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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
dipropyl 6,7-methylenedioxy-1,2,3,4-tetrahydro-3-methylnaphthalene-1,2-dicarboxylate; propylisome
-
83-59-0
Acute Tox. 3; Acute Tox. 4
dipropyl ether
203-869-6
111-43-3
Flam. Liq. 2; STOT SE 3
dipropylamine
205-565-9
142-84-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
diquat dibromide
201-579-4
85-00-7
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
diquat dichloride
223-714-6
4032-26-2
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
disodium (3-methyl-4-(5-nitro-2-oxidophenylazo)-1-phenylpyrazololato)(1-(3-nitro-2-oxido-5-sulfonatophenylazo)-2-naphtholato)chromate(1-)
SÄUREBRAUN 8507
404-930-1
118556-91-5
Acute Tox. 4; Eye Dam. 1
disodium (E)-1,2-bis-(4-(4-methylamino-6-(4-methylcarbamoylphenylamino)-1,3,5-triazin-2-ylamino)phenyl-2-sulfonato)ethene
427-310-2
180850-95-7
Eye Dam. 1
disodium 1-amino-4-(2-(5-chloro-6-fluoro-pyrimidin-4-ylamino-methyl)-4-methyl-6-sulfo-phenylamino)-9,10-dioxo-9,10-dihydro-anthracene-2-sulfonate
REACTIVE BLUE FC 60866
414-040-5
149530-93-8
Acute Tox. 4; Skin Sens. 1
disodium 1-amino-4-(4-benzenesulphonamido-3-sulphonatoanilino)anthraquinone-2-sulphonate
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
disodium 2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydro-pyridine-3-ylazo)-4-(4-fluoro-6-(4-(2-sulfonyloxy-ethylsulfonyl)-phenylamino)-1,3,5-triazine-2-ylamino)benzene sulfonate
432-980-4
243858-60-8
Eye Dam. 1
disodium 2-[[4-(2-chloroethylsulfonyl)phenyl]-[(2-hydroxy-5-sulfo-3-[3-[2-(2-(sulfooxy)ethylsulfonyl)ethylazo]-4-sulfobenzoato(3-)cuprate(1-)
PRODUKT 1096
414-230-8
-
Skin Sens. 1
disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate); C.I. Direct Red 28
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
disodium 3,3'-[iminobis[sulfonyl-4,1-phenylene-(5-hydroxy-3-methylpyrazole-1,4-diyl)azo-4,1-phenylenesulfonylimino-(4-amino-6-hydroxypyrimidine-2,5-diyl)azo-4,1-phenylenesulfonylimino(4-amino-6-hydroxypyrimidine-2,5-diyl)azo]bis(benzenesulfonate)]
YELLOW JB 1238
423-110-4
-
Eye Dam. 1
disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphtalene-2,7-disulphonate; C.I. Direct Black 38
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
disodium 5-[5-[4-(5-chloro-2,6-difluoropyrimidin-4-ylamino)benzamido]-2-sulfonatophenylazo]-1-ethyl-6-hydroxy-4-methyl-2-oxo-3-pyridylmethylsulfonate
YELLOW DO 2286
412-530-3
157627-98-0
Eye Dam. 1; Skin Sens. 1
disodium 6-((4-chloro-6-(N-methyl)-2-toluidino)-1,3,5-triazin-2-ylamino)-1-hydroxy-2-(4-methoxy-2-sulphonatophenylazo)naphthalene-3-sulphonate
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
disodium 7-(4,6-dichloro-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo) naphthalene-2-sulfonate
EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
404-600-7
129009-88-7
Skin Sens. 1
disodium 7-[4-chloro-6-(N-ethyl-o-toluidino)-1,3,5-triazin2-ylamino]-4-hydroxy-3-(4-methoxy-2-sulfonatophenylazo)2-naphthalenesulfonate
SCARLET X-GA 1491
410-390-8
147703-64-8
Eye Dam. 1
disodium 8-amino-5-{4-[2-(sulfonatoethoxy)sulfonyl]phenylazo}naphthalene-2-sulfonate
423-730-5
250688-43-8
Eye Dam. 1
disodium 9,10-anthracenedioxide
9,10-ANTHRACENEDIOL, DISODIUM SALT
426-030-8
46492-07-3
Skin Corr. 1A
disodium hexachloroplatinate
240-983-5
16923-58-3
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
disodium metasilicate
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
disodium N-carboxymethyl-N-(2-(2-hydroxyethoxy)ethyl)glycinate
DIDA
402-360-8
92511-22-3
Eye Dam. 1
disodium octaborate anhydrous
234-541-0
12008-41-2
Repr. 1B
yes
disodium octaborate tetrahydrate
602-894-3
12280-03-4
Repr. 1B
disodium S,S-hexane-1,6-diyldi(thiosulphate) dihydrate
DURALINK (R) HTS; ERP-390
401-320-7
5719-73-3
Skin Sens. 1
disodium sulfide; sodium sulfide
215-211-5
1313-82-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
disodium tetraborate decahydrate
603-411-9
1303-96-4
Repr. 1B
yes
Disodium tetraborate pentahydrate
601-808-1
12179-04-3
Repr. 1B
yes
disodium tetraborate, anhydrous
215-540-4
1330-43-4
Repr. 1B
yes
disodium tetrachloroplatinate
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
disodium {5-[(4'-((2,6-hydroxy3-((2-hydroxy-5-sulphophenyl)azo)phenyl)azo)(1,1'-biphenyl)-4-yl)azo]salicylato (4-)}cuprate(2-); CI Direct Brown 95
240-221-1
16071-86-6
Carc. 1B
Distillates (coal tar), benzole fraction, BTX-rich; Light Oil Redistillate, low boiling [ residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75 °C to 200 °C (167 °F to 392 °F).]
