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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 30 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
pyridaben (ISO); 2-tert-butyl-5-(4-tert-butylbenzylthio)-4-chloropyridazin-3(2H)-one
PYRIDABEN
405-700-3
96489-71-3
Acute Tox. 3
pyridate (ISO); O-(6-chloro-3-phenylpyridazin-4-yl) S-octyl thiocarbonate
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
pyridine
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
Pyridine, alkyl derivs.; Crude Tar Bases [The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approxi mately above 150o C (302oF) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.]
The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
pyrithione zinc; (T-4)-bis[1-(hydroxy-κO)pyridine-2(1H)-thionato-κS]zinc
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
Pyrochlore, antimony lead yellow
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
pyrogallol; 1,2,3-trihydroxybenzene
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
pyroquilon (ISO);1,2,5,6-tetrahydropyrrolo[3,2,1- ij]quinolin-4-one
611-516-6
57369-32-1
Acute Tox. 4
pyroxsulam (ISO); N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide
610-007-6
422556-08-9
Skin Sens. 1
quaternary ammonium compounds, benzyl-C8-18-alkyldimethyl, chlorides
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
quinalphos (ISO); O, O-diethyl-O-quinoxalin-2-yl phosphorothioate
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
quinclorac (ISO); 3,7-dichloroquinoline-8-carboxylic acid
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
quinolin-8-ol; 8-hydroxyquinoline
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
quinoline
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
quinomethionate; chinomethionat (ISO); 6-methyl-1,3-dithiolo(4,5-b)quinoxalin-2-one
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
quinoxyfen (ISO);5,7-dichloro-4-(4-fluorophenoxy)quinoline
602-997-3
124495-18-7
Skin Sens. 1
quintozene (ISO); pentachloronitrobenzene
201-435-0
82-68-8
Skin Sens. 1
quizalofop-P-tefuryl (ISO); (±) tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
R, R-2-hydroxy-5-(1-hydroxy-2-(4-phenylbut-2-ylamino)ethyl)benzamide hydrogen 2,3-bis(benzoyloxy)succinate
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
R-1-chloro-2,3-epoxypropane
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
Rabbitpox virus
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Rabies virus
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.; Low boiling point modified naphtha [ complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.]
A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.
270-088-5
68410-71-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Raffinates (petroleum), reformer, Lurgi unit-sepd.; Low boiling point modified naphtha [he complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.]
The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.
270-349-3
68425-35-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extn., C3-5 and C3-5 unsatd., butadiene-free; Petroleum gas
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
reaction mas of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2-sulfonic acid, Na/K salt
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
reaction mass (ratio not known) of: ammonium 1-C14-C18-alkyloxycarbonyl-2-(3-allyloxy-2-hydroxypropoxycarbonyl)ethane-1-sulfonate; ammonium 2-C14-C18-alkyloxycarbonyl-1-(3-allyloxy-2-hydroxypropoxycarbonyl)ethane-1-sulfonate
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
reaction mass of (S)-Indoxacarb and (R)-Indoxacarb 75:25; methyl 7-chloro-2-{(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]carbamoyl}-2,5-dihydroindeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate [2]
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
reaction mass of 1,1'-((dihydroxyphenylene)bis(azo-3,1-phenylenazo(1-(3-dimethylaminopropyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))dipyridinium dichloride dihydrochloride, mixed isomers and 1-(1-(3-dimethylaminopropyl)-5-(3-((4-(1-(3-dimethylaminopropyl)-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo)phenylazo)-2,4(or 2,6 or 3,5)-dihydroxyphenylazo)phenylazo)-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium dichloride
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
-
Skin Sens. 1
