EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.
Last updated 26 April 2024. Database contains 4821 unique substances/entries.
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Unst. Expl.; Acute Tox. 3 |
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Acute Tox. 2 |
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Iodonium, bis[4-(1,1-dimethylethyl)phenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
213740-81-9
Dibenzo[k,n][1,4,7,10,13]tetraoxathiacyclopentadecinium, 19-[4-(1,1-dimethylethyl)phenyl]-6,7,9,10,12,13-hexahydro-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
928049-42-7
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, yttrium(3+) salt (3:1)
EC / List no:
-
| CAS no:
41242-12-0
Sulfonium, [4-[(2-methyl-1-oxo-2-propen-1-yl)oxy]phenyl]diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
911027-68-4
Gamma-Cyclodextrin, compd. with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid ion(1-)(1:1)
EC / List no:
-
| CAS no:
1329995-69-8
Methanaminium, N-[4-[[4-(dimethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
1310480-27-3
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, gallium salt (9CI)
EC / List no:
-
| CAS no:
341035-71-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, scandium(3+) salt (3:1)
EC / List no:
-
| CAS no:
350836-93-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt (1:1)
EC / List no:
-
| CAS no:
55120-77-9
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, sodium salt
EC / List no:
-
| CAS no:
82382-12-5
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with N,N-diethylethanamine (1:1)
EC / List no:
-
| CAS no:
72033-41-1
Sulfonium, triphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
144116-10-9
Methanaminium, N-[4-[[4-(dimethylamino)phenyl][4-(phenylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
1310480-28-4
Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
1310480-24-0
Quinolinium, 1-(carboxymethyl)-4-[2-[4-[4-(2,2-diphenylethenyl)phenyl]-1,2,3,3a,4,8b-hexahydrocyclopent[b]indol-7-yl]ethenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
1462414-59-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, cesium salt (1:1)
EC / List no:
-
| CAS no:
92011-17-1
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1)
EC / List no:
274-462-9
| CAS no:
70225-16-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. With pyrrolidine (1:1)
EC / List no:
-
| CAS no:
1187817-57-7
Iodonium, diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
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| CAS no:
153443-35-7
Phosphonium, triphenyl(phenylmethyl)-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
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| CAS no:
1000597-52-3
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, zinc salt
EC / List no:
-
| CAS no:
70136-72-0
Methanaminium, N,N,N-trimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1)
EC / List no:
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| CAS no:
189274-31-5
Iodonium, bis[(1,1-dimethylethyl)phenyl]-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1) (9CI)
EC / List no:
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| CAS no:
866621-50-3
Sulfonium, (thiodi-4,1-phenylene)bis[diphenyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:2)
EC / List no:
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| CAS no:
421555-73-9
Beta-Cyclodextrin, compd. with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid ion(1-)(1:1)
EC / List no:
-
| CAS no:
1329995-45-0
Iodonium, bis[4-(1,1-dimethylpropyl)phenyl]-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic
EC / List no:
-
| CAS no:
421555-74-0
Sulfonium, [4-[(2-methyl-1-oxo-2-propenyl)oxy]phenyl]diphenyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1), polymer with 2-ethyltricyclo[3.3.1.13,7]dec-2-yl 2-methyl-2-propenoate, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl 2-methyl-2-propenoate and tetrahydro-2-oxo-3-furanyl 2-methyl-2-propenoate
EC / List no:
-
| CAS no:
911027-69-5
Sulfonium, (4-methylphenyl)diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
910606-39-2
Sulfonium, bis(4-methylphenyl)phenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
341548-85-4
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, neodymium(3+) salt (3:1)
EC / List no:
-
| CAS no:
41184-65-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd.with 2-methyl-2-propanamine (1:1)
EC / List no:
-
| CAS no:
202189-84-2
Sulfonium, tris[4-(1,1-dimethylethyl)phenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1)
EC / List no:
-
| CAS no:
425670-70-8
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yes |
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yes |
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Acute Tox. 4 |
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Acute Tox. 4 |
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Acute Tox. 2; Acute Tox. 1 |
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Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1 |
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Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2 |
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Acute Tox. 2 |
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Acute Tox. 2; Acute Tox. 1 |
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Acute Tox. 2; Acute Tox. 1 |
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1,2,4-triazolidine-3,5-dione, compound with hydrazine (1:1)
EC / List no:
264-246-2
| CAS no:
63467-96-9
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Carc. 1B; Acute Tox. 3; Skin Sens. 1 |
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Acute Tox. 4 |
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Acute Tox. 4 |
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Acute Tox. 3; STOT RE 2 |
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Acute Tox. 4 |
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Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1 |
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Carc. 1A; Acute Tox. 4 |
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208-520-1
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531-86-2
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Carc. 1A; Acute Tox. 4 |
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208-519-6
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531-85-1
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Carc. 1A; Acute Tox. 4 |
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252-984-8
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36341-27-2
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Carc. 1A; Acute Tox. 4 |
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244-236-4
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21136-70-9
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Carc. 1A; Acute Tox. 4 |
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Acute Tox. 2 |
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Benzenesulfonic acid, 2,2'-dithiobis(5-methyl-, compd. with benzenamine (1:2)
EC / List no:
-
| CAS no:
