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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
6-phenyl-1,3,5-triazine-2,4- diyldiamine; 6-phenyl-1,3,5-triazine-2,4-diamine; benzoguanamine
202-095-6
91-76-9
Acute Tox. 4
7,7-dimethyl-3-oxa-6-azaoctan-1-ol
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
7-[((4,6-dichloro-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-(4-((2-sulfoxy)ethyl)sulfonyl)phenylazo]naphthalene-2-sulfonic acid
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
7-amino-3-((5-carboxymethyl-4- methyl-1,3-thiazol-2- ylthio)methyl)-8-oxo-5-thia-1- azabicyclo(4.2.0)oct-2-ene-2- carboxylic acid
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
7-amino-4-hydroxy-2-naphthalenesulfonic acid, coupled with 5 (or 8) -amino-8 (or 5)-[[4-[[4-[[4-amino-6(or 7)-sulfo-1-naphthyl]azo]phenyl]amino]-3-sulfophenyl]azo]-2-naphthalenesulfonic acid and 4-hydroxy-7-(phenylamino)-2-naphthalenesulfonic acid, sodium salt
424-850-0
189702-72-5
Eye Dam. 1
7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
7-methoxy-6-(3-morpholin-4-yl-propoxy)-3H-quinazolin-4-one [containing ≥ 0,5 % formamide (EC No 200-842-0)]
429-400-7
199327-61-2
Repr. 1B
7-methylocta-1,6-diene
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
7-oxa-3-oxiranylbicyclo [4.1.0]heptane; 1,2-epoxy- 4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
7a-ethyl-3,5-bis(1-methylethyl)-2,3,4,5-tetrahydrooxazolo[3,4-c]-2,3,4,5-tetrahydrooxazole
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
8,8-dimethyl-7-isopropyl-6,10-dioxaspiro[4.5]decane
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
8,9,10-trinorborn-2-yl acrylate
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
8,9-dinorborn-5-ene-2,3-dicarboxylic anhydride
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
8-amino-7-methylquinoline
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
8-azaspiro[4.5]decane-7,9-dione
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
8-p-menthyl hydroperoxide; p-menthane hydroperoxide
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
9,9-bis(4-hydroxyphenyl)fluorene
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
9-(2-propenyloxy)tricyclo[5.2.1.0(2,6)]dec-3(or-4-)-ene
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
9-vinylcarbazole
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
[(1-methyl-1,2-ethanediyl)bis[nitrilobis(methylene)]]tetrakis(phosphonic acid)
421-940-1
28698-31-9
Eye Dam. 1
[(4S, 5S)-4-benzyl-2-oxo-5-oxazolidinyl]methyl 4-nitrobenzenesulfonate
416-360-0
162221-28-5
Skin Sens. 1
[(dimethylsilylene)bis((1,2,3,3a,7a-η)-1H-inden-1-ylidene)dimethyl]hafnium
M1
422-060-0
137390-08-0
Acute Tox. 2
[(m-tolyloxy)methyl]oxirane
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[(p-tolyloxy)methyl]oxirane
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[(tolyloxy)methyl]oxirane; cresyl glycidyl ether
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[1R-(1-α, 2β,5α)]-mono[5-methyl-2-(1-methylethyl)cyclohexyl]butanedioate
426-890-4
77341-67-4
Eye Dam. 1
[2-[(4-nitrophenyl)amino]ethyl]urea
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
[3-(chlorocarbonyl)-2-methylphenyl]acetate
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride; C.I. Basic Blue 26
219-943-6
2580-56-5
yes
[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl] acetic acid
419-270-1
123599-82-6
Eye Irrit. 2
[carbonato(2-)] tetrahydroxytrinickel
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
[N-(1,1-dimethylethyl)-1,1-dimethyl-1-[(1,2,3,4,5-η)-2,3,4,5-tetramethyl-2,4-cyclopentadien-1-yl]silanaminato(2-)-κN][(1,2,3,4-η)-1,3-pentadiene]-titanium
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
[phosphinyldynetris(oxy)] tris[3-aminopropyl-2-hydroxy-N, N-dimethyl-N-(C6-18)-alkyl] trichlorides
425-520-9
197179-61-6
Eye Dam. 1
[Phthalato(2-)]dioxotrilead
273-688-5
69011-06-9
yes
[R-(R*,S*)]-[[2-methyl-1-(1-oxopropoxy)propoxy]-(4-phenylbutyl)phosphinyl] acetic acid, (-)-cinchonidine (1:1) salt
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
[μ-[carbonato(2-)-O:O']]dihydroxy trinickel
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
A reaction mass of: (1,3-dioxo-2H-benz(de)isoquinolin-2-ylpropyl)hexadecyldimethylammonium 4-toluenesulfonate; (1,3-dioxo-2H-benz(de)isoquinolin-2-ylpropyl)hexadecyldimethylammonium bromide
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
abamectin (combination of avermectin B1a and avermectin B1b) (ISO)
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
Absettarov
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Absorption oils, bicyclo arom. and heterocyclic hydrocarbon fraction; Wash Oil Redistillate [A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260 °C to 290 °C (500°F to 554°F).]
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
Acanthamoeba castellani
-
-
P Parasites
acephate (ISO); O, S-dimethyl acetylphosphoramidothioate
250-241-2
30560-19-1
Acute Tox. 4
acequinocyl (ISO); 3-dodecyl-1,4-dioxo-1,4-dihydronaphthalen-2-yl acetate
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
acetaldehyde; ethanal
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
acetamide
200-473-5
60-35-5
Carc. 2
acetamiprid (ISO); (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine
603-921-1
135410-20-7
Acute Tox. 4
acetic acid ... %
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
Acetic acid, lead salt, basic
257-175-3
51404-69-4
yes
acetic anhydride
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
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