A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C (167°F to 392°F).
309-984-9
101896-26-8
Carc. 1B; Muta. 1B
Distillates (coal tar), benzole fraction, distn. residues; Wash Oil [ complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300 °C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70 °C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.]
A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300°C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70°C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.
310-165-3
121620-46-0
Carc. 1B; Muta. 1B
Distillates (coal tar), benzole fraction; Light Oil [A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160 °C (175°F to 320°F).]
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
Distillates (coal tar), heavy oils, pyrene fraction; Heavy Anthracene Oil Redistillate [The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350 °C to 400 °C (662 °F to 752 °F). Consists predominantly of tri-and polynuclear aromatics and heterocyclic hydrocarbons.]
The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C (662°F to 752°F). Consists predominantly of tri- and polynuclear aromatics and heterocyclic hydrocarbons.
295-304-5
91995-42-5
Carc. 1B
Distillates (coal tar), heavy oils; Heavy Anthracene Oil [Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752 °F). Composed primarily of tri-and polynuclear hydrocarbons and heterocyclic compounds.]
Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752°F). Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.
292-607-4
90640-86-1
Carc. 1B
Distillates (coal tar), light oils, acid exts.; Light Oil Extract Residues, high boiling [This oil is a complex reaction mass of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m- and p-cresol and boiling in the range of 140o C to 215o C (284 °F to 419 °F).]
This oil is a complex mixture of aromatic hydrocarbons, primarily indene, naphthalene, coumarone, phenol, and o-, m-, and p-cresol and boiling in the range of 140°C to 215°C (284°F to 419°F).
292-609-5
90640-87-2
Carc. 1B; Muta. 1B
Distillates (coal tar), light oils, alk. exts.; Alkaline Extract [he aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]
The aqueous extract from carbolic oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-610-0
90640-88-3
Carc. 1B; Muta. 1B
Distillates (coal tar), light oils, neutral fraction; Light Oil Extract Residues, high boiling [A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135o C to 210o C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135°C to 210°C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.
309-971-8
101794-90-5
Carc. 1B; Muta. 1B
Distillates (coal tar), light oils; Carbolic Oil [A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150 o C to 210 o C (302 °F to 410 °F).]
A complex combination of hydrocarbons obtained by distillation of coal tar. It consists of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills at the approximate range of 150°C to 210°C (302°F to 410°F).
283-483-2
84650-03-3
Carc. 1B; Muta. 1B
Distillates (coal tar), naph thalene oils, naphthalene-low; Naphthalene Oil Redistillate [ complex combination of hydrocarbons obtained by crys tallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.]
A complex combination of hydrocarbons obtained by crystallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.
284-898-1
84989-09-3
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oil crystn. mother liquor; Naphthalene Oil Redistillate [ complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200 °C to 230 °C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.]
A complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.
295-310-8
91995-49-2
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, acid exts.; Methylnaphthalene Oil Extract Residue [ complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230 °C to 255 °C (446°F to 491°F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.]
A complex combination of hydrocarbons obtained by debasing the methylnaphthalene fraction obtained by the distillation of coal tar and boiling in the range of approximately 230°C to 255°C (446°F to 491°F). Contains chiefly 1(2)-methylnaphthalene, naphthalene, dimethylnaphthalene and biphenyl.
295-309-2
91995-48-1
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, alk. exts.; Alkaline Extract [he aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.]
The aqueous extract from naphthalene oil produced by an alkaline wash such as aqueous sodium hydroxide. Composed primarily of the alkali salts of various phenolic compounds.
292-611-6
90640-89-4
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, indole-methylnaphthalene fraction; Methylnaphthalene Oil [ distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235 °C to 255 °C (455 °F to 491 °F).]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235°C to 255°C (455°F to 491°F).
309-972-3
101794-91-6
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, methylnaphthalene fraction; Methylnaphthalene Oil [ distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225 °C to 255 °C (437°F to 491 °F).]
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225°C to 255°C (437°F to 491°F).
309-985-4
101896-27-9
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils, naphthalene-free, alk. exts.; Naphthalene Oil Extract Residue [The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.]
The oil remaining after the removal of phenolic compounds (tar acids) from drained naphthalene oil by an alkali wash. Composed primarily of naphthalene and alkyl naphthalenes.
292-612-1
90640-90-7
Carc. 1B; Muta. 1B
Distillates (coal tar), naphthalene oils; Naphthalene Oil [ complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compound and aromatic nitrogen compounds and distills in the approximate range of 200 °C to 250 °C (392°F to 482°F).]-
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic and other hydrocarbons, phenolic compounds and aromatic nitrogen compounds and distills in the approximate range of 200°C to 250°C (392°F to 482°F).
283-484-8
84650-04-4
Carc. 1B; Muta. 1B
Distillates (coal tar), pitch, heavy oils; Heavy Anthracene Oil [The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri-and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300 °C to 470 °C (572 °F to 878 °F). The product may also contain heteroatoms.]
The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri- and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300°C to 470°C (572°F to 878°F). The product may also contain heteroatoms.
295-312-9
91995-51-6
Carc. 1B
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