63468-80-4
Benzenesulfonic acid, 2(or 4)-methyl-, compd. with benzenamine (1:1)
EC / List no:
-
| CAS no:
70788-38-4
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Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1 |
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Acute Tox. 2 |
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Methanaminium, N-(4-(amino(4-(dimethylamino)phenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-methyl-, dodecyl(sulfophenoxy)benzenesulfonate (2:1)
EC / List no:
-
| CAS no:
63428-09-1
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, (2-methoxyethoxy)acetate
EC / List no:
-
| CAS no:
82941-28-4
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, mono(dodecylbenzenesulfonate)
EC / List no:
-
| CAS no:
82794-01-2
Benzenamine, 4,4'-carbonimidoylbis[N,N-dimethyl-, monohydrochloride, 2-hydroxyethanesulfonate
EC / List no:
-
| CAS no:
86157-51-9
4,4'-carbonimidoylbis(N,N-dimethylaniline) monohydrochloride
EC / List no:
219-567-2
| CAS no:
2465-27-2
4,4'-bis[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo][1,1'-biphenyl]-2,2'-disulphonic acid, compound with 4,4'-carbonimidoylbis[N,N-dimethylphenylamine] (1:2)
EC / List no:
277-106-0
| CAS no:
72939-51-6
Benzenesulfonic acid, 4-dodecyl-, compd. with 4,4'-carbonimidoylbis(N,N-dimethylbenzenamine) (1:1)
EC / List no:
-
| CAS no:
63589-43-5
Decyl hydrogen sulphate, compound with 4,4'-carbonimidoylbis[N,N-dimethylaniline] (1:1)
EC / List no:
281-828-1
| CAS no:
84030-53-5
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Carc. 2; Acute Tox. 4; Eye Irrit. 2 |
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265-294-7
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64969-36-4
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Carc. 1B; Acute Tox. 4 |
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210-322-5
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612-82-8
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Carc. 1B; Acute Tox. 4 |
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277-985-0
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74753-18-7
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Carc. 1B; Acute Tox. 4 |
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[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(2-hydroxy-3,5-dinitrobenzoate)
EC / List no:
-
| CAS no:
92415-49-1
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(2-hydroxy-3,5-dinitrobenzoate)
EC / List no:
-
| CAS no:
92415-48-0
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, bis(3,5-dinitrobenzoate)
EC / List no:
-
| CAS no:
92415-38-8
(1,1'-Biphenyl)-4,4'-diamine, 3,3'-dimethoxy-, monohydrochloride
EC / List no:
-
| CAS no:
111984-09-9
[1,1'-Biphenyl]-4,4'-diamine, 3,3'-dimethoxy-, mono(3,5-dinitrobenzoate)
EC / List no:
-
| CAS no:
92415-53-7
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Carc. 1B; Acute Tox. 4 |
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Carc. 1B; Acute Tox. 4; Skin Sens. 1 |
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209-030-0
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553-00-4
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Carc. 1A; Acute Tox. 4 |
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210-313-6
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612-52-2
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Carc. 1A; Acute Tox. 4 |
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Acute Tox. 4; Eye Dam. 1 |
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Tris(2-hydroxyethyl)ammonium (o,p-dichlorophenoxy)acetate
EC / List no:
219-911-1
| CAS no:
2569-01-9
1-[bis(2-hydroxypropyl)amino]propan-2-ol;2-(2,4-dichlorophenoxy)acetic acid
EC / List no:
639-766-1
| CAS no:
18584-79-7
Acetic acid, (2,4-dichlorophenoxy)-, compd. with 2-[2-[2-(octadecylamino)ethoxy]ethoxy]ethanol(1:1)
EC / List no:
-
| CAS no:
37937-04-5
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1 |
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yes |
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Carc. 1B; Acute Tox. 4 |
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Acute Tox. 4 |
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Acute Tox. 4 |
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Repr. 1B; Acute Tox. 2; Acute Tox. 3 |
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2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1)
EC / List no:
258-532-6
| CAS no:
53404-43-6
2-sec-butyl-4,6-dinitrophenol, compound with 1-aminopropan-2-ol (1:1)
EC / List no:
275-931-0
| CAS no:
71735-19-8
2-sec-butyl-4,6-dinitrophenol, compound with 2,2',2''-nitrilotriethanol (1:1)
EC / List no:
229-166-4
| CAS no:
6420-47-9
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Repr. 1B; Acute Tox. 3; Eye Irrit. 2 |
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Acute Tox. 3 |
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Acute Tox. 3 |
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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425-210-3
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169939-84-8
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Skin Sens. 1 |
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68583-35-7
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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200-712-3
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69-72-7
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Repr. 2; Acute Tox. 4; Eye Dam. 1 |
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202-345-4
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94-59-7
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Carc. 1B; Muta. 2; Acute Tox. 4 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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617-100-0
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8051-02-3
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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618-004-1
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87392-12-9
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Skin Sens. 1 |
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243-193-9
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19622-19-6
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Acute Tox. 4 |
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249-013-5
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28434-00-6
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Acute Tox. 4 |
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2635-50-9
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Acute Tox. 3 |
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620-370-2
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2703-37-9
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Acute Tox. 2; Acute Tox. 1 |
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X4261
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401-850-9
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255881-94-8
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yes |
