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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 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
1,3-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
1,6-hexanediammonium, sodium 5-sulfato-1,3-benzenedicarboxylate
425-730-0
51178-75-7
Skin Sens. 1
1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate
HÄRTER VERSUCHSPRODUKT LS 2959E; HÄRTER VP LS 2959E
411-700-4
140921-24-0
Skin Sens. 1
1,7,7-Trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one; 3-Benzylidene camphor
239-139-9
15087-24-8
yes
1,7,7-trimethylbicyclo(2,2,1)hept-2-yl thiocyanatoacetate; isobornyl thiocyanoacetate
204-081-5
115-31-1
Acute Tox. 4
1-((2-quinolinyl-carbonyl)oxy)-2,5-pyrrolidinedione
PTH-SUCCINIMIDESTER
418-630-3
136465-99-1
Eye Dam. 1; Skin Sens. 1
1-(1,4-benzodioxan-2-ylcarbonyl)piperazine hydrochloride
DOXAZOSIN 4; DOXAZOSIN STEP 4
415-660-9
70918-74-0
Acute Tox. 3; STOT RE 2
1-(1-naphthylmethyl)quinolinium chloride
CIB R634
406-220-7
65322-65-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
1-(2,3-dihydro-1,3,3,6-tetramethyl-1-(1-methylethyl)-1H-inden-5-yl)ethanone
ACYLINDANE
411-180-9
92836-10-7
Acute Tox. 4; STOT RE 2
1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethanone methanesulfonate
431-010-7
154486-26-7
Acute Tox. 4; Eye Dam. 1
1-(2-(ethyl(4-(4-(4-(4-(ethyl(2-pyridinoethyl)amino)-2-methylphenylazo)benzoylamino)-phenylazo)-3-methylphenyl)amino)ethyl)-pyridinium dichloride
ORANGE DK 2764
420-950-3
163831-67-2
Eye Dam. 1
1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing < 0,1 % 4-chloroaniline (EC No 203-401-0)];1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing ≥ 0,1 % 4-chloroaniline (EC No 203-401-0)]
433-580-2
214353-17-0
Carc. 1B; Acute Tox. 4; Skin Corr. 1B
1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing < 0,1 % 4-chloroaniline (EC No 203-401-0)];1-(2-amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride [containing ≥ 0,1 % 4-chloroaniline (EC No 203-401-0)]
433-580-2
214353-17-0
Acute Tox. 4; Skin Corr. 1B
1-(2-butoxypropoxy)propan-2-ol
246-011-6
24083-03-2
Acute Tox. 4
1-(2-chlorophenyl)-1,2-dihydro-5H-tetrazol-5-one
426-110-2
98377-35-6
Skin Sens. 1
1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
PYRAZOL P5; PYRAZOLE DHE
429-300-3
155601-30-2
Eye Dam. 1; Skin Sens. 1
1-(2-propenyl)pyridinium chloride
GOLPANOL APC
412-740-5
25965-81-5
Acute Tox. 4; Skin Sens. 1
1-(3,4-dichlorophenylimino); thiosemicarbazide
-
5836-73-7
Acute Tox. 2
1-(3-(4-fluorophenoxy)propyl)3-methoxy-4-piperidinone
T1314
411-500-7
116256-11-2
Acute Tox. 4; 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
1-(3-iodo-4-aminobenzyl)-1H-1,2,4-triazole
IODOANILINE TRIAZOLE
419-540-7
160194-26-3
Acute Tox. 4; Skin Sens. 1
1-(3-methoxypropyl)-4-piperidinamine
431-950-8
179474-79-4
Acute Tox. 4; Skin Corr. 1B
1-(3-phenylpropyl)-2-methylpyridinium bromide
NT-8
405-930-4
10551-42-5
Acute Tox. 4; Eye Irrit. 2
1-(4-(trans-4-butylcyclohexyl)phenyl)ethanone
4-(4-BUTYLCYCLOHEXYL)-ACETOPHENON
427-320-7
83626-30-6
Skin Sens. 1
1-(4-(trans-4-ethylcyclohexyl)phenyl)ethanone
4-(4-ETHYLCYCLOHEXYL)-ACETOPHENON
426-460-6
260415-81-4
Skin Sens. 1
1-(4-(trans-4-heptylcyclohexyl)phenyl) ethanone
4'-(4-HEPTYLCYCLOHEXYL)ACETOPHENONE
426-820-2
78531-60-9
Skin Sens. 1
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