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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 aprile 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
'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,3E,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
95342-41-9
yes
(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,3Z,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
852541-21-0
yes
(1R,4S)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
741687-98-9
yes
(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,2S,5R,6R,9S,10S,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene
-
135821-03-3
yes
(1S,2S,5S,6S,9R,10R,13R,14R)-1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.1⁶,⁹.0²,¹³.0⁵,¹⁰]octadeca-7,15-diene
-
135821-74-8
yes
(1S,3E,4R)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
852541-30-1
yes
(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,3Z,4R)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
852541-25-4
yes
(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
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