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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 May 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
dichloroacetylene
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
dichlorodioctyl stannane
222-583-2
3542-36-7
Repr. 1B; Acute Tox. 2; STOT RE 1
dichloromethane; methylene chloride
200-838-9
75-09-2
Carc. 2
dichlorophen (ISO)
202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
dichlorprop (ISO); 2-(2,4-dichlorophenoxy)propionic acid
204-390-5
120-36-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
dichlorprop-P (ISO); (+)-R-2-(2,4-dichlorophenoxy)propionic acid
D-2,4-DP; DICHLORPROP-P; DUPLOSAN DP-ACID
403-980-1
15165-67-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
dichlorvos (ISO); 2,2-dichlorovinyl dimethyl phosphate
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
diclobutrazole (ISO);(R*, R*)-(±)-β-[(2,4-dichlorop henyl)methyl]-α-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol; (2RS, 3RS)-1-(2,4-dichlorophenyl)-4,4-dimethyl-2- (1H—1,2,4-triazol-1yl)pentan-3-ol
620-436-0
75736-33-3
Eye Irrit. 2
diclofop-methyl (ISO)methyl 2-(4-(2,4-dichlorophenoxy)phenoxy)propionate; methyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate
257-141-8
51338-27-3
Acute Tox. 4; Skin Sens. 1
dicofol (ISO); 2,2,2-trichloro-1,1-bis(4-chlorophenyl)ethanol
204-082-0
115-32-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
dicopper chloride trihydroxide
215-572-9
1332-65-6
Acute Tox. 4; Acute Tox. 3
dicopper oxide; copper (I) oxide
215-270-7
1317-39-1
Acute Tox. 4; Eye Dam. 1
dicoumarol; 4,4'-dihydroxy-3,3'-methylenebis(2H-chromen-2-one)
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
dicrotophos (ISO); (Z)-2-dimethylcarbamoyl-1-methylvinyl dimethyl phosphate
205-494-3
141-66-2
Acute Tox. 2; Acute Tox. 3
dicyclohexylamine
202-980-7
101-83-7
Acute Tox. 4; Skin Corr. 1B
dicyclohexylammonium nitrite
221-515-9
3129-91-7
Acute Tox. 4
dicyclohexylcarbodiimide
208-704-1
538-75-0
Acute Tox. 3; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
dicyclopentyldimethoxysilane
DCPMS; DYNASYLAN 9415; EURENOR 5023; SAN-30; WACKER SILAN CP2-DIMETHOXY; Z-6228
404-370-8
126990-35-0
Skin Irrit. 2; Eye Dam. 1
didecyldimethylammonium chloride
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
dieldrin (ISO)
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
diethanolamine perfluorooctane sulfonate
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
diethanolamine salt of 4-CPA
-
-
Acute Tox. 4
diethyl 2,4-dihydroxycyclodisiloxane-2,4-diylbis(trimethylene)diphosphonate, tetrasodium salt, reaction products with disodium metasilicate
SIFOSIL; SIFOSIL KONZENTRAT G 96-00 FEST
401-770-4
148324-78-1
Skin Corr. 1B; Acute Tox. 4
diethyl ether; ether
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
diethyl thiophosphoryl (Z)-(2-aminothiazol-4-yl)methoxyimino acetate
DAMA
426-790-0
162208-27-7
Acute Tox. 4; STOT RE 2; Skin Sens. 1
diethyl(ethyldimethylsilanolato) aluminium
CS 100; SILOXAL
401-160-8
55426-95-4
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A
diethyl[(p-ethoxyanilino)methylene]malonate
431-430-0
103976-28-9
Acute Tox. 4
diethylamine
203-716-3
109-89-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
diethylcarbamoyl chloride
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
diethyldimethylammonium hydroxide
DIETHYLDIMETHYLAMMONIUMHYDROXIDE
419-400-5
95500-19-9
Acute Tox. 4; Skin Corr. 1A
diethylmercury
211-000-7
627-44-1
Acute Tox. 2; Acute Tox. 1; STOT RE 2
diethylmethoxyborane
425-380-9
7397-46-8
Pyr. Liq. 1; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
diethylmethylbenzenediamine
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
diethylzinc
209-161-3
557-20-0
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
diethyl{4-[1,5,5-tris(4-diethylaminophenyl)penta-2,4-dienylidene]cyclohexa-2,5-dienylidene}ammonium butyltriphenylborate
IRB
418-070-1
141714-54-7
Skin Sens. 1
difethialone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one
600-594-7
104653-34-1
Repr. 1B; Acute Tox. 1; STOT RE 1
digitoxin
200-760-5
71-63-6
Acute Tox. 3; STOT RE 2
diisooctyl phthalate
248-523-5
27554-26-3
Repr. 1B
diisopropyl ether
203-560-6
108-20-3
Flam. Liq. 2; STOT SE 3
diisopropylamine
203-558-5
108-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
diketene; diketen
211-617-1
674-82-8
Flam. Liq. 3; Acute Tox. 4
dilauroyl peroxide
203-326-3
105-74-8
Org. Perox. D
dilithium 6-acetamido-4-hydroxy-3-(4-((2-sulphonatooxy)ethylsulphonyl) phenylazo)naphthalene-2-sulphonate
REACTIVE ORANGE F-64 258 FW
401-010-1
106027-83-2
Skin Sens. 1
dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3, N4-η:N3', N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)
BLUE GS 1259 R5
407-230-4
126637-70-5
Acute Tox. 4; Skin Sens. 1
dimefox (ISO); tetramethylphosphorodiamidic fluoride
204-076-8
115-26-4
Acute Tox. 1; Acute Tox. 2
dimepiperate (ISO);S-(1-methyl-1-phenylethyl) piperidine-1-carbothioate
262-784-2
61432-55-1
Acute Tox. 4
dimercury dichloride; mercurous chloride; calomel
233-307-5
10112-91-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
dimercury dicyanide oxide; mercuric oxycyanide
215-629-8
1335-31-5
Expl. 1.1; Acute Tox. 3; STOT RE 2
dimethachlor (ISO); 2-chloro-N-(2,6-dimethylphenyl)-N-(2-methoxyethyl)acetamide
256-625-6
50563-36-5
Acute Tox. 4; Skin Sens. 1
dimethenamid-P (ISO); 2-chloro-N-(2,4-dimethyl-3- thienyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide
605-329-9
163515-14-8
Acute Tox. 4; Skin Sens. 1
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