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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
4-Heptylphenol
217-862-0
1987-50-4
yes
4-Heptylphenol, branched and linear
-
-
yes
4-hexadecyl-1-phenylpyrazolidin-3-one
430-840-7
202483-63-4
Skin Sens. 1
4-hydroxy-3-(3-(4'-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin; brodifacoum
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
4-hydroxy-4-methylpentan-2-one; diacetone alcohol
204-626-7
123-42-2
Eye Irrit. 2
4-hydroxy-7-(2-aminoethyl)-1,3-benzothiazol-2(3H)-one hydrochloride
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
4-isocyanatosulphonyltoluene; tosyl isocyanate
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
4-Isododecylphenol;Phenol, 4-isododecyl
608-055-8
27147-75-7;27459-10-5
yes
4-Isododecylphenol;Phenol, 4-isododecyl
608-055-8
27147-75-7;27459-10-5
yes
4-mesyl-2-nitrotoluene
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
4-methoxy-4-methylpentan-2-one
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
4-methoxy-N,6-dimethyl-1,3,5- triazin-2-ylamine
2-METHOXY-4-METHYL-6-METHYLAMINO-1,3,5-TRIAZIN; DPX-L5296; L5296
401-360-5
5248-39-5
Acute Tox. 4; STOT RE 2
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-m-phenylene diisocyanate; toluene-2,6-di-isocyanate
209-544-5
584-84-9
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
yes
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye 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-methylheptane
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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-nitrobiphenyl
202-204-7
92-93-3
Carc. 1B
4-nitrophenol; p-nitrophenol
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
4-nitrosoaniline
211-535-6
659-49-4
Acute Tox. 4
4-nitrosophenol
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
4-nitrotoluene
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
4-nonylphenol, branched
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
4-Nonylphenol, branched and linear
-
-
yes
4-Nonylphenol, branched and linear, ethoxylated
-
-
yes
4-Nonylphenol, branched, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
4-Nonylphenol, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
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-o-tolylazo-o-toluidine; 4-amino-2',3-dimethylazobenzene; fast garnet GBC base; AAT; o-aminoazotoluene
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
4-oxo-4-(p-tolyl)butyric acid adduct with 4-ethylmorpholine
419-240-6
171054-89-0
Eye Dam. 1
4-phenylbut-1-ene
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
4-propylcyclohexanone
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
4-tert-butylbenzoic acid
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
4-tert-butylphenol
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
4-tert-Octylphenol monoethoxylate
621-345-9
2315-67-5
yes
4-vinylcyclohexene
202-848-9
100-40-3
Carc. 2
4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)-one; flupyradifurone
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
4H-3,1-benzoxazine-2,4(1H)-dione
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
5(or 6)-tert-butyl-2'-chloro-6'-ethylamino-3',7'-dimethylspiro(isobenzofuran-1(1H),9'-xanthene)-3-one
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
5,5-dimethyl-3-oxocyclohex-1-enyl dimethylcarbamate 5,5-dimethyldihydroresorcinol dimethylcarbamate; dimetan
204-525-8
122-15-6
Acute Tox. 3
5,5-dimethyl-perhydro-pyrimidin-2-one α-(4-trifluoromethylstyryl)-α-(4-trifluoromethyl)cinnamylidenehydrazone
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
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-dihydro-3H-imidazo[2,1-c]-1,2,4-dithiazole-3-thione; etem
251-684-4
33813-20-6
Acute Tox. 4
5,6-dihydroxy-2,3-dihydro-1H-indolium bromide
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
5,6-dihydroxyindole
IMEXINE OAY
412-130-9
3131-52-0
Acute Tox. 4; Eye Dam. 1
5-(2,4-dioxo-1,2,3,4-tetrahydropyrimidine)-3-fluoro-2-hydroxymethyltetrahydrofuran
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
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-(3,6,9-trioxa-2-undecy loxy)benzo(d)-1,3-dioxolane; sesamex
-
51-14-9
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-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
5-amino-6-methyl-1,3-dihydrobenzoimidazol-2-one
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
5-bromo-8-naphtholactam
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; 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-chloro-2,3-difluoropyridine
CDFP
410-090-7
89402-43-7
Flam. Liq. 3; Acute Tox. 4
5-chloro-2-(4-chlorophenoxy)phenol
429-290-0
3380-30-1
Eye Dam. 1
5-endo-hexyl-bicyclo[2.2.1]hept-2-ene
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
5-ethoxy-5H-furan-2-one
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one
414-470-3
95885-13-5
Acute Tox. 4
5-fluoro-1,3-dimethyl-N-[2-(4-methylpentan-2-yl)phenyl]-1H-pyrazole-4-carboxamide; 2'-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen
619-823-7
494793-67-8
Carc. 2
5-methylheptan-3-one
208-793-7
541-85-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
5-methylhexan-2-one; isoamyl methyl ketone
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
5-methylpyrazine-2-carboxylic acid
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
5-nitro-o-toluidine
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
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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