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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 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
1,2-dimethylhydrazine
-
540-73-8
Carc. 1B; Acute Tox. 3
1,2-dimethylimidazole
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
1,2-dinitrobenzene
208-431-8
528-29-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,2-epoxybutane
203-438-2
106-88-7
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
1,3,5-trinitrobenzene
202-752-7
99-35-4
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,3,5-trioxan; trioxymethylene
203-812-5
110-88-3
Flam. Sol. 1; Repr. 2; STOT SE 3
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-bis(2,3-epoxypropoxy)-2,2-dimethylpropane
241-536-7
17557-23-2
Skin Irrit. 2; Skin Sens. 1
1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
PERKALINK 900
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
1,3-bis(dimethylcarbamoyl)-imidazolium chloride
420-930-4
135756-61-5
Acute Tox. 4; Eye Dam. 1
1,3-bis(vinylsulfonylacetamido)propane
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
1,3-bis[12-hydroxy-octadecamide-N-methylene]-benzene
423-300-7
911674-82-3
Skin Sens. 1
1,3-bis{6-fluoro-4-[1,5-disulfo-4-(3-aminocarbonyl-1-ethyl-6-hydroxy-4-methyl-pyrid-2-on-5-ylazo)-phenyl-2-ylamino]-1,3,5-triazin-2-ylamino}propane lithium-, sodium salt
JAUNE REACTIF MUB 151
415-100-3
149850-29-3
Skin Sens. 1
1,3-butadiene; buta-1,3-diene
203-450-8
106-99-0
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
1,3-di(prop-2,2-diyl)benzene bis(neodecanoylperoxide)
DIPND-50-AL (META)
420-060-5
117663-11-3
Flam. Liq. 3; Org. Perox. D
1,3-dichlorbenzene
208-792-1
541-73-1
Acute Tox. 4
1,3-dichloro-2-propanol
202-491-9
96-23-1
Carc. 1B; Acute Tox. 3; Acute Tox. 4
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
1,3-dichloro-5-ethyl-5-methylimidazolidine-2,4-dione
DCEMH
401-570-7
89415-87-2
Ox. Sol. 1; Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
1,3-dichloropropene
208-826-5
542-75-6
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
1,3-diethoxypropane
DE 3
413-140-6
3459-83-4
Flam. Liq. 3
1,3-dimethyl-1,3-bis(trimethylsilyl)urea
UTMS
414-180-7
10218-17-4
Acute Tox. 4; Skin Irrit. 2
1,3-dinitrobenzene
202-776-8
99-65-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,3-dioxolane
211-463-5
646-06-0
Flam. Liq. 2
1,3-diphenylguanidine
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,3-propanesultone; 1,2-oxathiolane 2,2-dioxide
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes
1,3-propylene oxide
207-964-3
503-30-0
Flam. Liq. 2; Acute Tox. 4
1,4,5,6,7,7-hexachlorobicyclo [2,2,1]hept-5-ene-2,3-dicarboxylicanhydride chlorendic anhydride
204-077-3
115-27-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,4,5,8-tetraaminoanthra; quinone; C.I. Disperse Blue 1
219-603-7
2475-45-8
Carc. 1B; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1,4,7,10-tetraazacyclododecane
425-450-9
294-90-6
Skin Corr. 1B; Acute Tox. 4
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
1,4,7,10-tetrakis(p-toluensulfonyl)-1,4,7,10-tetraazacyclododecane
AZA-KRONE-TETRATOSYLAT
414-030-0
52667-88-6
Skin Sens. 1
1,4-bis(2,3 epoxypropoxy)butane; butanedioldiglycidyl ether
219-371-7
2425-79-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
1,4-bis[(vinyloxy)methyl]cyclohexane
RAPICURE CHVE
413-370-7
17351-75-6
Skin Sens. 1
1,4-dichloro-2-(1,1,2,3,3,3-hexafluoropropoxy)-5-nitrobenzene
CA 946 A
415-580-4
130841-23-5
Acute Tox. 4; Skin Sens. 1
1,4-dichlorobenzene; p-dichlorobenzene
203-400-5
106-46-7
Carc. 2; Eye Irrit. 2
1,4-dichlorobut-2-ene
212-121-8
764-41-0
Carc. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
1,4-Dicyano-2,3,5,6-tetra-chloro-benzene
TETRACHLOROTEREPHTHALONITRILE
401-550-8
1897-41-2
Skin Sens. 1
1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate
429-370-5
220410-74-2
Acute Tox. 4
1,4-dihydroxybenzene; hydroquinone; quinol
204-617-8
123-31-9
Carc. 2; Muta. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1,4-dimethylcyclohexane
209-663-2
589-90-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
1,4-dimethylnaphthalene
209-335-9
571-58-4
Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2
1,4-dinitrobenzene
202-833-7
100-25-4
Acute Tox. 2; Acute Tox. 1; STOT RE 2
1,4-dioxane
204-661-8
123-91-1
Flam. Liq. 2; Carc. 1B; Eye Irrit. 2; STOT SE 3
yes
1,5-naphthylene diisocyanate
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
1,5-naphthylenediamine
218-817-8
2243-62-1
Carc. 2
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
1,6-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
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