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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one
602-927-1
123312-89-0
Carc. 2; Repr. 2
pyraclostrobin (ISO); methyl N-{2-[1-(4-chlorophenyl)-1H-pyrazol-3-yloxymethyl]phenyl}(N-methoxy)carbamate
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
pyroquilon (ISO);1,2,5,6-tetrahydropyrrolo[3,2,1- ij]quinolin-4-one
611-516-6
57369-32-1
Acute Tox. 4
pyroxsulam (ISO); N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide
610-007-6
422556-08-9
Skin Sens. 1
quinoxyfen (ISO);5,7-dichloro-4-(4-fluorophenoxy)quinoline
602-997-3
124495-18-7
Skin Sens. 1
reaction mass of (S)-Indoxacarb and (R)-Indoxacarb 75:25; methyl 7-chloro-2-{(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]carbamoyl}-2,5-dihydroindeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate [2]
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]and 2-methyl-2H-isothiazol-3-one [EC no. 220-239-6] (3:1); reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one [EC no. 247-500-7]and 2-methyl-4-isothiazolin-3-one [EC no. 220-239-6] (3:1)
611-341-5
55965-84-9
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
S-[2-(ethylsulphinyl)ethyl] O,O-dimethyl phosphorodithioate
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
S-metolachlor; reaction mass of (S)-2-chloro-N-(2-ethyl-6-methyl-phenyl)-N-(2-methoxy-1-methyl-ethyl)-acetamide (80-100 %)
618-004-1
87392-12-9
Skin Sens. 1
sabadilla (ISO);veratrine
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
sec-butyl propionate
611-802-0
591-34-4
Flam. Liq. 3
silthiofam (ISO); N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide
605-752-9
175217-20-6
STOT RE 2
silver zinc zeolite (Zeolite, LTA framework type, surface-modified with silver and zinc ions)
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
Sodium dichromate
616-541-6
7789-12-0
yes
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
spirotetramat (ISO); (5s,8s)-3- (2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4,5]dec- 3-en-4-yl ethyl carbonate
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
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
sulcotrione (ISO); 2-[2-chloro-4-(methylsulfonyl)benzoyl]cyclohexane-1,3-dione
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
Sulfuric acid, cadmium salt (1:1), hydrate (3:8)
616-572-5
7790-84-3
yes
Sulphuric acid, cadmium salt (1:1), unspecified hydration rate
626-360-4
15244-35-6
yes
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
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
tefluthrin (ISO); 2,3,5,6-tetrafluoro-4-methylbenzyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate
616-699-6
79538-32-2
Acute Tox. 1; Acute Tox. 2
tembotrione (ISO); 2-{2- chloro-4-(methylsulfonyl)-3- [(2,2,2-trifluoroethoxy)methyl] benzoyl}cyclohexane-1,3-dione
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
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
tert-butyl propionate
606-566-0
20487-40-5
Flam. Liq. 2
tetracopper hexahydroxide sulphate hydrate
682-362-5
12527-76-3
Acute Tox. 4
thiacloprid (ISO); (Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide; {(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide
601-147-9
111988-49-9
Carc. 2; Repr. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3
tralkoxydim (ISO); 2-(N-ethoxypropanimidoyl)-3-hydroxy-5-mesitylcyclohex-2-en-1-one
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
triamiphos (ISO); 5-amino-3-phenyl-1,2,4-triazol-1-yl-N, N,N',N'-tetramethylphosphonic diamide
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
trifloxystrobin (ISO); methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl) ethylideneaminooxy]-o-tolyl}acetate
604-237-6
141517-21-7
Lact.; Skin Sens. 1
triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1-(1H-imidazol-1-yl)-2-propoxyethanimine
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
triflusulfuron-methyl; methyl 2-({[4-(dimethylamino)-6- (2,2,2-trifluoroethoxy)-1,3,5- triazin-2-yl]carbamoyl}sulfamoyl)-3-methylbenzoate
603-146-9
126535-15-7
Carc. 2
trinexapac-ethyl (ISO); ethyl 4-[cyclopropyl (hydroxy) methylene]-3,5-dioxocyclohexanecarboxylate
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
tritosulfuron (ISO) (containing ≤0,02 % AMTT); 1-[4-methoxy-6-(trifluoromethyl)-1,3,5-triazin-2-yl]-3-[2-(trifluoromethyl)benzenesulfonyl]urea (containing ≤ 0,02 % AMTT)
604-291-0
142469-14-5
Skin Sens. 1
troclosene sodium, dihydrate
610-700-3
51580-86-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
white phosphorus
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
XMC; 3,5-xylyl methylcarbamate
607-955-8
2655-14-3
Acute Tox. 4
zinc sulphate (hydrous) (mono-, hexa-and hepta hydrate)
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
zoxamide (ISO); (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide
605-037-1
156052-68-5
Skin Sens. 1
α-cypermethrin (ISO); racemate comprising (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; (S)-α-cyano-3-phenoxybenzyl(1R, 3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3
α-hydroxypoly(methyl-(3-(2,2,6,6-tetramethylpiperidin-4-yloxy)propyl)siloxane)
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
701-394-3
1782069-81-1
yes
(RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy} ethyl methyl carbonate; tolpyralate
701-225-3
1101132-67-5
Carc. 2; Repr. 2; STOT RE 2
2-(4-tert-Butylbenzyl)propionaldehyde and its individual stereoisomers
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2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
799-970-2
-
yes
Alkanes, C14-16, chloro
701-376-5
1372804-76-6
yes
Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate
700-242-3
62037-80-3
yes
Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety
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Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: - | CAS no: -
799-973-9
-
yes
Medium-chain chlorinated paraffins (MCCP)
UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17
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di-, tri- and tetrachlorotetradecane EC / List no: 950-299-5 | CAS no: -
Alkanes, C14-17, chloro EC / List no: 287-477-0 | CAS no: 85535-85-9
Alkanes, C14-16, chloro EC / List no: 701-376-5 | CAS no: 1372804-76-6
Tetradecane, chloro derivs. EC / List no: - | CAS no: 198840-65-2
799-971-8
-
yes
metaflumizone (ISO); (EZ)-2-[2-(4-cyanophe-nyl)-1-(a,a,a -trifluoro-m-tolyl)ethylidene]-[4-(tri-fluoromethoxy)phenyl] carbanilohydrazide [E-iso-mer > 90 %, Z-isomer <10 % relative content]; [1] (E)-2-[2-(4-cyanophenyl)-1-(a,a,a -trifluoro-m-tolyl) ethylidene]-[4-(trifluoro-methoxy)phenyl]carbani-lohydrazide [2]
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
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