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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 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
3,4-dinitrotoluene
210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
3,4-xylenol
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B
3,5,5-trimethylcyclohex-2-enone; isophorone
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
3,5-bis-(tetradecyloxycarbonyl)benzenesulfinic acid
AF-389
407-990-7
141915-64-2
Skin Sens. 1
3,5-dichloro-2,4-difluorobenzoyl fluoride
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
3,5-dichloro-2,6-difluoropyrdine-4-amine
220-630-1
2840-00-8
Acute Tox. 4
3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)aniline
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
3,5-dichloro-4-(1,1,2,2-tetrafluoroethoxy)aniline
DCATFOB; XRD 473 ANILINE
401-790-3
104147-32-2
Acute Tox. 4
3,5-dimethylbenzoyl chloride
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
3,5-dinitrotoluene
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
3,5-xylenol; 3,5-dimethylphenol
203-606-5
108-68-9
Acute Tox. 3; Skin Corr. 1B
3,6,9,12-tetra-azatetradecamethylenediamine; pentacthylenehexamine
223-775-9
4067-16-7
Skin Corr. 1B; Skin Sens. 1
3,6,9-triazaundecamethylenediamine; tetraethylenepentamine
203-986-2
112-57-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3,6-diazaoctanethylenediamin; triethylenetetramine
203-950-6
112-24-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3,6-dichloro-o-anisic acid, compound with dimethylamine (1:1)
218-951-7
2300-66-5
Eye Irrit. 2
3,7-dimethylocta-2,6-dienenitrile
225-918-0
5146-66-7
Muta. 1B
3,7-dimethyloctanenitrile
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
3,9-bis(2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy-1,1-dimethylethyl)-2,4,8,10-tetraoxaspiro[5.5]undecane
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
3-((2-nitro-4-(trifluoromethyl)phenyl)amino)propane-1,2-diol
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
3-((4-(bis(2-hydroxyethyl)amino)-2-nitrophenyl)amino)-1-propanol
IMEXINE FAG
410-910-3
104226-19-9
Skin Sens. 1
3-((C12-18)-acylamino)-N-(2-((2-hydroxyethyl)amino)-2-oxoethyl)-N,N-dimethyl-1-propanaminium chloride
427-370-1
164288-56-6
Eye Dam. 1
3-(2'-phenoxyethoxy)propylamine
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
3-(2-(diaminomethyleneamino)thiazol-4-ylmethylthio)propionitrile
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 1
3-(2-bromopropionoyl)-4,4-dimethyl-1,3-oxazolan-2-one
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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
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