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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 April 2024. Database contains 4821 unique substances/entries.
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Showing 1,051 - 1,100 of 4,821 results.
Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
4-methoxy-4-methylpentan-2-one
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
4-methyl-3-oxo-N-phenyl-2-(phenylmethylene)pentanamide
425-860-8
125971-57-5
Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.1 3,7]decan-2-ol
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.13,7]dec-2-yl acetate
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
4-methyl-N-(methylsulfonyl)benzenesulfonamide
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
4-methylpent-3-en-2-one; mesityl oxide
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
4-methylpentan-2-ol; methyl isobutyl carbinol
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
4-methylpentan-2-one; isobutyl methyl ketone
203-550-1
108-10-1
Flam. Liq. 2; Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
4-methylpyridine; 4-picoline
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
4-nitrophenol; p-nitrophenol
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
4-nitrosophenol
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
4-Nonylphenol, branched, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
4-nonylphenol, reaction products with formaldehyde and dodecane-1-thiol
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
4-oxo-4-(p-tolyl)butyric acid adduct with 4-ethylmorpholine
419-240-6
171054-89-0
Eye Dam. 1
4-vinylcyclohexene
202-848-9
100-40-3
Carc. 2
4H-3,1-benzoxazine-2,4(1H)-dione
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
5,5-dimethyl-3-oxocyclohex-1-enyl dimethylcarbamate 5,5-dimethyldihydroresorcinol dimethylcarbamate; dimetan
204-525-8
122-15-6
Acute Tox. 3
5,6,12,13-tetrachloroanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
5,6-dihydroxy-2,3-dihydro-1H-indolium bromide
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
5-(2-amino-5-cyano-6-[2-(2-hydroxyethoxy)ethylamino]-4-methylpyridin-3-ylazo)-3-methyl-2,4-dicarbonitrilethiophene
410-530-8
107815-88-3
Skin Sens. 1
5-(2-bromophenyl)-2-tert-butyl-2H-tetrazole
WAY-128170
420-820-6
153042-18-3
Flam. Liq. 3; Acute Tox. 4
5-(4-[4-[4-(3,5-dicarboxy-phenyl-azo)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]phenylazo)isophthalic acid, mixed monosodium and diammonium salt
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
5-[[4-chloro-6-[[2-[[4-fluoro-6-[[5-hydroxy-6-[(4-methoxy-2-sulfophenyl)azo]-7-sulfo-2-naphthalenyl]amino]-1,3,5-triazin-2-yl]amino]-1-methylethyl]amino]-1,3,5-triazin-2-yl]amino]-3-[[4-(ethenylsulfonyl)phenyl]azo]-4-hydroxy-naphtalene-2,7-disulfonic acid, sodium salt
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
5-acetoxy-2-(R, S)butyryloxymethyl-1,3-oxathiolane
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
5-acetyl-3-amino-10,11-dihydro-5H-dibenz[b, f]azepine-hydrochloride
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
5-chloro-1,3-dihydro-2H-indol-2-one
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
5-methylhexan-2-one; isoamyl methyl ketone
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
5-tert-butyl-3-isoxazolylamine hydrochloride
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; 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'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC]
204-327-1
119-47-1
Repr. 1B
yes
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-(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-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
7-[((4,6-dichloro-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-(4-((2-sulfoxy)ethyl)sulfonyl)phenylazo]naphthalene-2-sulfonic acid
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
7-amino-3-((5-carboxymethyl-4- methyl-1,3-thiazol-2- ylthio)methyl)-8-oxo-5-thia-1- azabicyclo(4.2.0)oct-2-ene-2- carboxylic acid
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
7-amino-4-hydroxy-2-naphthalenesulfonic acid, coupled with 5 (or 8) -amino-8 (or 5)-[[4-[[4-[[4-amino-6(or 7)-sulfo-1-naphthyl]azo]phenyl]amino]-3-sulfophenyl]azo]-2-naphthalenesulfonic acid and 4-hydroxy-7-(phenylamino)-2-naphthalenesulfonic acid, sodium salt
424-850-0
189702-72-5
Eye Dam. 1
7-methoxy-6-(3-morpholin-4-yl-propoxy)-3H-quinazolin-4-one [containing ≥ 0,5 % formamide (EC No 200-842-0)]
429-400-7
199327-61-2
Repr. 1B
7-oxa-3-oxiranylbicyclo [4.1.0]heptane; 1,2-epoxy- 4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
8,9,10-trinorborn-2-yl acrylate
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
8,9-dinorborn-5-ene-2,3-dicarboxylic anhydride
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
8-azaspiro[4.5]decane-7,9-dione
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
9-vinylcarbazole
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
[(4S, 5S)-4-benzyl-2-oxo-5-oxazolidinyl]methyl 4-nitrobenzenesulfonate
416-360-0
162221-28-5
Skin Sens. 1
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