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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 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-methyltrimethylene diacrylate; 1,3-butylene glycol diacrylate
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
1-naphthylamine
205-138-7
134-32-7
Acute Tox. 4
1-nitropropane
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
1-phenyl-3-(p-toluenesulfonyl)urea
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
1-vinylimidazole
214-012-0
1072-63-5
Repr. 1B
yes
18-methylnonadecyl 2,2-dimethylpropanoate
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
2'-(2-cyano-4,6-dinitrophenylazo)-5'-(N, N-dipropylamino)propionanilide
BLEU DISPERSE 370; BLEU DISPERSO 370; BLEU LIP 6994; C.I. DISPERSE BLUE 370; DISPERS BLAU 370; DISPERSE BLUE 370
403-010-7
106359-94-8
Skin Sens. 1
2'-(4-chloro-3-cyano-5-formyl-2-thienyl)azo-5'-diethylaminoacetanilide
BLEU 1047679; BLUE 1047679
405-200-5
104366-25-8
Skin Sens. 1
2'-(4-chloro-3-cyano-5-formyl-2-thienylazo)-5'-diethylamino-2-methoxyacetanilide
BLEU 1044098; BLUE 1044098
405-190-2
122371-93-1
Skin Sens. 1
2,2' -oxybisethanol; diethylene glycol
203-872-2
111-46-6
Acute Tox. 4
2,2'-(ethylenedioxy)diethyl diacrylate; triethylene glycol diacrylate
216-853-9
1680-21-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2'-(methylimino)diethanol; N-methyldiethanolamine
203-312-7
105-59-9
Eye Irrit. 2
2,2'-(nitrosoimino)bisethanol
214-237-4
1116-54-7
Carc. 1B
2,2'-bioxirane; 1,2:3,4-diepoxybutane
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
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'-iminodiethanol; diethanolamine
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2,2'-iminodiethylamine; diethylenetriamine
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,2'-thiodiethanol; thiodiglycol
203-874-3
111-48-8
Eye Irrit. 2
2,2,4-trimethylhexamethylene-1,6-di-isocyanate
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
2,2,6,6-tetrakis(bromomethyl)-4-oxaheptane-1,7-diol
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
2,2-(1,4-phenylene)bis((4H—3,1-benzoxazine-4-one)
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,2-bis(hydroxymethyl)butanoic acid
DMBA
424-090-1
10097-02-6
Eye Dam. 1
2,2-dibromo- 2-cyanoacetamide; [DBNPA]
233-539-7
10222-01-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2,2-dimethyl 3-methyl-3-butenyl propanoate
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propionic acid
236-236-8
13252-13-6
yes
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
2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
2,3-epoxypropyl acrylate; glycidyl acrylate
203-440-3
106-90-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2,3-epoxypropyl methacrylate; glycidyl methacrylate
203-441-9
106-91-2
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; STOT RE 1; Eye Dam. 1; Skin Corr. 1C; Skin Sens. 1
2,3-epoxypropyl-2-ethylcyclohexyl ether; ethylcyclohexylglycidyl ether
-
130014-35-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,4,4-trimethylhexamethylene-1,6-di-isocyanate
239-714-4
15646-96-5
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
2,4,4-trimethylpent-1-ene
203-486-4
107-39-1
Flam. Liq. 2
2,4,5-trimethylaniline
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane; metaldehyde
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
2,4,6-tri-tert-butylphenyl 2-butyl-2-ethyl-1,3-propanediolphosphite
423-560-1
161717-32-4
Skin Sens. 1
2,4,6-trichloro-1,3,5-triazine; cyanuric chloride
203-614-9
108-77-0
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,4,6-trimethyl-1,3,5-trioxane; paraldehyde
204-639-8
123-63-7
Flam. Liq. 3
2,4,6-trinitrotoluene; TNT
204-289-6
118-96-7
Expl. 1.1; Acute Tox. 3; STOT RE 2
2,4-bis(((2-(dimethylammonio)ethyloxy)carbonyl)phen-2-ylazo)benzene-1,3-diol sulfate
429-610-9
1030366-98-3
Acute Tox. 4; Eye Dam. 1
2,4-bis(((2-(dimethylammonio)ethyloxy)carbonyl)phen-2-ylazo)benzene-1,3-diolbis(methanesulfonate)
429-600-4
1026988-42-0
Acute Tox. 4; Eye Dam. 1
2,4-bis[2,2'-[2-(N, N-dimethylamino)ethyloxycarbonyl]phenylazo]-1,3-dihydroxybenzene, dihydrochloride
BASISCH GELB 8511
407-010-8
118208-02-9
Acute Tox. 4; Eye Dam. 1
2,4-di-tert-butylcyclohexanone
CYCLOWOOD
405-340-7
13019-04-0
Skin Irrit. 2
2,4-dichloro-3-ethylphenol
PM 9879
401-060-4
121518-45-4
Skin Corr. 1B
2,4-dichlorophenol
204-429-6
120-83-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
2,4-dihydro-4-(4-(4-(4-hydroxyphenyl)-1-piperazinyl)phenyl)-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one
434-820-9
106461-41-0
STOT RE 2
2,4-dihydroxy-N-(2-methoxyphenyl)benzamide
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
2,4-dimethyl-6-(1-methyl-pentadecyl)phenol
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
2,4-dimethylpentane
203-548-0
108-08-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dinitrotoluene
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
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