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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 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-acetoxymethylene-4-acetylphenylacetate
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-alkoyloxyethyl hydrogen maleate, where alkoyl represents (by weight 70 to 85 % unsaturated octadecoyl, 0.5 to 10 % saturated octadecoyl, and 2 to 18 % saturated hexadecoyl
ATRAC 869
417-960-5
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-amino-2-methylpropanol
204-709-8
124-68-5
Eye Irrit. 2; Skin Irrit. 2
2-amino-4,6-dinitrophenol; picramic acid;2-amino-4,6-dinitrophenol; picramic acid [≥ 20 % water]
202-544-6
96-91-3
Acute Tox. 4
2-amino-4,6-dinitrophenol; picramic acid;2-amino-4,6-dinitrophenol; picramic acid [≥ 20 % water]
202-544-6
96-91-3
Expl. 1.1; Acute Tox. 4
2-amino-4-(trifluoromethyl)benzenethiol hydrochloride
429-560-8
4274-38-8
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
2-amino-4-bromo-5-chlorobenzoic acid
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
2-amino-4-chloro-6-methoxypyrimidine
DPX N6186; N 6186
410-050-9
5734-64-5
Acute Tox. 4
2-amino-4-dimethylamino-6-trifluoroethoxy-1,3,5-triazine
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
2-amino-5-methylthiazole
2-AMINO-5-METHYLTHIAZOL
423-800-5
7305-71-7
Acute Tox. 4; STOT RE 2
2-amino-6-ethoxy-4-methylamino-1,3,5-triazine
DPX-D-7556
403-580-7
62096-63-3
Acute Tox. 4
2-aminoethanol; ethanolamine
205-483-3
141-43-5
Acute Tox. 4; Skin Corr. 1B
2-aminoethyldimethylamine; 2-dimethylaminoethylamine
203-541-2
108-00-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
2-aminophenol
202-431-1
95-55-6
Muta. 2; Acute Tox. 4
2-aminopropane; isopropylamine
200-860-9
75-31-0
Flam. Liq. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2-aminosulfonyl-N, N-dimethylnicotinamide
DAM 520
413-440-7
112006-75-4
Skin Sens. 1
2-Benzotriazol-2-yl-4,6-di-tert-butylphenol; UV-320
223-346-6
3846-71-7
yes
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
2-benzyl-2-methyl-3-butenitrile
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
2-bromo-1-(2-furyl)-2-nitroethylene
EF-40
406-110-9
35950-52-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-bromo-2-nitropropanol
DEBROPOL
407-030-7
24403-04-1
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-bromo-4,6-difluoroaniline
429-430-0
444-14-4
Acute Tox. 4
2-bromo-5-hydroxy-4-methoxybenzaldehyde
426-540-0
2973-59-3
Skin Sens. 1
2-bromomalonaldehyde
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
2-bromopropane
200-855-1
75-26-3
Flam. Liq. 2; Repr. 1A; STOT RE 2
2-butanone-O, O',O''-(phenylsilylidyne)trioxime
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
2-butoxyethanol; ethyleneglycol monobutyl ether; butyl cellosolve
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-butoxyethyl acetate; butylglycol acetate
203-933-3
112-07-2
Acute Tox. 4
2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one hydrochloride
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
2-butyl-2-ethyl-1,5-diaminopentane
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-butyl-4-chloro-5-formylimidazole
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
2-butyryl-3-hydroxy-5-thiocyclohexan-3-yl-cyclohex-2-en-1-one
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
2-chloracetamide
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
2-chloro-1,3,5-trinitrobenzene
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
2-chloro-3-trifluoromethylpyridine
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-chloro-4,5-difluorobenzoic acid
2-CHLORO-4,5-DIFLUORO BENZOIC ACID; BA-6; CDFBA
405-380-5
110877-64-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-chloro-4-(methylsulfonyl)benzoic acid
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
2-chloro-4-fluoro-5-nitrophenyl(isobutyl)carbonate
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
2-chloro-4-nitroaniline
204-502-2
121-87-9
Acute Tox. 4
2-chloro-5-chloromethylthiazole
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
2-chloro-5-methyl-pyridine
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
2-chloro-5-sec-hexadecylhydroquinone
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-chloro-6-(ethylamino)-4-nitrophenol
ROT CO
411-440-1
131657-78-8
Acute Tox. 4; Skin Sens. 1
2-chloro-6-fluoro-phenol
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-chloro-N-(4-methylphenyl)acetamide
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
2-chloro-p-toluenesulfochloride
2-CHLOR-4-TOLUOLSULFONYLCHLORID
412-890-1
42413-03-6
Skin Corr. 1B; Skin Sens. 1
2-chlorobenzaldehyde; o-chlorobenzaldehyde
201-956-3
89-98-5
Skin Corr. 1B
2-chlorobenzonitrile
212-836-5
873-32-5
Acute Tox. 4; Eye Irrit. 2
2-chloroethanol; ethylene chlorohydrin
203-459-7
107-07-3
Acute Tox. 2; Acute Tox. 1
2-chloromethyl-3,4-dimethoxypyridinium chloride
B8510-020; CHLORMETHYLPYRIDIN; CHLORMETHYLPYRIDINE; CHLOROMETHYLPYRIDINE
416-440-5
72830-09-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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