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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 10 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
tetraammine palladium (II)hydrogen carbonate
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2,4-diamino-3,5-diethyltoluene; 2,4-diethyl-6-methyl-1,3-benzenediamine
218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,4-diamino-5-methoxymethylpyrimidine
DAMP
410-330-0
54236-98-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,6-diamino-3,5-diethyltoluene; 4,6-diethyl-2-methyl-1,3-benzenediamine
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
diethylmethylbenzenediamine
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
N-carboxymethyliminobis(ethylenenitrilo)tetra (acetic acid)
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
pentapotassium 2,2',2'',2''',2''''-(ethane-1,2-diylnitrilo)pentaacetate
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
thiram (ISO); tetramethylthiuram disulphide
205-286-2
137-26-8
Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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
hydroxydisulfito platinum(II)acid
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
1,1,3,3-tetrabutyl-1,3-ditinoxydicaprylate
D 28-283
419-430-9
56533-00-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
reaction mass of: dodecyl N-(2,2,6,6-tetramethylpiperidin-4-yl)-β-alaninate; tetradecyl N-(2,2,6,6-tetramethylpiperidin-4-yl)-β-alaninate
VP SANDUVOR 3052 LIQUIDE
405-670-1
119530-69-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
1,6-bis(3,3-bis((1-methylpentylidenimino)propyl)ureido)hexane
SETALUX EPC 4690
420-190-2
771478-66-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-bromo-1-(2-furyl)-2-nitroethylene
EF-40
406-110-9
35950-52-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-butyl-2-ethyl-1,5-diaminopentane
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
hydroxyphosphonoacetic acid
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
tributyltetradecylphosphonium tetrafluoroborate
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
1,3-dichloro-4-fluorobenzene
1,3-DICHLOR-4-FLUORBENZOL; B-7
406-160-1
1435-48-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
2-(4-(4-cyano-3-methylisothiazol-5-ylazo)-N-ethyl-3-methylanilino)ethyl acetate
TTP MAGENTA 3
405-480-9
110260-50-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
2,2'-iminodiethanol; diethanolamine
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2,3,4-trifluoroaniline
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-(2-(2-hydroxyethoxy)ethyl)-2-aza-bicyclo[2.2.1]heptane
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
4-[3-(diethoxymethylsilylpropoxy)-2,2,6,6-tetramethyl]piperidine
PSL 6
411-400-3
102089-33-8
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-chloromethyl-3,4-dimethoxypyridinium chloride
B8510-020; CHLORMETHYLPYRIDIN; CHLORMETHYLPYRIDINE; CHLOROMETHYLPYRIDINE
416-440-5
72830-09-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
3-(2-bromopropionoyl)-4,4-dimethyl-1,3-oxazolan-2-one
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
tetrabutylammonium 2-amino-6-iodopurinate
424-710-9
156126-48-6
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1-(3-cyclopentyloxy-4-methoxyphenyl)-4-oxo-cyclohexanecarbonitrile
427-450-4
152630-47-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
2,3-dihydro-2,2-dimethyl-1H-perimidine
424-060-6
6364-17-6
Acute Tox. 4; STOT RE 2; Skin Sens. 1
3-cyano-3,5,5-trimethylcyclohexanone
ISOPHORONENITRILE, IPN
411-490-4
7027-11-4
Acute Tox. 4; STOT RE 2; Skin Sens. 1
amitraz (ISO); N,N-bis(2,4-xylyliminomethyl); methylamine
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
bis(4-hydroxy-N-methylanilinium) sulphate
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
clodinafop-propargyl (ISO)
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1
diethyl thiophosphoryl (Z)-(2-aminothiazol-4-yl)methoxyimino acetate
DAMA
426-790-0
162208-27-7
Acute Tox. 4; STOT RE 2; Skin Sens. 1
disulfiram; tetraethylthiuramdisulfide
202-607-8
97-77-8
Acute Tox. 4; STOT RE 2; Skin Sens. 1
flufenacet (ISO);N-(4-fluorophenyl)-N-isopropyl-2-(5-trifluoromethyl-[1,3,4]thiadiazol-2-yloxy)acetamide
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
propineb (ISO); polymeric zinc propylenebis(dithiocarbamate)
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
tri-allate (ISO); S-2,3,3-trichloroallyl diisopropylthiocarbamate
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate; epsilon-momfluorothrin
-
1065124-65-3
Acute Tox. 4; STOT SE 2
methyl 2,5-dichlorobenzoate
220-815-7
2905-69-3
Acute Tox. 4; STOT SE 3
1,4,7,10-tetraazacyclododecane disulfate
AZA-KRONE-DISULFAT; SQ 84,042F
412-080-8
112193-77-8
Acute Tox. 4; STOT SE 3; Eye Dam. 1
2-phenoxyethanol
204-589-7
122-99-6
Acute Tox. 4; STOT SE 3; Eye Dam. 1
4-methyl-N-(methylsulfonyl)benzenesulfonamide
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
calcium cyanamide
205-861-8
156-62-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1
2,4-D (ISO); 2,4-dichlorophenoxyacetic acid
202-361-1
94-75-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1; Skin Sens. 1
cypermethrin (ISO); α-cyano-3-phenoxybenzyl 3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate; cypermethrin cis/trans +/- 40/60;cypermethrin cis/trans +/-80/20; (RS)-α-cyano-3-phenoxybenzyl (1RS;3RS; 1RS, 3SR)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; STOT RE 2
hexamethylenediamine
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
cyclohexanol
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
1-naphtol
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
bronopol (INN); 2-bromo-2-nitropropane-1,3-diol
200-143-0
52-51-7
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
sodium 2-biphenylate; 2-phenylphenol, sodium salt
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
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