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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 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-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-dinitrotoluene
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
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
2,6-dichloro-4-nitroanisole
T 1049
403-350-6
17742-69-7
Acute Tox. 3
2,6-dichloro-4-trifluoromethylaniline
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
2,6-diethylaniline
209-445-7
579-66-8
Acute Tox. 4
2,6-dimethylheptan-4-one; di-isobutyl ketone
203-620-1
108-83-8
Flam. Liq. 3; STOT SE 3
2,6-dinitrophenol
209-357-9
573-56-8
Acute Tox. 3; STOT RE 2
2,6-dinitrotoluene
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,6-xylenol
209-400-1
576-26-1
Acute Tox. 3; Skin Corr. 1B
2,6-xylidine; 2,6-dimethylaniline
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
2,7,11-trimethyl-13-(2,6,6-trimethylcyclohex-1-en-1-yl)tridecahexaen-2,4,6,8,10,12-al
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
2,7-naphthalenedisulfonic acid, nickel(II) salt
-
72319-19-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
2,9-bis(3-(diethylamino)propylsulfamoyl)quino(2,3-b)acridine-7,14-dione
PIGMENT ADDITIV AC; PIGMENTADDITIV AC
404-230-6
164578-11-4
Skin Sens. 1
2-((4-(ethyl-(2-hydroxyethyl)amino)-2-methylphenyl)azo)-6-methoxy-3-methyl-benzothiazolium methylsulfate
FAT 40'398; FAT 40'398/E
411-100-2
136213-73-5
STOT RE 2; Skin Sens. 1
2-((4-amino-2-nitrophenyl)amino)benzoic acid
RO 1082
411-260-3
117907-43-4
Eye Dam. 1; Skin Sens. 1
2-((4-methyl-2-nitrophenyl)amino)ethanol
METHYLGELB
408-090-7
100418-33-5
Acute Tox. 4; Skin Sens. 1
2-(1-methylpropyl)-4-tert-butylphenol
2S4TBP
421-740-4
51390-14-8
Skin Corr. 1B
2-(10-oxo-10H-9-oxa-10-phosphaphenanthren-10-ylmethyl)succinic acid
426-480-5
63562-33-4
Skin Sens. 1
2-(2,4-dichlorophenyl)-1-(1H—1,2,4-triazol-1-yl)pent-4-en-2-ol
TAA
407-850-5
89544-40-1
Acute Tox. 4; Eye Dam. 1
2-(2,4-dichlorophenyl)-2-(2-propenyl)oxirane
EPO
411-210-0
89544-48-9
Skin Irrit. 2; Skin Sens. 1
2-(2-(2-hydroxyethoxy)ethyl)-2-aza-bicyclo[2.2.1]heptane
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 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-(2-aminoethylamino)ethanol; (AEEA)
203-867-5
111-41-1
Repr. 1B; Skin Corr. 1B; Skin Sens. 1
2-(2-bromoethoxy)anisole
GUAIACOL-O-ETHYLBROMIDE
402-010-4
4463-59-6
Acute Tox. 4
2-(2-butoxyethoxy)ethanol; diethylene glycol monobutyl ether
203-961-6
112-34-5
Eye Irrit. 2
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