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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
cyprodinil (ISO); 4-cyclopropyl-6-methyl-N-phenylpyrimidin-2-amine
601-785-8
121552-61-2
Skin Sens. 1
cyprofuram (ISO); N-(3-chlorophenyl)-N-(tetrahydro-2-oxo-3-furyl)cyclopropanecarboxamide
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
Cytomegalovirus
-
-
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.
D, L-(N,N-diethyl-2-hydroxy-2-phenylacetamide)
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
d-carvone; (5S)-2-methyl-5- (prop-1-en-2-yl)cyclohex-2-en- 1-one
218-827-2
2244-16-8
Skin Sens. 1
D-erythro-hexanoic acid 2,4-dideoxy-3,5-O-(1-methylethylidene)-1,1-dimethylethylester; tert-butyl 2-[(4R, 6S)-6-(hydroxymethyl)-2,2-dimethyl-1,3-dioxan-4-yl]acetate
432-960-5
124655-09-0
Acute Tox. 4
dalapon-sodium; sodium 2,2-dichloropropionate
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
dalapon; 2,2-dichloropropionic acid
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
dapsone; 4,4'-diamino diphenyl sulfone
201-248-4
80-08-0
Acute Tox. 4
dazomet (ISO);tetrahydro-3,5-dimethyl-1,3,5- thiadiazine-2-thione
208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
DDT (ISO); clofenotane (INN); dicophane;1,1,1-trichloro-2,2-bis(4-chlorophenyl)ethane; dichlorodiphenyltrichloroethane
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
Decamethylcyclopentasiloxane; D5
208-764-9
541-02-6
yes
decanoic acid
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
decarbofuran (ISO); 2,3-dihydro-2-methylbenzofuran-7-yl methylcarbamate
-
1563-67-3
Acute Tox. 3
deltamethrin (ISO); (S)-α-cyano-3-phenoxybenzyl(1R, 3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate
258-256-6
52918-63-5
Acute Tox. 3
demephion-O (ISO); O, O-dimethyl O-2-methylthioethyl phosphorothioate
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
demephion-S (ISO); O, O-dimethyl S-2-methylthioethyl phosphorothioate
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
demeton
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
demeton-O (ISO); O,O-diethyl-O-2-ethylthioethyl phosphorothioate
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
demeton-O-methyl (ISO); O-2-ethylthioethyl O,O-dimethyl phosphorothioate
212-758-1
867-27-6
Acute Tox. 3
demeton-S (ISO); diethyl-S-2-ethylthioethyl phosphorothioate
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
demeton-S-methyl (ISO); S-2-ethylthioethyl dimethyl phosphorothioate
213-052-6
919-86-8
Acute Tox. 3
demeton-S-methylsulphon(ISO); S-2-ethylsulphonylethyl dimethyl phosphorothioate
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
Dengue virus type 1-4
-
-
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.
desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate
237-198-5
13684-56-5
Repr. 2
desmetryne (ISO);6-isopropylamino-2-methylamino-4-methylthio-1,3,5- triazine
213-800-1
1014-69-3
Acute Tox. 4
di(benzothiazol-2-yl) disulphide
204-424-9
120-78-5
Skin Sens. 1
di(tetramethylammonium)(29H,31H-phthalocyanin-N29,N30,N31,N32)disulfonamide disulfonate, cuprate(2-)complex, derivates
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
Di-, tri- and tetrachlorotetradecane
950-299-5
-
yes
di-allate (ISO); S-(2,3-dichloroallyl)-N,N-diisopropylthiocarbamate
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
di-L-para-menthene
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
di-L-para-menthene
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
di-methylamine;di-methylamine ... %
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
di-methylamine;di-methylamine ... %
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
di-n-butyl ether; dibutyl ether
205-575-3
142-96-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
di-n-butylamine
203-921-8
111-92-2
Flam. Liq. 3; Acute Tox. 4
di-n-octylaluminium iodide
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
di-n-pentyl phthalate
205-017-9
131-18-0
Repr. 1B
yes
di-sec-butylamine
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
di-tert-(C12-14)-alkylammonium 2-benzothiazolylthiosuccinate
CM 26-137
406-052-4
125078-60-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
di-tert-butyl peroxide
203-733-6
110-05-4
Org. Perox. E; Flam. Liq. 2; Muta. 2
dialifos (ISO); 2-chloro-1-phthalimidoethyl O,O-diethyl phosphorodithioate
233-689-3
10311-84-9
Acute Tox. 2; Acute Tox. 3
diallyl phthalate
205-016-3
131-17-9
Acute Tox. 4
dialuminium nickel tetraoxide
234-454-8
12004-35-2
Carc. 1A; STOT RE 1; Skin Sens. 1
diamminediisocyanatozinc
GENIPLEX A
401-610-3
122012-52-6
Acute Tox. 4; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
diammonium 1-hydroxy-2-(4-(4-carboxyphenylazo)-2,5-dimethoxyphenylazo)-7-amino-3-naphthalenesulfonate
422-670-7
150202-11-2
Repr. 2; Acute Tox. 3; STOT RE 2
diammonium hexachloroplatinate
240-973-0
16919-58-7
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
diammonium nickel bis(sulfate)
239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
diammonium nickel hexacyanoferrate
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
diammonium peroxodisulphate; ammonium persulphate
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
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