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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 dubna 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
Distillates (petroleum), polymd. steam-cracked petroleum distillates, C5-12 fraction; Low boiling point naphtha- unspecified [ complex combination of hydrocarbons obtained from the distillation of polymerized steam-cracked petroleum distillate. It consists predomi nantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12.]
A complex combination of hydrocarbons obtained from the distillation of polymerized steam-cracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
270-735-1
68477-50-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), solvent dewaxed heavy paraffinic, clay-treated; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating dewaxed heavy paraffinic distillate with neutral or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50.]
A complex combination of hydrocarbons obtained by treating dewaxed heavy paraffinic distillate with neutral or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
292-616-3
90640-94-1
Carc. 1B
Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated; Baseoil — unspecified [ complex combination of hydrocarbons resulting from treatment of dewaxed light paraffinic distillate with natural or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.]
A complex combination of hydrocarbons resulting from treatment of dewaxed light paraffinic distillate with natural or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.
292-618-4
90640-96-3
Carc. 1B
Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated; Baseoil — unspecified [ complex combination of hydrocarbons produced by Treating a dewaxed light paraffinic distillate with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.]
A complex combination of hydrocarbons produced by treating a dewaxed light paraffinic distillate with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.
292-620-5
90640-97-4
Carc. 1B
Distillates (petroleum), solvent-dewaxed heavy naphthenic; Baseoil — unspecified [ complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 . through C50 and produces a finished oil of not less than 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbon obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of not less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-167-6
64742-63-8
Carc. 1B
Distillates (petroleum), solvent-dewaxed heavy paraffinic; Baseoil — unspecified [ complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity not less than 100 SUS at 100 °F (19cSt at 40 °C).]
A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity not less than 100 SUS at 100°F (19cSt at 40°C).
265-169-7
64742-65-0
Carc. 1B
Distillates (petroleum), solvent-dewaxed light naphthenic; Baseoil — unspecified [ complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly in the range C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-168-1
64742-64-9
Carc. 1B
Distillates (petroleum), solvent-dewaxed light paraffinic; Baseoil — unspecified [ complex comination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C).]
A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-159-2
64742-56-9
Carc. 1B
Distillates (petroleum), solvent-refined heavy naphthenic; Baseoil — unspecified [ complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt a 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-097-6
64741-96-4
Carc. 1B
Distillates (petroleum), solvent-refined heavy paraffinic; Baseoil — unspecified [ complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C).]
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-090-8
64741-88-4
Carc. 1B
Distillates (petroleum), solvent-refined hydrocracked light; Baseoil — unspecified [ complex combination of hydrocarbons obtained by solvent dearomatization of the residue of hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).]
A complex combination of hydrocarbons obtained by solvent dearomatization of the residue of hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).
305-589-0
94733-09-2
Carc. 1B
Distillates (petroleum), solvent-refined hydrogenated heavy; Baseoil — unspecified [ complex combination of hydrocarbons, obtained by the treatment of a hydrogenated petroleum distillate with a solvent. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C19 through C40 and boiling in the range of approximately 390 °C to 550 °C (734 °F to 1022 °F).]
A complex combination of hydrocarbons obtained by the treatment of a hydrogenated petroleum distillate with a solvent. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C19 through C40 and boiling in the range of approximately 390°C to 550°C (734°F to 1022°F).
307-011-2
97488-74-9
Carc. 1B
Distillates (petroleum), solvent-refined hydrotreated heavy; hydrogenated; Baseoil — unspecified
305-588-5
94733-08-1
Carc. 1B
Distillates (petroleum), solvent-refined light naphthenic, hydrotreated; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst and removing the aromatic hydrocarbons by solvent extraction. It consists predominantly of naphthenic hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of between 13-15cSt at 40 °C.]
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst and removing the aromatic hydrocarbons by solvent extraction. It consists predominantly of naphthenic hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of between 13-15cSt at 40°C.
295-316-0
91995-54-9
Carc. 1B
Distillates (petroleum), solvent-refined light naphthenic; Baseoil — unspecified [ complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19 cSt at 40°C). It contains relatively few normal paraffins.
265-098-1
64741-97-5
Carc. 1B
Distillates (petroleum), solvent-refined light paraffinic; Baseoil — unspecified [ complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C).]
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-091-3
64741-89-5
Carc. 1B
Distillates (petroleum), solvent-refined middle; Gasoil — unspecified [A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302°F to 653 °F).]
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302°F to 653°F).
265-093-4
64741-91-9
Carc. 1B
Distillates (petroleum), steam-cracked heavy tar light; Cracked kerosine [ complex combination of hydrocarbons obtained by distillation of steam cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100 °C to 250 °C (212 °F to 482 °F).]
A complex combination of hydrocarbons obtained by distillation of steam cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-940-9
101631-15-6
Asp. Tox. 1
Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light steam-cracked petroleum naphtha C5 fraction; Low boiling point naphtha -unspecified
270-738-8
68477-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), steam-cracked, C5-12 fraction; Low boiling point naphtha -unspecified [ complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.]
A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
270-736-7
68477-53-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), steam-cracked, C8-12 fraction, polymd., distn. lights; Low boiling point naphtha -unspecified [ complex combination of hydrocarbons obtained by distillation of the polymerized C8 through C12 fraction from steam-cracked petroleum distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C12.]
A complex combination of hydrocarbons obtained by distillation of the polymerized C8 through C12 fraction from steam-cracked petroleum distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
305-750-5
95009-23-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), steam-cracked, C8-12 fraction; Cracked kerosine [ complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C8 through C12.]
