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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 10 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
4,4'-methylenebis(2-isopropyl-6-methylaniline)
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
4,4'-methylenebis(2-ethylaniline); 4,4'-methylenebis(2-ethylbenzeneamine)
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
4,4'-methylenebis(2,6-dimethylphenyl cyanate)
AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
4,4'-methylene bis(3-chloro-2,6-di-ethylphenylisocyanate)
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1
4,4'-ethylidenediphenyl dicyanate
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1
4,4'-diaminodiphenylmethane; 4,4'-methylenedianiline
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
4,4'-diamino-2-methylazobenzene
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
4,4'-carbonimidoylbis[N, N-dimethylaniline]
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
4,4'-bis(N-carbamoyl-4-methylbenzenesulfonamide)diphenylmethane
B-TUM
418-770-5
151882-81-4
Carc. 2
4,4'-bis(dimethylamino)benzophenone; Michler's ketone
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol
209-218-2
561-41-1
yes
4,4'-bi-o-toluidine
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
4,4'-(oxy-(bismethylene))-bis-1,3-dioxolane
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
4,4'-(4-iminocyclohexa-2,5-dienylidenemethylene)dianiline hydrochloride; C.I. Basic Red 9
209-321-2
569-61-9
Carc. 1B
4,4'-(1-Methylpropylidene)bisphenol
201-025-1
77-40-7
yes
4,4'-(1,3-phenylene-bis(1-methylethylidene))bis-phenol
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
4'-fluoro-2,2-dimethoxyacetophenone
DMA
407-500-1
21983-80-2
Skin Sens. 1
4'-ethoxy-2-benzimidazoleanilide
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
3a,4,7,7a-tetrahydro-4,7-methanoindene
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
3-tridecyloxy-propyl-ammonium 9-octadecenoate
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
3-propanolide;1,3-propiolactone
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
3-pentanol
209-526-7
584-02-1
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
3-oxoandrost-4-ene-17-β-carboxylic acid
CC14837; SKF 106224
414-990-0
302-97-6
Repr. 2
3-N, N-bis(methoxyethyl)aminoacetanilide
432-530-7
24294-01-7
Acute Tox. 4
3-methylpyrazole
215-925-7
1453-58-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Corr. 1; Eye Dam. 1
3-methylpyrazol-5-yl-dimethylcarbamate; monometilan
-
2532-43-6
Acute Tox. 3
3-methylpentane
202-481-4
96-14-0
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-methylhexane
209-643-3
589-34-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-methylheptane
209-660-6
589-81-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-methylbutan-2-one; methyl isopropyl ketone
209-264-3
563-80-4
Flam. Liq. 2
3-methylaminomethylphenylamine
SUBSTANCE S44176
414-570-7
18759-96-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-methyl-5-phenylpentan-1-al
433-900-0
55066-49-4
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone di-isocyanate
223-861-6
4098-71-9
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
3-iodpropene; allyl iodide
209-130-4
556-56-9
Flam. Liq. 2; Skin Corr. 1B
3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate
259-627-5
55406-53-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1
3-hydroxypropyl methacrylate
220-426-2
2761-09-3
Eye Irrit. 2; Skin Sens. 1
3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate
LUPEROX 610-E-35; LUPEROX 610-E-50; LUPEROX 610-EN-50; LUPEROX 610-M-50; LUPERSOL 610; LUPERSOL 610-M-50
413-910-1
1467668-33-2
Org. Perox. C; Flam. Liq. 3; Skin Irrit. 2
3-hexylheptamethyltrisiloxane
428-700-5
1873-90-1
Acute Tox. 4
3-ethylpentane
210-529-0
617-78-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-ethylhexane
210-621-0
619-99-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-ethyl-3-methylpentane
213-923-0
1067-08-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-ethyl-2-methylpentane
210-187-2
609-26-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
3-ethyl 5 methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
