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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 May 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
mercury difulminate; mercuric fulminate; fulminate of mercury;mercury difulminate; mercuric fulminate; fulminate of mercury [≥ 20 % phlegmatiser]
211-057-8
628-86-4
Unst. Expl.; Acute Tox. 3; STOT RE 2
salts of picric acid
-
-
Unst. Expl.; Acute Tox. 3
oxydiethylene dinitrate; diethylene glycol dinitrate; digol dinitrate;oxydiethylene dinitrate; diethylene glycol dinitrate; digol dinitrate [>25 % phlegmatiser]
211-745-8
693-21-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
glycerol trinitrate; nitroglycerine;glycerol trinitrate; nitroglycerine [>40 % phlegmatiser]
200-240-8
55-63-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
ethylene dinitrate; ethylene glycol dinitrate
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;pentaerythritol tetranitrate; pentaerythrite tetranitrate; P.E.T.N.;[>20 % phlegmatiser]
201-084-3
78-11-5
Unst. Expl.
mannitol hexanitrate; nitromannite;mannitol hexanitrate; nitromannite;[>40 % phlegmatiser]
239-924-6
15825-70-4
Unst. Expl.
ethyl nitrate
210-903-3
625-58-1
Unst. Expl.
metazachlor (ISO); 2-chloro-N-(2,6-dimethylphenyl)-N-(1H-pyrazol-1-ylmethyl)-acetamide
266-583-0
67129-08-2
Skin Sens. 1B; Carc. 2
trimethoxyvinylsilane; trimethoxy(vinyl)silane
220-449-8
2768-02-7
Skin Sens. 1B
tolclofos-methyl (ISO); O-(2,6-dichloro-p-tolyl)-O,O-dimethyl thiophosphate
260-515-3
57018-04-9
Skin Sens. 1B
muscalure; cis-tricos-9-ene
248-505-7
27519-02-4
Skin Sens. 1B
linalool; 3,7-dimethyl-1,6-octadien-3-ol; dl-linalool
201-134-4
78-70-6
Skin Sens. 1B
licareol; (R)-3,7-dimethyl-1,6-octadien-3-ol; l-linalool
204-811-2
126-91-0
Skin Sens. 1B
coriandrol; (S)-3,7-dimethyl-1,6-octadien-3-ol; d-linalool
204-810-7
126-90-9
Skin Sens. 1B
benzyl salicylate
204-262-9
118-58-1
Skin Sens. 1B
phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
isoeugenol
202-590-7
97-54-1
Skin Sens. 1A
hydroxyisohexyl 3-cyclohexene carboxaldehyde (INCI); reaction mass of 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
641-410-5
130066-44-3
Skin Sens. 1A
4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
250-863-4
31906-04-4
Skin Sens. 1A
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
257-187-9
51414-25-6
Skin Sens. 1A
(Z)-2-methoxy-4-(prop-1-enyl)phenol
227-633-7
5912-86-7
Skin Sens. 1A
(E)-2-methoxy-4-(prop-1-enyl)phenol
227-678-2
5932-68-3
Skin Sens. 1A
acequinocyl (ISO); 3-dodecyl-1,4-dioxo-1,4-dihydronaphthalen-2-yl acetate
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
α-[3-(1-oxoprop-2-enyl)l-1-oxypropyl]dimethoxysilyloxy-ω-[3(1-oxoprop-2-enyl)-1-oxypropyl]dimethoxysilyl poly(dimethylsiloxane)
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
zoxamide (ISO); (RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide
605-037-1
156052-68-5
Skin Sens. 1
tritosulfuron (ISO) (containing ≤0,02 % AMTT); 1-[4-methoxy-6-(trifluoromethyl)-1,3,5-triazin-2-yl]-3-[2-(trifluoromethyl)benzenesulfonyl]urea (containing ≤ 0,02 % AMTT)
604-291-0
142469-14-5
Skin Sens. 1
trisodium bis[(3'-nitro-5'-sulfonato(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
RED JB 747
418-220-4
-
Skin Sens. 1
