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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 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
1-(4-(trans-4-pentylcyclohexyl)phenyl)ethanone
4'-(4-PENTYLCYCLOHEXYL)ACETOPHENONE
426-830-7
78531-59-6
Skin Sens. 1
1-(chlorophenylmethyl)-2-methylbenzene
431-450-1
41870-52-4
Skin Irrit. 2
1-(mercaptomethyl)cyclopropylacetic acid
420-240-3
162515-68-6
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
1-(N,N-dimethylcarbamoyl)-3-tert-butyl-5-carbethoxymethylthio-1H-1,2,4-triazole
TRIAZAMATE
411-650-3
110895-43-7
Acute Tox. 3
1-(p-methoxyphenyl)acetaldehyde oxime
MIXOFAM
411-510-1
3353-51-3
Skin Sens. 1
1-[3-[(dimethylamino)methyl]-4-hydroxyphenyl]ethanone
430-920-1
73096-98-7
Acute Tox. 4; Eye Dam. 1
1-[3-[4-((heptadecafluorononyl)oxy)-benzamido]propyl]-N, N,N-trimethylammonium iodide
FT-310; PF-310
407-400-8
59493-72-0
Eye Dam. 1
1-[4-(4-benzoylphenylsulfanyl)phenyl]-2-methyl-2-(4-methylphenylsulfonyl)propan-1-one
429-040-0
272460-97-6
Eye Dam. 1
1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine
SANDUVOR 3058; SANDUVOR 3058 LIQ.
411-930-5
106917-31-1
Skin Irrit. 2; Skin Sens. 1
1-allyl-3-chloro-4-fluorobenzene
CFA; HOE 108219
406-630-6
121626-73-1
Skin Irrit. 2
1-amino-1-cyanamino-2,2-dicyanoethylene, sodium salt
425-870-2
19450-38-5
Skin Sens. 1
1-amino-2-methyl-2-propanethiol hydrochloride
434-480-1
32047-53-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
1-amino-4-(3-[4-chloro-6-(2,5-di-sulfophenylamino)-1,3,5-triazin-2-ylamino]-2,2-dimethyl-propylamino)-anthraquinone-2-sulfonic acid, sodium/lithium salt
BLAU MUB 557
419-520-8
172890-93-6
Skin Sens. 1
1-amino-4-[(4-amino-2-sulfofenyl)amino]-9,10-dihydro-9,10-dioxo-2-anthracenesulfonic acid, disodium salt, reaction products with 2-[[3-[(4,6-dichloro-1,3,5-triazin-2-yl)ethylamino]phenyl]sulfonyl]ethyl hydrogen sulfate, sodium salts
451-430-4
500717-36-2
Eye Dam. 1; Skin Sens. 1
1-aminocyclopentanecarboxamide
422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
1-aminopropan-2-ol; isopropanolamine
201-162-7
78-96-6
Skin Corr. 1B
1-benzyl-5-ethoxyimidazolidine-2,4-dione
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
1-benzylimidazolidine-2,4-dione
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
1-bromo-2-methylpropyl propionate
422-900-6
158894-67-8
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Skin Sens. 1
1-bromo-3,4,5-trifluorobenzene
1-BROM-3,4,5-TRIFLUORBENZOL; 1-BROMO-3,4,5-TRIFLUOROBENZENE
418-480-9
138526-69-9
Flam. Liq. 3; Carc. 2; Skin Irrit. 2; Eye Dam. 1
1-bromo-3,5-difluorobenzene
1-BROM-3,5-DIFLUORBENZOL; 1-BROMO-3,5-DIFLUOROBENZENE; BDFB
416-710-2
461-96-1
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
1-bromo-9-(4,4,5,5,5-pentafluoropentylthio)nonane
BROMIDE 182,780
422-850-5
148757-89-5
Skin Sens. 1
1-bromopropane; n-propyl bromide
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
1-butyl-2-methylpyridinium bromide
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
1-chloro-1-nitropropane
209-990-0
600-25-9
Acute Tox. 4
1-chloro-2,3-epoxypropane; epichlorhydrin
203-439-8
106-89-8
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
1-chloro-4-nitrobenzene
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine
GM 102 E
411-370-1
82857-68-9
Acute Tox. 3; Eye Dam. 1
1-chlorobutane; butyl chloride
203-696-6
109-69-3
Flam. Liq. 2
1-chloromethyl-4-fluoro-1,4-diazoniabicyclo[2.2.2]octane bis(tetrafluoroborate)
414-380-4
140681-55-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1-chloropentane
208-846-4
543-59-9
Flam. Liq. 2; Acute Tox. 4
1-chloropropane
208-749-7
540-54-5
Flam. Liq. 2; Acute Tox. 4
1-cyclopropyl-3-(2-methylthio-4-trifluoromethylphenyl)-1,3-propanedione
421-080-7
161462-35-7
STOT RE 2
1-cyclopropyl-6,7-difluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
CHINOLONCARBONSÄURE 93-073; CP-70,335
413-760-7
93107-30-3
Repr. 2
1-dimethoxymethyl-2-nitro-benzene
O-NITROBENZALDEHYDDIMETHYLACETAL
423-830-9
20627-73-0
Skin Sens. 1
1-dimethylaminopropan-2-ol; dimepranol (INN)
203-556-4
108-16-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
1-dimethylcarbamoyl-4-(2-sulfonatoethyl)pyridinium
418-440-0
136997-71-2
Skin Sens. 1
1-dimethylcarbamoyl-5-methyl pyrazol-3-yl dimethylcarbamate; dimetilan (ISO)
211-420-0
644-64-4
Acute Tox. 3; Acute Tox. 4
1-dodecyl-2-pyrrolidone
SURFADONE LP-300 SURFACTANT
403-730-1
2687-96-9
Skin Corr. 1B; Skin Sens. 1
1-ethoxy-2,3-difluorobenzene
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
1-ethoxypropan-2-ol; 2PG1EE; 1-ethoxy-2-propanol; propylene glycol monoethyl ether
216-374-5
1569-02-4
Flam. Liq. 3; STOT SE 3
1-ethyl-1-methylmorpholinium bromide
MEM
418-250-8
65756-41-4
Muta. 2
1-ethyl-1-methylpyrrolidinium bromide
MEP
418-200-5
69227-51-6
Muta. 2
1-ethyl-5,6,7,8-tetrahydroquinolinium tosylate
419-570-0
195006-58-7
Acute Tox. 4
1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [> 91 % solution];1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [≤ 91 % solution]
201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [> 91 % solution];1-hydroperoxycyclohexyl 1-hydroxycyclohexyl peroxide [≤ 91 % solution]
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
1-hydroxy-4-fluoro-1,4-diazoniabicyclo[2.2.2]octane bis(tetrafluoroborate)
418-330-2
162241-33-0
Expl. 1.1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
1-hydroxybenzotriazole, anhydrous
219-989-7
2592-95-2
Expl. 1.3
1-hydroxybenzotriazole, monohydrated
602-929-2
123333-53-9
Expl. 1.3
1-imidazol-1-yl-octadecan-2-ol
434-120-3
1380001-48-8
Skin Sens. 1
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