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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 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
2,4,6-trinitro-m-cresol
210-027-1
602-99-3
Expl. 1.1; Acute Tox. 4
2,4,6-trinitro-m-xylene
211-187-5
632-92-8
Expl. 1.1; Acute Tox. 4; STOT RE 2
2,4,6-trinitroanisole
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
2,4,6-trinitrophenol; picric acid
201-865-9
88-89-1
Expl. 1.1; Acute Tox. 3
2,4,6-trinitroresorcinol; styphnic acid
201-436-6
82-71-3
Expl. 1.1; Acute Tox. 4
2,4,6-trinitrotoluene; TNT
204-289-6
118-96-7
Expl. 1.1; Acute Tox. 3; STOT RE 2
2,4,6-tris(dimethylaminomethyl)phenol
202-013-9
90-72-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2,4-bis(((2-(dimethylammonio)ethyloxy)carbonyl)phen-2-ylazo)benzene-1,3-diol sulfate
429-610-9
1030366-98-3
Acute Tox. 4; Eye Dam. 1
2,4-bis(((2-(dimethylammonio)ethyloxy)carbonyl)phen-2-ylazo)benzene-1,3-diolbis(methanesulfonate)
429-600-4
1026988-42-0
Acute Tox. 4; Eye Dam. 1
2,4-bis[2,2'-[2-(N, N-dimethylamino)ethyloxycarbonyl]phenylazo]-1,3-dihydroxybenzene, dihydrochloride
BASISCH GELB 8511
407-010-8
118208-02-9
Acute Tox. 4; Eye Dam. 1
2,4-D (ISO); 2,4-dichlorophenoxyacetic acid
202-361-1
94-75-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1; Skin Sens. 1
2,4-DB (ISO); 4-(2,4-dichlorophenoxy)butyric acid
202-366-9
94-82-6
Acute Tox. 4
2,4-di-tert-butylcyclohexanone
CYCLOWOOD
405-340-7
13019-04-0
Skin Irrit. 2
2,4-diamino-3,5-diethyltoluene; 2,4-diethyl-6-methyl-1,3-benzenediamine
218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,4-diamino-5-[4-[(2-sulfoxyl ethyl)sulfonyl]phenylazo]benzenesulfonic acid
424-870-1
27624-67-5
Expl. 1.1; Eye Dam. 1
2,4-diamino-5-methoxymethylpyrimidine
DAMP
410-330-0
54236-98-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,4-diaminoanisole sulphate
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
2,4-diaminoanisole; 4-methoxy-m-phenylenediamine
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
2,4-dichloro-3-ethyl-6-nitrophenol
2,4-DICHLORO-3-ETHYL-6-NITROPHENOL
420-740-1
99817-36-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
2,4-dichloro-3-ethylphenol
PM 9879
401-060-4
121518-45-4
Skin Corr. 1B
2,4-dichloro-5-fluorobenzoylchloride
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2,4-dichlorophenol
204-429-6
120-83-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
2,4-diethyl-1,5-pentanediol
429-310-8
57987-55-0
Eye Dam. 1
2,4-difluoro-α-(1H-1,2,4-triazol-1-yl)acetophenone hydrochloride
UK-51,060-01
412-390-3
86386-75-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,4-dihydro-4-(4-(4-(4-hydroxyphenyl)-1-piperazinyl)phenyl)-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one
434-820-9
106461-41-0
STOT RE 2
2,4-dihydroxy-N-(2-methoxyphenyl)benzamide
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
2,4-dimethyl-6-(1-methyl-pentadecyl)phenol
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
2,4-dimethylhexane
209-649-6
589-43-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dimethylpentan-3-one; di-isopropyl ketone
209-294-7
565-80-0
Flam. Liq. 2; Acute Tox. 4
2,4-dimethylpentane
203-548-0
108-08-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dinitroaniline
202-553-5
97-02-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
2,4-dinitrophenol
200-087-7
51-28-5
Acute Tox. 3; Acute Tox. 2; STOT RE 1
2,4-xylenol
203-321-6
105-67-9
Acute Tox. 3; Skin Corr. 1B
2,5,7,7-tetramethyloctanal
LYRISAL
405-690-0
114119-97-0
Skin Irrit. 2; Skin Sens. 1
2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane
MR-8A; MR-N2; NBDI
411-280-2
161973-12-2
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
2,5-dibutoxy-4-(morpholin-4-yl)benzenediazonium 4-methylbenzenesulfonate
DIAZO W 6623-TS
413-290-2
93672-52-7
Self-react. C; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,5-dihydroxy-5-methyl-3-(morpholin-4-yl)-2-cyclopenten-1-one
430-170-5
114625-74-0
Acute Tox. 4
2,5-dimercaptomethyl-1,4-dithiane
HR-11
419-770-8
136122-15-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,5-dimethylhexane
209-745-8
592-13-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,5-dinitrophenol
206-348-1
329-71-5
Acute Tox. 3; STOT RE 2
2,5-dinitrotoluene
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,5-dioxopyrrolidin-1-yl N-{[methyl[[2-(1-methylethyl)-4-thiazoly]methyl]amino]carbonyl}-L-Valinate
424-660-8
-
STOT RE 2; Eye Dam. 1; Skin Sens. 1
2,5-xylenol
202-461-5
95-87-4
Acute Tox. 3; Skin Corr. 1B
2,6,6,7,8,8-hexamethyldecahydro-2H-indeno[4,5-b]furan
440-030-5
338735-71-0
Skin Irrit. 2; Eye Dam. 1
2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one
429-460-4
7078-98-0
Skin Sens. 1
2,6-bis(2,3,4-trihydroxybenzyl)-p-cresol ester with 6-diazo-5,6-dihydro-5-oxo-1-naphthalenesulfonate
444-250-2
144111-81-9
Self-react. C
2,6-bis-(2-(4-(4-amino-phenylamino)-phenylazo)-1,3-dimethyl-3H-imidazolium)-4-dimethylamino-1,3,5-triazine, dichloride
VIOLETT MIP 3250
424-120-1
174514-06-8
Eye Dam. 1
2,6-diamino-3,5-diethyltoluene; 4,6-diethyl-2-methyl-1,3-benzenediamine
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,6-diamino-3-((pyridine-3-yl)azo)pyridine
AZOGELB
421-430-9
28365-08-4
Acute Tox. 4; STOT RE 2
2,6-dichloro-1-fluoropyridiniumtetrafluoroborate
FPB 800
427-400-1
140623-89-8
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
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