A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
270-737-2
68477-54-3
Asp. Tox. 1
Distillates (petroleum), steam-cracked; Cracked kerosine [A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C7 through C16 and boiling in the range of approximately 90 °C to 290 °C (190 °F to 554 °F).]
A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C7 through C16 and boiling in the range of approximately 90°C to 290°C (190°F to 554°F).
265-194-3
64742-91-2
Asp. Tox. 1
Distillates (petroleum), straight-run light; Low boiling point naphtha [ complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C7 and boiling in the range of approximately- 88 °C to 99°C (- 127°F to 210°F).]
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C7 and boiling in the range of approximately -88°C to 99°C (-127°F to 210°F).
270-077-5
68410-05-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), sweetened middle; Gasoil — unspecified [A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302 o F to 653°F).]
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302°F to 653°F).
265-088-7
64741-86-2
Carc. 1B
Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-contg.; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerized C5 olefins and boiling in the range of approximately 33o C to 184 o C (91°F to 363 °F).]
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerized C5 olefins and boiling in the range of approximately 33°C to 184°C (91°F to 363°F).
271-632-4
68603-01-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), thermal cracked naphtha and gas oil, extractive; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons, predomi nantly isoamylenes such as 2-methyl-1-buteneand 2-methyl-2-butene and boiling in the rangeof approximately 31o C to 40o C (88°F to 104°F).]
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons, predominantly isoamylenes such as 2-methyl-1-butene and 2-methyl-2-butene and boiling in the range of approximately 31°C to 40°C (88°F to 104°F).
271-634-5
68603-03-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), thermal cracked naphtha and gas oil; Low boiling point thermally cracked naphtha [ complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approxi mately 33 o C to 60 o C (91 °F to 140 °F).]
A complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approximately 33°C to 60°C (91°F to 140°F).
271-631-9
68603-00-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Distillates (petroleum), thermal-cracked, alkylarom. hydrocarbon-rich; Cracked kerosine [ complex combination of hydrocarbons obtained by distillation of thermal-cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100 °C to 250°C (212°F to 482°F.]
A complex combination of hydrocarbons obtained by distillation of thermal-cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-866-7
101316-61-4
Asp. Tox. 1
Distillates (petroleum), vacuum; Heavy Fuel oil [A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having numbers predominantly in the range of C15 through C50 and boiling in the range of approximately 270 °C to 600 °C (518°F to 1112 °F). This stream is likely to contain 5 wt.% or more of 4-to 6-membered condensed ring aromatic hydrocarbons.]
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and boiling in the range of approximately 270°C to 600°C (518°F to 1112°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
274-685-1
70592-78-8
Carc. 1B
Distillates (petroleum),light steam-cracked naphtha; Cracked gasoil [ complex combination of hydrocarbons from the multiple distillation of products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C10 through C18.]
A complex combination of hydrocarbons from the multiple distillation of products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C10 through C18.
270-662-5
68475-80-9
Carc. 1B
Distillates(petroleum), heavy paraffinic; Unrefined ormildly refined baseoil [A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C). It contains a relatively large proportion of saturated aliphatic hydrocarbons.]
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons.
265-052-0
64741-51-1
Carc. 1A
disul (ISO); 2-(2,4-dichlorophenoxy)ethyl hydrogensulphate; 2,4-DES
205-259-5
149-26-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
disulfiram; tetraethylthiuramdisulfide
202-607-8
97-77-8
Acute Tox. 4; STOT RE 2; Skin Sens. 1
disulfoton (ISO); O,O-diethyl 2-ethylthioethyl phosphorodithioate
206-054-3
298-04-4
Acute Tox. 1; Acute Tox. 2
disulphur dichloride; sulfur monochloride
233-036-2
10025-67-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
ditalimfos (ISO); O, O-diethyl phthalimidophosphonothioate
225-875-8
5131-24-8
Skin Irrit. 2; Skin Sens. 1
dithallium sulphate; thallic sulphate
231-201-3
7446-18-6
Acute Tox. 2; STOT RE 1; Skin Irrit. 2
dithianon (ISO); 5,10-dihydro-5,10-dioxonaphtho(2,3-b)(1,4)dithiazine-2,3- dicarbonitrile
222-098-6
3347-22-6
Acute Tox. 4
diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea
206-354-4
330-54-1
Carc. 2; Acute Tox. 4; STOT RE 2
divanadium pentaoxide; vanadium pentoxide
215-239-8
1314-62-1
Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3
divanadyl pyrophosphate
BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
407-130-0
65232-89-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
dixanthogen; O, O-diethyl dithiobis(thioformate)
207-944-4
502-55-6
Acute Tox. 4
DNOC (ISO); 4,6-dinitro-o-cresol
208-601-1
534-52-1
Muta. 2; Acute Tox. 2; Acute Tox. 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
dodecachloropentacyclo[5.2.1.02,6.03,9.05,8]decane; mirex
219-196-6
2385-85-5
Carc. 2; Repr. 2; Lact.; Acute Tox. 4
Dodecamethylcyclohexasiloxane; D6
208-762-8
540-97-6
yes
dodecyl 3,4,5-trihydroxybenzoate
214-620-6
1166-52-5
Skin Sens. 1
dodecyl 3-amino-4-chlorobenzoate
428-020-9
6195-20-6
Skin Sens. 1
dodecyl methacrylate
205-570-6
142-90-5
STOT SE 3
dodecyldiphenyl phosphate
431-760-5
27460-02-2
Skin Irrit. 2
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