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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 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-propanolide;1,3-propiolactone
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; 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
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
4'-ethoxy-2-benzimidazoleanilide
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
4'-fluoro-2,2-dimethoxyacetophenone
DMA
407-500-1
21983-80-2
Skin Sens. 1
4,4'-(1,3-phenylene-bis(1-methylethylidene))bis-phenol
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
4,4'-(1-Methylpropylidene)bisphenol
201-025-1
77-40-7
yes
4,4'-(4-iminocyclohexa-2,5-dienylidenemethylene)dianiline hydrochloride; C.I. Basic Red 9
209-321-2
569-61-9
Carc. 1B
4,4'-(oxy-(bismethylene))-bis-1,3-dioxolane
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
4,4'-bi-o-toluidine
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol
209-218-2
561-41-1
yes
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(N-carbamoyl-4-methylbenzenesulfonamide)diphenylmethane
B-TUM
418-770-5
151882-81-4
Carc. 2
4,4'-carbonimidoylbis[N, N-dimethylaniline]
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
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'-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'-ethylidenediphenyl dicyanate
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; Eye Dam. 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'-methylenebis(2,6-dimethylphenyl cyanate)
AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
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-isopropyl-6-methylaniline)
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
4,4'-methylenebis(N,N'-dimethylcyclohexanamine)
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
4,4'-methylenedi(cyclohexyl isocyanate); dicyclohexylmethane-4,4'-di-isocyanate
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4,4'-methylenedi-o-toluidine
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
4,4'-methylenediphenyl diisocyanate; diphenylmethane-4,4'-diisocyanate
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4,4'-oxybis(benzenesulfonylazide)
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
4,4'-oxybis(ethylenethio)diphenol
DD-63
404-590-4
90884-29-0
Skin Sens. 1
4,4'-oxydianiline and its salts; p-aminophenyl ether
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
4,4'-oxydianiline and its salts; p-aminophenyl ether
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
4,4'-thiodi-o-cresol
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
4,4'-thiodianiline and its salts
-
-
Carc. 1B; Acute Tox. 4
4,4'-thiodianiline and its salts
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
4,4,5,5,5-pentafluoropentan-1-ol
421-360-9
148043-73-6
Acute Tox. 4
4,4,5,5-tetrachloro-1,3-dioxolan-2-one
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
4,4-dimethoxybutylamine
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
4,4-isobutylethylidenediphenol
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
4,5-dichloro-2-octyl-2H-isothiazol-3-one; [DCOIT]
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
4,8,12-trimethyltrideca-3,7,11-trienoic acid, mixed isomers
HOMOFARNESYLSÄURE
403-000-2
91853-67-7
Skin Irrit. 2
4-(1(or 4 or 5 or 6)-methyl-8,9,10-trinorborn-5-en-2- yl)pyridine, reaction mass of isomers
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
-
-
yes
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
621-341-7
2315-61-9
yes
4-(1,1,3,3-tetramethylbutyl)phenol; 4-tert-octylphenol
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
4-(1,4-dioxa-spiro[4.5]dec-8-yl)-cyclohexanone
423-860-2
56309-94-5
Skin Sens. 1
4-(1-ethyl-1-methylhexyl)phenol
257-907-1
52427-13-1
yes
4-(1-oxo-2-propenyl)-morpholine
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-(2,6-dimethylheptan-2-yl)phenol
635-388-6
521947-27-3
yes
4-(2-chloro-4-trifluoromethyl)phenoxy-2-fluoroaniline hydrochloride
WL 125892
402-190-4
113674-95-6
STOT RE 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-(2-cyano-3-phenylamino acryloyloxymethyl)-cyclohexyl-methyl 2-cyano-3-phenylamino)-acrylate
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
4-(2-methylacryloyloxy)phenyl4-allyloxybenzoate
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1
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