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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
p-toluenesulphonic acid (containing a maximum of 5 % H2SO4);p-toluenesulphonic acid, (containing more than 5 % H2SO4)
203-180-0
104-15-4
Skin Corr. 1B
p-toluidine; 4-aminotoluene
203-403-1
106-49-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
p-tolyl 4-chlorobenzoate
UP 565
411-530-0
15024-10-9
Skin Sens. 1
p-xylene
203-396-5
106-42-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
paraquat dichloride;1,1-dimethyl-4,4'-bipyridinium dichloride
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
pebulate (ISO); N-butyl-N-ethyl-S-propylthiocarbamate
214-215-4
1114-71-2
Acute Tox. 4
pentaerythritol, dipentaerythritol, fatty acids, C6-10, mixed esters with adipic acid, heptanoic acid and isostearic acid
426-590-3
187412-41-5
Skin Sens. 1
Pentalead tetraoxide sulphate
235-067-7
12065-90-6
yes
pentane
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
pentane-2,4-dione; acetylacetone
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
pentasodium 4-amino-6-(5-(4-(2-ethyl-phenylamino)-6-(2-sulfatoethanesulfonyl)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
pentasodium 7-(4-(4-(3-(2-sulfatoethanesulfonyl)phenylamino)-6-(4-(2-sulfatoethanesulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
436-920-8
172399-10-9
Eye Dam. 1
pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
penthachloronaphthalene
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Perboric acid (H3BO2(O2)), monosodium salt, trihydrate;perboric acid (H3BO2(O2)), monosodium salt trihydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
603-902-8
13517-20-9
yes
Perboric acid (H3BO2(O2)), monosodium salt, trihydrate;perboric acid (H3BO2(O2)), monosodium salt trihydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
Perboric acid (H3BO2(O2)), monosodium salt, trihydrate;perboric acid (H3BO2(O2)), monosodium salt trihydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (H3BO2(O2)), monosodium salt, trihydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Perboric acid (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-611-8
10486-00-7
yes
Perboric acid (HBO(O2)), sodium salt, hydrate (1:1:4);perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid (HBO(O2)), sodium salt, monohydrate;perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-419-4
10332-33-9
yes
Perboric acid (HBO(O2)), sodium salt, monohydrate;perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid (HBO(O2)), sodium salt, monohydrate;perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid (HBO(O2)), sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
perfluorooctane sulfonic acid; heptadecafluorooctane-1-sulfonic acid
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
pethoxamide (ISO); 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1enyl)acetamide
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
Petrolatum (petroleum), clay-treated; Petrolatum [A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.]
A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.
309-706-6
100684-33-1
Carc. 1B
Phenanthrene, distn. residues; Heavy Anthracene Oi Redistillate [Residue from the distillation of crude phenanthrene boiling in the approximate range of 340 °C to 420 °C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.]
Residue from the distillation of crude phenanthrene boiling in the approximate range of 340°C to 420°C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.
310-169-5
122070-78-4
Carc. 1B
phenol, 2-dodecyl-, branched
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol, 3-dodecyl-, branched
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
Phenol, alkyl branched (species comprising decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, substituents);Tetrapropenyl phenol;phenol, dodecyl-, branched
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
Phenol, alkyl branched (species comprising decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, substituents);Tetrapropenyl phenol;phenol, dodecyl-, branched
310-154-3
121158-58-5
yes
Phenol, alkyl branched (species comprising decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, substituents);Tetrapropenyl phenol;phenol, dodecyl-, branched
310-154-3
121158-58-5
yes
phenol; carbolic acid; monohydroxybenzene; phenylalcohol
203-632-7
108-95-2
Muta. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1B
phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
phenyl glycidyl ether; 2,3-epoxypropyl phenyl ether;1,2-epoxy-3-phenoxypropane
204-557-2
122-60-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
phenylhydrazine
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
phenylmercury hydroxide
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
phosphamidon (ISO); 2-chloro-2-diethylcarbamoyl-1-methylvinyl dimethyl phosphate
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
phosphonic acid
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
phosphoric acid, calcium nickel salt
-
17169-61-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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