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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 16 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
5-nitro-o-toluidine hydrochloride
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
5-nitroacenaphthene
210-025-0
602-87-9
Carc. 1B
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]
-
-
yes
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
5-tert-butyl-3-isoxazolylamine hydrochloride
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
5-thiazolylmethanol
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
5-{4-[5-amino-2-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-sulfo-phenylamino]-6-chloro-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfo-naphthalen-2-ylazo)-naphthalene-2,7-disulfonicacid sodium salt
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
6,13-dichloro-3,10-bis{2-[4-fluoro-6-(2-sulfophenylamino)-1,3,5-triazin-2-ylamino]propylamino}benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium-, sodium salt
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
6,6'-bis(diazo-5,5', 6,6'-tetrahydro-5,5'-dioxo)[methylene-bis(5-(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulphonyloxy)-6-methyl-2-phenylene]di(naphthalene-1-sulfonate)
441-550-5
-
Self-react. C; Carc. 2
6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC]
204-327-1
119-47-1
Repr. 1B
yes
6,7-dihydrodipyrido[1,2-α:2',1'- c]pyrazinediylium dihydroxide
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
6-(1α,5aβ,8aβ,9-pentahydroxy-7β-isopropyl-2β,5β,8β-trimethylperhydro-8bα,9-epoxy-5,8-ethanocyclopenta[1,2-b]indenyl) pyrrole-2-carboxylate; ryania
239-732-2
15662-33-6
Acute Tox. 4
6-(2,3-dimethylmaleimido)hexyl methacrylate
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
6-(nonylamino)-6-oxo-peroxyhexanoic acid
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
6-(phthalimido)peroxyhexanoic acid
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
6-dimethylaminohexan-1-ol
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
6-docosyloxy-1-hydroxy-4-(1-(4-hydroxy-3-methylphenanthren-1-yl)-3-oxo-2-oxaphenalen-1-yl)naphthalene-2-carboxylic acid
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
6-ethyl-5-fluoro-4(3H)-pyrimidone
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
6-fluoro-2-methyl-3-(4-methylthiobenzyl)indene
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
6-glycidyloxynapht-1-yl oxymethyloxirane
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
6-hydroxy-1-(3-isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
6-hydroxyindole
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
6-methoxy-m-toluidine; p-cresidine
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
6-methyl-2,4-bis(methylthio)phenylene-1,3-diamine
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
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