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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 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
2,5-dimercaptomethyl-1,4-dithiane
HR-11
419-770-8
136122-15-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-(2-amino-1,3-thiazol-4-yl)-(Z)-2-methoxyiminoacetyl chloride hydrochloride
31 AC-HCL
410-620-7
119154-86-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-piperazin-1-ylethylamine
205-411-0
140-31-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3,6,9-triazaundecamethylenediamine; tetraethylenepentamine
203-986-2
112-57-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3,6-diazaoctanethylenediamin; triethylenetetramine
203-950-6
112-24-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-chloro-2,4-difluoronitrobenzene
3-CHLORO-2,4-DIFLUORONITROBENZENE
411-980-8
3847-58-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-methylaminomethylphenylamine
SUBSTANCE S44176
414-570-7
18759-96-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
4,4-dimethoxybutylamine
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
acrylic acid, 3-(trimethoxysilyl)propyl ester
419-560-6
4369-14-6
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
amines, polyethylenepoly-; HEPA;polyethlyenepolyamines with the exception of those specified elsewhere in this Annex
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
amines, polyethylenepoly-; HEPA;polyethlyenepolyamines with the exception of those specified elsewhere in this Annex
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
benzoyl chloride
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
condensation product of: 3-(7-carboxyhept-1-yl)-6-hexyl-4-cyclohexene-1,2-dicarboxylic acid with polyamines (primarily; amino-ethyl-piperazine and triethylenetetramine)
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
imazalil sulphate (ISO) powder; 1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate;imazalil sulphate (ISO), aqueous solution; 1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imidazolium hydrogen sulphate
261-351-5
58594-72-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
lithium 3-oxo-1,2(2H)-benzisothiazol-2-ide
LI-BIT
411-690-1
111337-53-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
metam-sodium (ISO); sodium methyldithiocarbamate
205-293-0
137-42-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
sodium 5-n-butylbenzotriazole
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
tetramethylene diacrylate; 1,4-butyleneglycol diacrylate
213-979-6
1070-70-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
chlorocresol; 4-chloro-m-cresol; 4-chloro-3-methylphenol
200-431-6
59-50-7
Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; STOT SE 3; Skin Sens. 1B
1,2,4-trichlorobenzene
204-428-0
120-82-1
Acute Tox. 4; Skin Irrit. 2
1,3-dimethyl-1,3-bis(trimethylsilyl)urea
UTMS
414-180-7
10218-17-4
Acute Tox. 4; Skin Irrit. 2
2-chloro-5-methyl-pyridine
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
3,3,4,4-tetrafluoro-4-iodo-1-butene
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
4-bromo-2-chlorofluorobenzene
4-BROM-2-CHLORFLUORBENZOL; 4-BROMO-2-CHLOROFLUOROBENZENE
405-580-2
60811-21-4
Acute Tox. 4; Skin Irrit. 2
C8-10 alkyl dimethyl hydroxyethyl ammoniumchloride (chain < C8: <3 %, chain = C8: 15 %-70 %, chain = C10: 30 %- 85 %, chain > C10: <3 %)
417-360-3
1379678-84-8
Acute Tox. 4; Skin Irrit. 2
chlorfenson (ISO); 4-chlorophenyl 4-chlorobenzenesulfonate
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
fenoprop (ISO); 2-(2,4,5-trichlorophenoxy)propionic acid
202-271-2
93-72-1
Acute Tox. 4; Skin Irrit. 2
proxan-sodium (ISO); sodium O-isopropyldithiocarbonate
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
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
1,2-dimethylimidazole
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
1-methyl-3-phenyl-1-piperazine
431-180-2
5271-27-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-(4-chloro-2-methylphenoxy)propionic acid;mecoprop (ISO); 2-(4-chloro-o-tolyloxy)propionic acid; (RS)-2-(4-chloro-o-tolyloxy)propionic acid
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-(4-chloro-2-methylphenoxy)propionic acid;mecoprop (ISO); 2-(4-chloro-o-tolyloxy)propionic acid; (RS)-2-(4-chloro-o-tolyloxy)propionic acid
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-isopropyl-4-(N-methyl)aminomethylthiazole
A-87463.0
414-800-6
154212-60-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
3-(2'-phenoxyethoxy)propylamine
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
acifluorfen (ISO); 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoic acid
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
dichlorprop (ISO); 2-(2,4-dichlorophenoxy)propionic acid
204-390-5
120-36-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
disul (ISO); 2-(2,4-dichlorophenoxy)ethyl hydrogensulphate; 2,4-DES
205-259-5
149-26-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
MCPA (ISO); 4-chloro-o-tolyloxyacetic acid
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
methyltriphenylphosphonium chloride
METHYL-TPP-CHLORID; MTPP-CHLORID
418-400-2
1031-15-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
oxydiethylene bis(chloroformate)
203-430-9
106-75-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
salts of mecoprop
-
-
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
sodium 5-[2-chloro-4-(trifluoromethyl) phenoxy]-2-nitrobenzoate; acifluorfen-sodium
263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
(2S, 5R)-6,6-dibromo-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1,2-benzisothiazol-3(2H)-one;1,2-benzisothiazolin-3-one
220-120-9
2634-33-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 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
E-ethyl-4-oxo-4-phenylcrotonate
BAE; BENZOYLACRYLATE D'ETHYLE; BENZOYLACRYLATE D'ÉTHYLE (TRANS); BENZOYLACRYLIC ACID ETHYL ESTER; BENZOYLACRYLSÄURE ETHYLESTER
408-040-4
15121-89-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
magnesium bis((R)-2-(2,4-dichlorophenoxy)propionate)
DUPLOSAN-DP-MAGNESIUM
413-360-2
164058-21-3
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
potassium 2-(2,4-dichlorophenoxy)-(R)-propionate
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of: trans-(2R)-5-acetoxy-1,3-oxathiolane-2-carboxylic acid; cis-(2R)-5-acetoxy-1,3-oxathiolane-2-carboxylic acid
ACETOXYACID
411-660-8
147027-04-1
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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