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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
3-(2-chloroethyl)-6,7,8,9-tetra-hydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one monohydrochloride
424-530-0
93076-03-0
Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1
3-(2-ethylhexyloxy)propane-1,2-diol
2-EHOPD; EHOPD; GE-EH; SENSIVA SC 50
408-080-2
70445-33-9
Eye Dam. 1
3-(2H-tetrazol-5-yl)pyridine
5-(3-PYRIDYL)-TETRAZOL
426-810-8
3250-74-6
Eye Dam. 1
3-(3-amino-5-(1-methylguanidino)-1-oxopentylamino-6-(4-amino-2-oxo-2,3-dihydro-pyrimidin-1-yl)-2,3-dihydro-(6H)-pyran-2-carboxylic acid; blasticidin-s
606-640-2
2079-00-7
Acute Tox. 2
3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin; difenacoum
259-978-4
56073-07-5
Repr. 1B; Acute Tox. 1; STOT RE 1
3-(3-methylpent-3-yl)isoxazol-5- ylamine
128719
401-460-9
82560-06-3
Acute Tox. 3; Eye Dam. 1
3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
G 19-675 ZP
403-920-4
107551-67-7
Acute Tox. 4; Eye Irrit. 2
3-(4-aminophenyl)-2-cyano-2-propenoic acid
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
3-(4-chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
3-(4-fluorophenyl)-2-methylpropionylchloride
426-370-7
1017183-70-8
Skin Corr. 1A; Acute Tox. 4
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
257-187-9
51414-25-6
Skin Sens. 1A
3-(6-O-(6-desoxy-α-l-mannopyranosyl-O-(α-d-glucopyranosyl)-(β-d-glucopyranosyl)oxy)-2-(3,4-dihydroxyphenyl)-5,7-dihydroxy-4H-1-benzopyran-4-one
424-170-4
130603-71-3
Skin Sens. 1
3-(benzo[b]thien-2-yl)-5,6-dihydro-1,4,2-oxathiazine-4-oxide
431-030-6
163269-30-5
Acute Tox. 3; STOT RE 2; Eye Dam. 1
3-(bis(2-ethylhexyl)amino methyl)benzothiazole-2(3H)- thione
CM 22-447
402-540-6
105254-85-1
Skin Corr. 1B; Skin Sens. 1
3-(cis-1-propenyl)-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
7-PACA
415-750-8
106447-44-3
Skin Sens. 1
3-(cis-3-hexenyloxy)propanenitril
PARMANYL
415-220-6
142653-61-0
Acute Tox. 3; Acute Tox. 4
3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide; fluxapyroxad
620-041-3
907204-31-3
Lact.
3-(dimethylamino)propylurea
3-(DIMETHYLAMINO)PROPYL UREA; HST 2844
401-950-2
31506-43-1
Eye Dam. 1
3-(hydroxyphenylphosphinyl)propanoic acid
FYROL 3-HPP; HIRETAR-205; PHOSGARD PF 100
411-200-6
14657-64-8
Eye Dam. 1
3-(N-methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol hydrochloride
IMEXINE FAE
403-440-5
93633-79-5
Acute Tox. 4
3-(piperazin-1-yl)-benzo[d]isothiazole hydrochloride
421-310-6
87691-88-1
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
3-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-(E)-2-propenal
425-370-4
93957-50-7
Skin Sens. 1
3-acetyl-1-phenyl-pyrrolidine-2,4-dione
ADDITIVE F6
421-600-2
719-86-8
STOT RE 2
3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione; dehydracetic acid
208-293-9
520-45-6
Acute Tox. 4
3-amino-4-hydroxy-N-(2-methoxyethyl)-benzenesulfonamide
FAT 92.346 B
411-520-6
112195-27-4
Eye Dam. 1; Skin Sens. 1
3-amino-4-hydroxy-N-(3-isopropoxypropyl)benzenesulfonamide hydrochloride
427-780-9
114565-70-7
Acute Tox. 4; Eye Dam. 1
3-amino-9-ethyl carbazole; 9-ethylcarbazol-3-ylamine
205-057-7
132-32-1
Carc. 1B
3-aminobenzene sulphonic acid; metanilic acid
204-473-6
121-47-1
Acute Tox. 4
3-aminobenzylamine
SUBSTANCE S68494
412-230-2
4403-70-7
Acute Tox. 4; Skin Corr. 1B
3-aminomethyl-3,5,5-trimethylcyclohexylamine
220-666-8
2855-13-2
Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
3-aminophenol
209-711-2
591-27-5
Acute Tox. 4
3-aminopropyldiethylamine; N,N-diethyl-1,3-diaminopropane
203-236-4
104-78-9
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-aminopropyldimethylamine; N,N-dimethyl-1,3-diaminopropane
203-680-9
109-55-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-aminopropyltriethoxysilane
213-048-4
919-30-2
Acute Tox. 4; Skin Corr. 1B
3-azidosulfonylbenzoic acid
ASB
405-310-3
15980-11-7
Self-react. C; STOT RE 2; Eye Dam. 1; Skin Sens. 1
3-benzyl-exo-6-nitro-2,4-dioxo-3-aza-cis-bicyclo[3.1.0]hexane
426-750-2
151860-15-0
Skin Sens. 1
3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA)
622-370-8
1522-92-5
yes
3-butoxypropan-2-ol; propylene glycol monobutyl ether
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
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-chloro-2-(isopropylthio)aniline
CA 2272 A
421-700-6
179104-32-6
Skin Irrit. 2
3-chloro-2-methylpropene
209-251-2
563-47-3
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-chloro-4,5,α, α, α-pentafluorotoluene
3-CHLORO-4,5-DIFLUOROBENZOTRIFLUORIDE
401-930-3
77227-99-7
Flam. Liq. 3; Acute Tox. 4
3-chloro-4-(3-fluorobenzyloxy)aniline
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
3-chloro-5-trifluoromethyl-2- pyridylamine
ACTF; P-007
401-670-0
79456-26-1
Acute Tox. 4
3-chloro-6-cyano-bicyclo(2,2,1)heptan-2-one-O-(N-methylcarbamoyl)oxime; triamid
-
15271-41-7
Acute Tox. 2; Acute Tox. 3
3-chloropentane
210-467-4
616-20-6
Flam. Liq. 2; Acute Tox. 4
3-chlorophenol
203-582-6
108-43-0
Acute Tox. 4
3-chloropropene; allyl chloride
203-457-6
107-05-1
Flam. Liq. 2; Carc. 2; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
3-chloropropyl chloroformiate
CHLOROFORMIATE DE CHLORO 3 PROPYLE
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
3-chlorotoluene
203-580-5
108-41-8
Acute Tox. 4
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