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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 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
(1R,3E,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
95342-41-9
yes
(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
(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,3Z,4R)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
-
852541-25-4
yes
(2R)-3-(4-tert-Butylphenyl)-2-methylpropanal
-
75166-31-3
yes
(2S)-3-(4-tert-Butylphenyl)-2-methylpropanal
-
75166-30-2
yes
(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one
701-394-3
1782069-81-1
yes
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one
253-242-6
36861-47-9
yes
1,2,3-trichloropropane
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
1,2,5,6,9,10-hexabromocyclododecane
221-695-9
3194-55-6
Repr. 2; Lact.
yes
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters
271-094-0
68515-51-5
yes
1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear
271-093-5
68515-50-4
Repr. 1B
yes
1,2-benzenedicarboxylic acid, dipentylester, branched and linear
284-032-2
84777-06-0
Repr. 1B
yes
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters
272-013-1
68648-93-1
yes
1,2-benzenedicarboxylic acid; di-C6-8-branched alkylesters, C7-rich
276-158-1
71888-89-6
Repr. 1B
yes
1,2-benzenedicarboxylic acid; di-C7-11-branched and linear alkylesters
271-084-6
68515-42-4
Repr. 1B
yes
1,2-bis(2-methoxyethoxy)ethane; TEGDME; triethylene glycol dimethyl ether; triglyme
203-977-3
112-49-2
Repr. 1B
yes
1,2-dichloroethane; ethylene dichloride
203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
1,2-diethoxyethane
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
1,2-dimethoxyethane; ethylene glycol dimethyl ether; EGDME
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes
1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione; TGIC
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
1,3,5-tris-[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
1,3-propanesultone; 1,2-oxathiolane 2,2-dioxide
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
1,4-dioxane
204-661-8
123-91-1
Flam. Liq. 2; Carc. 1B; Eye Irrit. 2; STOT SE 3
yes
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
236-948-9
13560-89-9
yes
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 (''Dechlorane Plus''™) including any of its individual anti- and syn-isomers or any combination thereof
-
-
yes
1,7,7-Trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one; 3-Benzylidene camphor
239-139-9
15087-24-8
yes
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-vinylimidazole
214-012-0
1072-63-5
Repr. 1B
yes
2,2'-dichloro-4,4'-methylenedianiline; 4,4'-methylene bis(2-chloroaniline)
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
2,2-bis(bromomethyl)propane-1,3-diol
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
yes
2,2-dimethylpropan-1-ol, tribromo derivative (TBNPA)
253-057-0
36483-57-5
yes
2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid
236-236-8
13252-13-6
yes
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionyl fluoride
218-173-8
2062-98-8
yes
2,3-dibromopropan-1-ol; 2,3-dibromo-1-propanol
202-480-9
96-13-9
Carc. 1B; Repr. 2; Acute Tox. 3; Acute Tox. 4
yes
2,4-Di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol; UV-327
223-383-8
3864-99-1
yes
2,4-dinitrotoluene
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol; UV-328
247-384-8
25973-55-1
yes
2-(2H-Benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol; UV-350
253-037-1
36437-37-3
yes
2-(4-tert-butylbenzyl)propionaldehyde
201-289-8
80-54-6
Repr. 1B
yes
2-(4-tert-Butylbenzyl)propionaldehyde and its individual stereoisomers
show/hide
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
799-970-2
-
yes
2-[2-(4-nonylphenoxy)ethoxy]ethanol
243-816-4
20427-84-3
yes
2-[2-[2-[2-(4-nonylphenoxy)ethoxy]ethoxy]ethoxy]ethanol
230-770-5
7311-27-5
yes
2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethanol
618-344-0
9002-93-1
yes
2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethanol
687-832-3
1119449-37-4
yes
2-Benzotriazol-2-yl-4,6-di-tert-butylphenol; UV-320
223-346-6
3846-71-7
yes
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
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