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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 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
Pitch, coal tar, low-temp; Pitch Residue [A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40 °C to 180 °C (104°F to 356 °F). Composed primarily of a complex mixture of hydrocarbons.]
A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40°C to 180°C (104°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-651-4
90669-57-1
Carc. 1B
Pitch, coal tar, low-temp., oxidized; Pitch Residue, oxidised [The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70 °C to 180 °C (158 °F to 356 °F). Composed primarily of a complex mixture of hydrocarbons.]
The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C (158°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-654-0
90669-59-3
Carc. 1B
Pitch, coal tar, low-temp., heat-treated; Pitch Residue, oxidised; Pitch Residue, heat-treated [A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50 °C to 140 °C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.]
A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.
292-653-5
90669-58-2
Carc. 1B
Pitch, coal tar, high-temp.; Pitch [The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.]
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
Pitch, coal tar, high-temp., secondary; Pitch Redistillate [The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140 °C to 170 °C (284 °F to 392 °F) according to DIN 52025. Composed primarily of tri-and polynuclear aromatic compounds which also contain heteroatoms.]
The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140° to 170°C (284°F to 392°F) according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.
302-650-3
94114-13-3
Carc. 1B
Pitch, coal tar, high-temp., heat-treated; Pitch [The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to180 °C (176 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.]
The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to 180°C (176°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
310-162-7
121575-60-8
Carc. 1B
pirimiphos-methyl (ISO); O-(2-diethylamino-6-methylpyrimidin-4-yl) O, O-dimethyl phosphorothioate
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
pirimiphos-ethyl (ISO); O, O-diethyl O-2-diethylamino-6-methylpyrimidin-4-yl phosphorothioate
245-704-0
23505-41-1
Acute Tox. 3; Acute Tox. 4
pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate
245-430-1
23103-98-2
Carc. 2; Acute Tox. 3; Skin Sens. 1
piperophos (ISO); S-2-methylpiperidinocarbonylmethyl-O, O-dipropyl phosphorodithioate
607-329-4
24151-93-7
Acute Tox. 4
piperidine
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
piperazine phosphate
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperazine hydrochloride
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperazine dihydrochloride
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperazine [liquid];piperazine [solid]
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
piperazine [liquid];piperazine [solid]
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
pindone (ISO); 2-pivaloylindan-1,3-dione
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
pilocarpine
202-128-4
92-13-7
Acute Tox. 2
physostigmine
200-332-8
57-47-6
Acute Tox. 2
phthalic anhydride
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
phoxim (ISO); α-(diethoxyphosphinothioylimino) phenylacetonitrile
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
phosphoryl trichloride
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
phosphorus trichloride
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
phosphorus tribromide
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
phosphorus pentoxide
215-236-1
1314-56-3
Skin Corr. 1A
phosphorus pentachloride
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
phosphorous acid
233-663-1
10294-56-1
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
phosphoric acid ... %, orthophosphoric acid ... %
231-633-2
7664-38-2
Skin Corr. 1B
phosphonic acid
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
phosphine
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 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
phosnichlor (ISO); O-4-chloro-3-nitrophenyl O, O-dimethyl phosphorothioate
-
5826-76-6
Acute Tox. 4
phosmet (ISO); S-[(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)methyl] O,O-dimethyl phosphorodithioate; O, O-dimethyl phthalimidomethyl S-phosphorodithioate
211-987-4
732-11-6
Repr. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 1
phosgene; carbonyl chloride
200-870-3
75-44-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
phosfolan (ISO); diethyl 1,3-dithiolan-2-ylidenephosphoramidate
213-423-2
947-02-4
Acute Tox. 1; Acute Tox. 2
phosalone (ISO); S-(6-chloro-2-oxobenzoxazolin-3-ylmethyl) O, O-diethyl phosphorodithioate
218-996-2
2310-17-0
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
phosacetim (ISO); O,O-bis(4-chlorophenyl) N-acetimidoylphosphoramidothioate
223-874-7
4104-14-7
Acute Tox. 1; Acute Tox. 2
phorate (ISO); O,O-diethyl ethylthiomethyl phosphorodithioate
206-052-2
298-02-2
Acute Tox. 1; Acute Tox. 2
phenylmercury nitrate
200-242-9
55-68-5
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
phenylmercury hydroxide
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
phenylmercury acetate
200-532-5
62-38-4
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
phenylhydrazinium sulphate; (2:1)
257-622-2
52033-74-6
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
phenylhydrazinium chloride
200-444-7
59-88-1
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
phenylhydrazine hydrochloride
248-259-0
27140-08-5
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; 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
phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate
DPX-E6758
406-600-2
89392-03-0
Skin Sens. 1
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
phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
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