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953-17-3
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Acute Tox. 3 |
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ALKYL ISOCYANATE SILANE SCD 617
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402-290-8
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85702-90-5
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Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1 |
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436-690-9
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220727-26-4
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Skin Sens. 1 |
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R-GLYCIDOL
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404-660-4
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57044-25-4
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Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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277-299-1
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73138-82-6
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Skin Sens. 1 |
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A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
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232-484-6
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8052-10-6
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Skin Sens. 1 |
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A complex combination derived from wood, especially pine wood. Composed primarily of resin acids and modified resin acids such as dimers and decarboxylated resin acids. Includes rosin stabilized by catalytic disproportionation.
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232-475-7
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8050-09-7
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Skin Sens. 1 |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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203-585-2
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108-46-3
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Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2 |
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233-940-7
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10453-86-8
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Acute Tox. 4 |
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A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and vacuum gas oil. It predominantly consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
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270-796-4
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68478-17-1
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Carc. 1B |
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A complex combination of hydrocarbons obtained by the treatment and distillation of raw steam-cracked naphtha. It consists predominantly of unsaturated hydrocarbons boiling in the range above approximately 180°C (356°F).
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308-733-0
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98219-64-8
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Carc. 1B |
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A complex residuum from the vacuum distillation of the residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C (446°F).
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270-984-6
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68512-62-9
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Carc. 1B |
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A very complex combination of hydrocarbons produced as the residual fraction from the distillation of vacuum residuum and the products from a thermal cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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272-187-9
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68783-13-1
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Carc. 1B |
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A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C24 and boiling above approximately 390°C (734°F).
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292-658-2
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90669-76-4
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Carc. 1B |
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A low-sulfur complex combination of hydrocarbons produced as the residual fraction from the topping plant distillation of crude oil. It is the residuum after the straight-run gasoline cut, kerosene cut and gas oil cut have been removed.
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271-763-7
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68607-30-7
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Carc. 1B |
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A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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265-081-9
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64741-80-6
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Carc. 1B |
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A complex combination of hydrocarbons obtained as the residual fraction from the distillation of the products of a steam cracking process (including steam cracking to produce ethylene). It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly greater than C14 and boiling above approximately 260°C (500°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
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265-193-8
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64742-90-1
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Carc. 1B |
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A complex residuum from the distillation of steam-cracked petroleum residues.
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273-272-3
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68955-36-2
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Carc. 1B |
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A complex combination of hydrocarbons obtained during the production of refined petroleum tar by the distillation of steam cracked tar. It consists predominantly of aromatic and other hydrocarbons and organic sulfur compounds.
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292-657-7
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90669-75-3
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Carc. 1B |
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A complex combination of hydrocarbons obtained as a column bottom from the separation of effluents from steam cracking naphtha at a high temperature. It boils in the range of approximately 147°C to 300°C (297°F to 572°F) and produces a finished oil having a viscosity of 18cSt at 50°C.
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295-517-3
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92062-04-9
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Carc. 1B |
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