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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 03 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
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1)
274-462-9
70225-16-0
yes
triethyl arsenate
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
Trilead bis(carbonate)dihydroxide
215-290-6
1319-46-6
yes
Trilead diarsenate
222-979-5
3687-31-8
yes
Trilead dioxide phosphonate
235-252-2
12141-20-7
yes
tris(2-chloroethyl)phosphate
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane
213-934-0
1067-53-4
Repr. 1B
yes
Tris(4-nonylphenyl, branched) phosphite
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Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
799-976-5
-
yes
tris(nonylphenyl) phosphite
247-759-6
26523-78-4
Skin Sens. 1
yes
Trisodium orthoborate
238-253-6
14312-40-4
yes
trixylyl phosphate
246-677-8
25155-23-1
Repr. 1B
yes
Zirconia Aluminosilicate Refractory Ceramic Fibres
936-037-2
-
yes
α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol; C.I. Solvent Blue 4
229-851-8
6786-83-0
yes
'amyl nitrite', mixed isomers
203-770-8
110-46-3
Flam. Liq. 2; Acute Tox. 4
((4-phenylbutyl)hydroxyphosphoryl)acetic acid
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
(+)-(1S, 2S, 3S, 5R)-2,6,6-trimethylbicyclo[3.1.1]heptane-3-spiro-1'-(cyclohex-2'-en-4'-one)
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
(+/-)-(R*,R*)-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran; 6-fluoro-2-(2-oxiranyl)chromane
419-620-1
-
Skin Sens. 1
(-)(3S, 4R)-4-(4-fluorophenyl)-3-(3,4-methylenedioxy-phenoxymethyl)-N-benzylpiperidine hydrochloride
432-360-3
105813-13-6
Acute Tox. 4; Skin Sens. 1
(-)-trans-4-(4'-fluorophenyl)-3-hydroxymethyl-N-methylpiperidine
BRL 29226
406-030-4
105812-81-5
Acute Tox. 4; Eye Dam. 1
(1,3,4,5,6,7-hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
(1-hydroxydodecylidene)diphosphonic acid
KELCOR; LIPOKEL; SEQUOL
425-230-2
16610-63-2
Skin Corr. 1B
(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
256-032-2
42978-66-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
(1R, 4R)-4-methoxy-2,2,7,7-tetramethyltricyclo(6.2.1.0(1,6))undec-5-ene
444-480-3
393517-29-8
Skin Irrit. 2
(1R,3S,7R,8R,10R,13R)-5,5,7,9,9,13-hexamethyl-4,6-dioxatetracyclo[6.5.1.01,10.03,7]tetradecane
427-580-1
211299-54-6
Skin Irrit. 2
(1R,4S)-2-azabicyclo[2.2.1]hept-5-en-3-one
1418U90
418-530-1
79200-56-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(1S)-2-methyl-2,5-diazobicyclo[2.2.1]heptanes dihydrobromide
CP-84,203-4; DFX-5S
411-000-9
125224-62-6
Skin Sens. 1
(1S,3S,5R,6R)-(4-nitrophenylmethyl)-1-dioxo-6-phenylacetamido-penam-3-carboxylate
P-NITROBENZYLESTER PGSO
412-670-5
54275-93-3
Resp. Sens. 1
(1S,4R,6R,7R)-(4-nitrophenylmethyl)3-methylene-1-oxo-7-phenylacetamido-cepham-4-carboxylateido-penam-3-carboxylate
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
(1S-cis)-4-(2-amino-6-chloro-9H-purin-9-yl)-2-cyclopentene-1-methanol hydrochloride
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine 2-hydroxy-2-phenylacetate
SERTRALINE STEP 2
420-560-3
79617-97-3
Eye Dam. 1
(1α,2α,3β,6β)-1,2,3,6-tetrahydro-3,6-methanophthalic anhydride
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
(1α5α6α)-6-nitro-3-benzyl-3-azabicyclo[3.1.0]hexane methanesulfonate salt
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1
(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(-3-(diethylammonio)propylamino)1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
BLUE 10 25 964
407-240-9
159604-94-1
Skin Sens. 1
(2,3,5,6-tetrafluorophenyl)methanol
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
(2,3-dimethylbut-2-yl)-trimethoxysilane
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
(2,4-diaminopteridin-6-yl)methanol hydrobromide
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
(2,5-dioxopyrrolidin-1-yl)-9H-fluoren-9-ylmethyl carbonate
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
(2,6-xylyloxy) acetic acid
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
(2-(1,3-dioxolan-2-yl)ethyl)triphenylphosphonium bromide
DWS
404-940-6
86608-70-0
Acute Tox. 4; Eye Dam. 1; STOT RE 2
(2-(aminomethyl)phenyl)acetylchloride hydrochloride
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
(2-butyl-5-nitrobenzofuran-3-yl)[4-(3-dibutylaminopropoxy)phenyl]methanone
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
(2-chloroethyl)(3-hydroxypropyl)ammonium chloride
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
(2-ethylhexanoato-O)(isodecanoato-O)nickel
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(2-ethylhexanoato-O)(isononanoato-O)nickel
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(2-methylpropyl)lithium; isobutyllithium
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
(2R)-2-amino-2-phenylacetamide
420-370-0
6485-67-2
Eye Irrit. 2; Skin Sens. 1
(2R*, 3S*)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (1R)-10-camphorsulfonate
UK-103,449-BV
427-100-0
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
(2R, 3S, 4R, 5R, 7R, 9R, 10R,11S, 12S, 13R)-10-[(4-dimethylamino-3-hydroxy-6-methyltetrahydropyran-2-yl)oxy]-2-ethyl-3,4,12-trihydroxy-9-methoxy-3,5,7,9,11,13-hexamethyl-6,14-dioxo-1-oxacyclotetradecane
433-820-6
118058-74-5
Eye Irrit. 2
(2R,3R)-3-((R)-1-(tert-butyldimethylsiloxy)ethyl)-4-oxoazetidin-2-yl acetate
4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
(2R,3S)-N-(3-amino-2-hydroxy-4-phenylbutyl)-N-isobutyl-4-nitrobenzenesulfonamide hydrochloride
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
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