trisodium 7-(4-(6-fluoro-4-(2-(2-vinylsulphonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulphonate
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
trisodium 4-hydroxy-6-(sulfonatomethylamino)-5-(2-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2-sulfonate
430-280-3
844491-96-9
Skin Sens. 1
trisodium 3-amino-6,13-dichloro-10-((3-((4-chloro-6-(2-sulfophenylamino)-1,3,5-triazin-2-yl)amino)propyl) amino)-4,11-triphenoxydioxazinedisulfonate
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
tris(nonylphenyl) phosphite
247-759-6
26523-78-4
Skin Sens. 1
yes
tris(2-(2-hydroxyethoxy)ethyl)ammonium 3-acetoacetamido-4-methoxybenzenesulfonate
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
trans—N-methyl-2-styryl-[4'- aminomethine-(1-acetyl-1-(2- methoxyphenyl)acetamido)]py ridinium acetate
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
tetrasodium [7-(2,5-dihydroxy-KO2-7-sulfonato-6-[4-(2,5,6-trichloro-pyrimidin-4-ylamino)phenylazo]-(N1,N7-N)1-naphthylazo)-8-hydroxy-KO8-naphthalene-1,3,5-trisulfonato(6)]cuprate(II)
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
tetrasodium 4-hydroxy-5-[4-[3-(2-sulfatoethanesulfonyl)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]-3-(1-sulfonatonaphthalen-2-ylazo)naphthalene-2,7-disulfonate
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
tetrasodium 4-amino-5-hydroxy-6-(4-(2-(2-(sulfonatooxy)ethylsulfonyl)ethylcarbamoyl)phenylazo)-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
tetrasodium 3,3'-(piperazine-1,4-diylbis((6-chloro-1,3,5-triazine-2,4-diyl)imino(2-acetamido)-4,1-phenyleneazo))bis(naphthalene-1,5-disulphonate)
AMARELO INDOSOL SF-2RL; INDOSOL GELB SF-2RL; INDOSOL YELLOW SF-2RL; JAUNE INDOSOL SF-2RL; JAUNE WK 1913; SOLAR GOLDEN YELLOW R; YELLOW WK 1913
400-010-9
81898-60-4
Skin Sens. 1
tetrasodium 2-(6-chloro-4-(4-(2,5-dimethyl-4-(2,5-disulphonatophenylazo)phenylazo)-3-ureidoanilino)-1,3,5-triazin-2-ylamino)benzene-1,4-disulphonate
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
tetrasodium 1,2-bis(4-fluoro-6- [5-(1-amino-2-sulfonatoanthra chinon-4-ylamino)-2,4,6- trimethyl-3-sulfonatopheny lamino]-1,3,5-triazin-2- ylamino)ethane
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
tetrapotassium 2-(4-(5-(1-(2,5- disulfonatophenyl)-3-ethoxycar bonyl-5-hydroxypyrazol-4- yl)penta-2,4-dienylidene)-3- ethoxycarbonyl-5-oxo-2-pyra zolin-1-yl)benzene-1,4- disulfonate
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
tetralithium 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo)naphthalene-2,7-disulfonate
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
tetraethyl N, N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate
429-270-1
136210-30-5
Skin Sens. 1
tetrabutylammonium butyltriphenylborate
P3B
418-080-4
120307-06-4
Skin Sens. 1
tetraammonium 5-(4-(7-amino-1-hydroxy-3-sulfonato-2-naphthylazo)-6-sulfonato-1-naphthylazo)isophthalate
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1
strontium 2-[(2-hydroxy-6-sulfonato-1-naphthyl)azo]naphthalene-1-sulfonate
427-930-3
250639-69-1
Skin Sens. 1
sodium methyl [(4-aminophenyl)sulphonyl]carbamate; sodium methyl (EZ)-sulfanilylcarbonimidate; asulam-sodium
218-953-8
2302-17-2
Skin Sens. 1
sodium benzoyloxybenzene-4-sulfonate
LU20
405-450-5
66531-87-1
Skin Sens. 1
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