UK-48,340
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
3-dodecyl-(1-(1,2,2,6,6-pentamethyl-4-piperidin)-yl)-2,5-pyrrolidindione
SANDUVOR 3056
411-920-0
106917-30-0
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
3-cyano-3,5,5-trimethylcyclohexanone
ISOPHORONENITRILE, IPN
411-490-4
7027-11-4
Acute Tox. 4; STOT RE 2; Skin Sens. 1
3-chlorotoluene
203-580-5
108-41-8
Acute Tox. 4
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-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-chlorophenol
203-582-6
108-43-0
Acute Tox. 4
3-chloropentane
210-467-4
616-20-6
Flam. Liq. 2; 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-chloro-5-trifluoromethyl-2- pyridylamine
ACTF; P-007
401-670-0
79456-26-1
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-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-2-methylpropene
209-251-2
563-47-3
Flam. Liq. 2; 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-2,4-difluoronitrobenzene
3-CHLORO-2,4-DIFLUORONITROBENZENE
411-980-8
3847-58-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-butoxypropan-2-ol; propylene glycol monobutyl ether
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA)
622-370-8
1522-92-5
yes
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-azidosulfonylbenzoic acid
ASB
405-310-3
15980-11-7
Self-react. C; STOT RE 2; Eye Dam. 1; Skin Sens. 1
3-aminopropyltriethoxysilane
213-048-4
919-30-2
Acute Tox. 4; Skin Corr. 1B
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-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-aminophenol
209-711-2
591-27-5
Acute Tox. 4
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-aminobenzylamine
SUBSTANCE S68494
412-230-2
4403-70-7
Acute Tox. 4; Skin Corr. 1B
3-aminobenzene sulphonic acid; metanilic acid
204-473-6
121-47-1
Acute Tox. 4
3-amino-9-ethyl carbazole; 9-ethylcarbazol-3-ylamine
205-057-7
132-32-1
Carc. 1B
3-amino-4-hydroxy-N-(3-isopropoxypropyl)benzenesulfonamide hydrochloride
427-780-9
114565-70-7
Acute Tox. 4; Eye Dam. 1
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-acetyl-6-methyl-2H-pyran-2,4(3H)-dione; dehydracetic acid
208-293-9
520-45-6
Acute Tox. 4
3-acetyl-1-phenyl-pyrrolidine-2,4-dione
ADDITIVE F6
421-600-2
719-86-8
STOT RE 2
3-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-(E)-2-propenal
425-370-4
93957-50-7
Skin Sens. 1
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-(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-(hydroxyphenylphosphinyl)propanoic acid
FYROL 3-HPP; HIRETAR-205; PHOSGARD PF 100
411-200-6
14657-64-8
Eye Dam. 1
3-(dimethylamino)propylurea
3-(DIMETHYLAMINO)PROPYL UREA; HST 2844
401-950-2
31506-43-1
Eye Dam. 1
3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide; fluxapyroxad
620-041-3
907204-31-3
Lact.
3-(cis-3-hexenyloxy)propanenitril
PARMANYL
415-220-6
142653-61-0
Acute Tox. 3; Acute Tox. 4
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-(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-(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-(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-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
257-187-9
51414-25-6
Skin Sens. 1A
3-(4-fluorophenyl)-2-methylpropionylchloride
426-370-7
1017183-70-8
Skin Corr. 1A; Acute Tox. 4
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-aminophenyl)-2-cyano-2-propenoic acid
AMPCPA
417-480-6
252977-62-1
Skin Sens. 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-(3-methylpent-3-yl)isoxazol-5- ylamine
128719
401-460-9
82560-06-3
Acute Tox. 3; Eye Dam. 1
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-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-(2H-tetrazol-5-yl)pyridine
5-(3-PYRIDYL)-TETRAZOL
426-810-8
3250-74-6
Eye Dam. 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-(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-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-(diaminomethyleneamino)thiazol-4-ylmethylthio)propionitrile
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 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'-phenoxyethoxy)propylamine
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
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