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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 01 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
sodium 3-(2-acetamido-4-(4-(2-hydroxybutoxy)phenylazo)phenylazo)benzenesulfonate
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
sodium 3-(methoxycarbonyl)-4-oxo-3,4,5,6-tetrahydro-2-pyridinolate
418-410-7
139122-78-4
Eye Irrit. 2
sodium 3-acetoacetylamino-4-methoxytolyl-6-sulfonate
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
sodium 3-nitrobenzenesulphonate
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
sodium 4-(4-chloro-6-(N-ethylanilino)-1,3,5-triazin-2-ylamino)-2-(1-(2-chlorophenyl)-5-hydroxy-3-methyl-1H-pyrazol-4-ylazo)benzenesulfonate
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
sodium 4-[4-(4-hydroxyphenylazo)phenylamino]-3-nitrobenzenesulfonate
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
sodium 4-hydroxy-3-(N'-(2-(2-hydroxyethylenesulfonyl)ethylene)ureido)-5-nitrobenzenesulfonate
425-460-3
1379676-84-2
Skin Sens. 1
sodium 4-sulfophenyl-6-((1-oxononyl)amino)hexanoate
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
sodium 5-n-butylbenzotriazole
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
sodium [29H,31H-phthalocyaninato-(2-)-N29,N30,N31,N32]-((3-(N-methyl-N-(2-hydroxyethyl)amino)propyl)amino)sulfonyl-sulfonato, copper complex
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
sodium and potassium 4-(3-aminopropylamino)-2,6-bis[3(4-methoxy-2-sulfophenylazo)4-hydroxy-2-sulfo-7-naphthylamino]-1,3,5-triazine
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
sodium bifluoride; sodium hydrogen difluoride
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
sodium dichromate
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
sodium ethanolate; sodium ethoxide
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
sodium hydroxide; caustic soda
215-185-5
1310-73-2
Skin Corr. 1A
sodium methanolate; sodium methoxide
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
Sodium perborate; perboric acid, sodium salt;sodium perborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium perborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Sodium perborate; perboric acid, sodium salt;sodium perborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium perborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
239-172-9
15120-21-5
yes
Sodium perborate; perboric acid, sodium salt;sodium perborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium perborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
sodium peroxide
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
sodium polysulphides
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
sodium salt of 4-amino-3,6-bis[[5-[[4-chloro-6-[(2-methyl-4-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]azo]-5-hydroxy-2,7-naphthalenedisulfonic acid
435-350-7
141250-43-3
Eye Dam. 1
sodium selenite
233-267-9
10102-18-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
sodiumpentachlorophenolate
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Solvent naphtha (petroleum), hydrocracked heavy arom.; Cracked kerosine [ complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235 °C to 290 °C (455 °F to 554 °F).]
A complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235°C to 290°C (455°F to 554°F).
309-881-9
101316-80-7
Asp. Tox. 1
Solvent naphtha (petroleum), hydrodesulfurized heavy arom.; Kerosine — unspecified [ complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180 °C to 240 °C (356 °F to 464 °F).]
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180°C to 240°C (356°F to 464°F).
309-882-4
101316-81-8
Asp. Tox. 1
Solvent naphtha (petroleum), hydrodesulfurized medium; Kerosine — unspecified [ complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175 °C to 220 °C (347 °F to 428 °F).]
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175°C to 220°C (347°F to 428°F).
309-884-5
101316-82-9
Asp. Tox. 1
spirodiclofen (ISO); 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
strophantin-K
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
styrene
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
succinic anhydride
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
sulphanilic acid; 4-aminobenzenesulphonic acid
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
sulphur dichloride
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
sulphur tetrachloride
-
13451-08-6
Skin Corr. 1B
Sulphuric acid, cadmium salt (1:1), unspecified hydration rate
626-360-4
15244-35-6
yes
Tar acids, brown-coal, crude; Crude Phenols [n acidified alkaline extract of brown coal tar distillate.; Composed primarily of phenol and phenol homologs.]
An acidified alkaline extract of brown coal tar distillate. Composed primarily of phenol and phenol homologs.
309-888-7
101316-86-3
Carc. 1B; Muta. 1B
Tar brown-coal [An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one-to three-ring aromatic hydrocarbons, their alkyl derivates, heteroaromatics and one-and two-ring phenols boiling in the range of approximately 150°C to 360 °C (302°F to 680°F).]
An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivatives, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150°C to 360°C (302°F to 680°F).
309-885-0
101316-83-0
Carc. 1A
Tar oils, coal, low-temp.; Tar Oil, high boiling [ distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160 °C to 340 °C (320°F to 644°F).]
A distillate from low-temperature coal tar. Composed primarily of hydrocarbons, phenolic compounds and aromatic nitrogen bases boiling in the range of approximately 160°C to 340°C (320°F to 644°F).
309-889-2
101316-87-4
Carc. 1B; Muta. 1B
Tar, brown-coal, low-temp. [A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.]
A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.
309-886-6
101316-84-1
Carc. 1A
Tar, coal, high-temp., residues; Coal Tar Solids Residue [Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.]
Solids formed during the coking of bituminous coal to produce crude bituminous coal high temperature tar. Composed primarily of coke and coal particles, highly aromatized compounds and mineral substances.
309-726-5
100684-51-3
Carc. 1B
Tar, coal, low-temp, distn. residues; Tar Oil, intermediate boiling [Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300 °C (572 °F). Composed primarily of aromatic compounds.]
Residues from fractional distillation of low temperature coal tar to remove oils that boil in a range up to approximately 300°C (572°F). Composed primarily of aromatic compounds.
309-887-1
101316-85-2
Carc. 1B
tau-fluvalinate (ISO); cyano-(3-phenoxyphenyl)methyl N-[2-chloro-4-(trifluoromethyl)phenyl]-D-valinate
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
tebuconazole (ISO); 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol
TEBUCONAZOLE RESP. HWG 1608
403-640-2
107534-96-3
Repr. 2; Acute Tox. 4
tebufenpyrad (ISO); N-(4-tertbutylbenzyl)-4-chloro-3-ethyl-1-methyl-1H-pyrazole-5-carboxamide
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
tecnazene (ISO); 1,2,4,5-tetrachloro-3-nitrobenzene
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
TEPP (ISO); tetraethyl pyrophosphate
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
tepraloxydim (ISO); (RS)-(EZ)-2-{1-[(2E)-3-chloroallyloxyimino]propyl}-3-hydroxy-5-perhydropyran-4-ylcyclohex-2-en-1-one
604-715-4
149979-41-9
Carc. 2; Repr. 2
terbufos (ISO); S-tert-butylthiomethyl O, O-diethylphosphorodithioate
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
tert-butyl (1R,5S)-3-azabicyclo[3.1.0]hex-6-ylcarbamate
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
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