EEA
259-370-9
54839-24-6
Flam. Liq. 3; STOT SE 3
2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
260-828-5
57583-34-3
Repr. 2
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-nitro-2-phenyl-1,3-propanediol
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
2-nitronaphthalene
209-474-5
581-89-5
Carc. 1B
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-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
3,7-dimethylocta-2,6-dienenitrile
225-918-0
5146-66-7
Muta. 1B
3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin; difenacoum
259-978-4
56073-07-5
Repr. 1B; Acute Tox. 1; STOT RE 1
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
257-187-9
51414-25-6
Skin Sens. 1A
3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione; dehydracetic acid
208-293-9
520-45-6
Acute Tox. 4
3-aminophenol
209-711-2
591-27-5
Acute Tox. 4
3-butoxypropan-2-ol; propylene glycol monobutyl ether
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
3-chloro-2-methylpropene
209-251-2
563-47-3
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate
259-627-5
55406-53-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1
3-iodpropene; allyl iodide
209-130-4
556-56-9
Flam. Liq. 2; Skin Corr. 1B
3-methyl-5-phenylpentan-1-al
433-900-0
55066-49-4
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
3-methylbutan-2-one; methyl isopropyl ketone
209-264-3
563-80-4
Flam. Liq. 2
3-methylheptane
209-660-6
589-81-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-methylhexane
209-643-3
589-34-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-pentanol
209-526-7
584-02-1
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
3-propanolide;1,3-propiolactone
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
4,4'-(4-iminocyclohexa-2,5-dienylidenemethylene)dianiline hydrochloride; C.I. Basic Red 9
209-321-2
569-61-9
Carc. 1B
4,4'-(oxy-(bismethylene))-bis-1,3-dioxolane
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol
209-218-2
561-41-1
yes
4,4'-methylenedi(cyclohexyl isocyanate); dicyclohexylmethane-4,4'-di-isocyanate
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
4-(1,4-dioxa-spiro[4.5]dec-8-yl)-cyclohexanone
423-860-2
56309-94-5
Skin Sens. 1
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