reaction mass of 1,1'-(methylenebis(4,1-phenylene))dipyrrole-2,5-dione and N-(4-(4-(2,5-dioxopyrrol-1-yl)benzyl)phenyl)acetamide and 1-(4-(4-(5- oxo-2H-2-furylide namino)benzyl)phenyl)pyrrole-2,5-dione
DESBIMID
401-970-1
-
Skin Sens. 1
reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy)but-2-ylamine
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
reaction mass of 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate and 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate and N, N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
C.I. DIRECT YELLOW 166; DIRECT YELLOW 166; GIALLO DIRETTO 166; JAUNE DIRECT 166; MONOAZO YELLOW MA 2822
403-410-1
114565-65-0
Skin Sens. 1
reaction mass of 2-acryloyloxyethyl hydrogen cyclohexane-1,2-dicarboxylate and 2-methacryloyloxyethyl hydrogen cyclohexane-1,2-dicarboxylate
KAYARAD R-825
405-360-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of 2-chloroethyl chloropropyl 2-chloroethylphosphonate, reaction mass of isomers and 2-chloroethyl chloropropyl 2-chloropropylphosphonate, reaction mass of isomers
ADINE CP 31
401-740-0
-
Acute Tox. 4
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; reaction mass of DOTE and MOTE
915-270-3
-
yes
Reaction mass of 5-(sec-butyl)-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and 5-(sec-butyl)-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane;Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
413-720-9
117933-89-8
yes
Reaction mass of 5-(sec-butyl)-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and 5-(sec-butyl)-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane;Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
413-720-9
117933-89-8
yes
reaction mass of 5-heptyl-1,2,4- triazol-3-ylamine and 5-nonyl-1,2,4-triazol-3-ylamine
PK 323
401-940-8
-
Acute Tox. 4; Eye Irrit. 2
reaction mass of 7-[4-(3-diethylaminopropylamino)-6-(3-diethylammoniopropylamino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(4-phenylazophenylazo)-naphthalene-2-sulfonate, acetic acid, lactic acid (2:1:1)
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1
reaction mass of C12-14-tert-alkylammonium diphenyl phosphorothioate and dinonyl sulphide (or disulphide)
X 3761
400-930-0
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of compounds from (dodecakis(p-tolylthio)phthalocyaninato)copper(II)to (hexadecakis(p-tolylthio)phthalocyaninato)copper(II)
PROJET 780 NP; SUBSTANCE SC101756
407-700-9
101408-30-4
Skin Sens. 1
reaction mass of disodium 6-(2,4-dihydroxyphenylazo)-3-(4-(4-(2,4-dihydroxyphenylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate and disodium 6-(2,4-diaminophenylazo)-3-(4-(4-(2,4-diaminophenylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate and trisodium 6-(2,4-dihydroxyphenylazo)-3-(4-(4-(7-(2,4-dihydroxyphenylazo)-1-hydroxy-3-sulphonato-2-naphthylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
reaction mass of dodecyl 3-(2,2,4,4-tetramethyl-21-oxo-7-oxa-3,20-diazadispiro(5,1,11,2)henicosan-20-yl)propionate and tetradecyl 3-(2,2,4,4-tetramethyl-21-oxo-7-oxa-3,20-diazadispiro(5,1,11,2)henicosan-20-yl)propionate
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
reaction mass of esters of 5,5',6,6',7,7'-hexahydroxy-3,3,3',3'-tetramethyl-1,1'-spirobiindan and 2-diazo-1,2-dihydro-1-oxo-5-sulfonaphthalene
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
reaction mass of iron complexes of: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-(5-amino-sulfonyl-2-hydroxyphenylazo)benzene; and: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-[4-(4-nitro-2-sulfophenylamino)phenylazo]benzene (n=2,5,6)
BROWN JR 543
414-150-3
-
Skin Sens. 1
reaction mass of isomers of branched tetracosane
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
reaction mass of isomers of: methyldiphenylmethane; dimethyldiphenylmethane
MARLOTHERM L
405-470-4
73807-39-3
Skin Irrit. 2
reaction mass of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
reaction mass of isomers of: sodium [(2-hydroxyethylsulfamoyl){][}2-(2-piperazin-1-ylethylamino)ethylsulfamoyl][2-(4-aminoethylpiperazine-1-yl)ethylsulfamoyl{](sulfamoyl)[}(sulfonatophthalocyaninato)]copper(II)
SUBSTANCE S166075
424-270-8
-
Eye Dam. 1
reaction mass of isomers of: sodium phenethylnaphthalenesulfonate; sodium naphthylethylbenzenesulfonate
UNISOL S
405-760-0
-
Eye Dam. 1; Skin Sens. 1
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