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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
G 19-675 ZP
403-920-4
107551-67-7
Acute Tox. 4; Eye Irrit. 2
acetophenone
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
ammonium chloride
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
copper(II) carbonate-copper(II) hydroxide (1:1)
235-113-6
12069-69-1
Acute Tox. 4; Eye Irrit. 2
dazomet (ISO);tetrahydro-3,5-dimethyl-1,3,5- thiadiazine-2-thione
208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
dichlorophen (ISO)
202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
fenson (ISO); 4-chlorophenyl benzenesulphonate
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
hexazinone (ISO);3-cyclohexyl-6-dimethylamino-1-methyl-1,2,3,4-tetrahydro-1,3,5-triazine-2,4-dione
257-074-4
51235-04-2
Acute Tox. 4; Eye Irrit. 2
imidazo[1,2-b]pyridazin hydrochloride
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
methyl-2-[(aminosulfonyl)methyl]benzoate
N 5297
419-010-5
112941-26-1
Acute Tox. 4; Eye Irrit. 2
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide
NYLOSTAB S-EED; NYSEED
419-710-0
42774-15-2
Acute Tox. 4; Eye Irrit. 2
oxalic acid diethylester; diethyl oxalate
202-464-1
95-92-1
Acute Tox. 4; Eye Irrit. 2
perfluidone (ISO); 1,1,1-trifluoro-N-(4-phenylsulphonyl-o-tolyl)methanesulphonamide
253-718-3
37924-13-3
Acute Tox. 4; Eye Irrit. 2
reaction mass of 5-heptyl-1,2,4- triazol-3-ylamine and 5-nonyl-1,2,4-triazol-3-ylamine
PK 323
401-940-8
-
Acute Tox. 4; Eye Irrit. 2
secbumeton (ISO);2-sec-butylamino-4-ethylamino-6-methoxy-1,3,5-triazine
247-554-1
26259-45-0
Acute Tox. 4; Eye Irrit. 2
potassium 2-hydroxycarbazole-1-carboxylate
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
troclosene sodium, dihydrate
610-700-3
51580-86-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
1,2-dichlorobenzene; o-dichlorobenzene
202-425-9
95-50-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,4,5-T (ISO); 2,4,5-trichlorophenoxy acetic acid
202-273-3
93-76-5
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
dimercury dichloride; mercurous chloride; calomel
233-307-5
10112-91-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
morfamquat (ISO); 1,1'-bis(3,5-dimethylmorpholinocarbonylmethyl)-4,4'-bipyridilium ion
-
7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
morfamquat dichloride
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
morfamquat sulfate
-
29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
salts and esters of 2,4,5-T; salts and esters of 2,4,5-trichlorophenoxy acetic acid
-
-
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
ε-caprolactam
203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,5-naphthylene diisocyanate
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
8,9-dinorborn-5-ene-2,3-dicarboxylic anhydride
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
maleic acid
203-742-5
110-16-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
zinc bis(diethyldithiocarbamate)
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
2,4,5-trichlorophenol
202-467-8
95-95-4
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2,4,6-tris(dimethylaminomethyl)phenol
202-013-9
90-72-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-(3,4-dichlorophenyl)-4-methyl-1,2,4-oxadiazolidinedione; methazole
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-butoxyethanol; ethyleneglycol monobutyl ether; butyl cellosolve
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
allidochlor (ISO); N,N-diallylchloroacetamide
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
copper sulphate
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
dichlone (ISO); 2,3-dichloro-1,4-naphthoquinone
204-210-5
117-80-6
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
dodine(ISO); dodecylguanidinium acetate
219-459-5
2439-10-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
guaiacol
201-964-7
90-05-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
guanidinium chloride; guanadine hydrochloride
200-002-3
50-01-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
iron (II) sulfate
231-753-5
7720-78-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
iron (II) sulfate (1:1) heptahydrate; sulfuric acid, iron(II) salt (1:1), heptahydrate; ferrous sulfate heptahydrate
616-510-7
7782-63-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
N,N-diethyl-m-toluamide; deet
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
naled (ISO); 1,2-dibromo-2,2-dichloroethyl dimethyl phosphate
206-098-3
300-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
penthachloronaphthalene
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
resorcinol; 1,3-benzenediol
203-585-2
108-46-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
1,4-bis(2,3 epoxypropoxy)butane; butanedioldiglycidyl ether
219-371-7
2425-79-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-diethylaminoethyl methacrylate
203-275-7
105-16-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-dimethylaminoethyl methacrylate
220-688-8
2867-47-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-ethyl-N-methyl-N-(3-methylphenyl)butanamide
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
4-chloro-3,5-dimethylphenol
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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