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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 dubna 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
barium chloride
233-788-1
10361-37-2
Acute Tox. 3; Acute Tox. 4
barium perchlorate
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
barium peroxide
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
benomyl (ISO);methyl 1-(butylcarbamoyl)benzimidazol-2-ylcarbamate
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
bensultap (ISO); 1,3-bis(phenylsulfonylthio)-2-(N,N-dimethylamino)propane
605-769-1
17606-31-4
Acute Tox. 4
benzaldehyde
202-860-4
100-52-7
Acute Tox. 4
benzo[e]pyrene
205-892-7
192-97-2
Carc. 1B
Benzo[ghi]perylene
205-883-8
191-24-2
yes
benzo[rst]pentaphene
205-877-5
189-55-9
Carc. 1B; Muta. 2
benzoic acid, N-tert-butyl-N'-(4-chlorobenzoyl)hydrazide
431-600-4
112226-61-6
Skin Sens. 1
benzonitrile
202-855-7
100-47-0
Acute Tox. 4
benzothiazole-2-thiol
205-736-8
149-30-4
Skin Sens. 1
benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide
691-719-4
1072957-71-1
Acute Tox. 3
benzthiazuron (ISO); 1-benzothiazol-2-yl-3-methylurea
217-685-9
1929-88-0
Acute Tox. 4
benzyl alcohol
202-859-9
100-51-6
Acute Tox. 4
benzyl benzoate
204-402-9
120-51-4
Acute Tox. 4
benzyl salicylate
204-262-9
118-58-1
Skin Sens. 1B
benzyl violet 4B; α-[4-(4-dimethylamino-α-{4-[ethyl(3-sodiosulphonato benzyl)amino] phenyl}benzylidene)cyclohexa-2,5-dienylidene(ethyl)ammonio]toluene-3-sulphonate
216-901-9
1694-09-3
Carc. 2
benzyl(S)-2-[(2'-cyanobiphenyl-4-ylmethyl)pentanoylamino]-3-methylbutyrate
427-470-3
137864-22-3
Acute Tox. 4; Skin Sens. 1
benzyl-2-hydroxydodecyldi; methylammonium benzoate
B 2049
402-610-6
113694-52-3
Skin Corr. 1B; Acute Tox. 4
benzyl-N-(2-(2-methoxyphenoxy)ethyl)amine hydrochloride
BM 96.0258.HCL
428-290-8
120606-08-8
Acute Tox. 4; Eye Dam. 1
benzylamine
202-854-1
100-46-9
Acute Tox. 4; Skin Corr. 1B
benzyldimethylamine
203-149-1
103-83-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
benzyldimethyloctadecylammonium 3-nitrobenzenesulfonate
CA10
405-330-2
124088-59-1
Skin Irrit. 2; Eye Dam. 1
benzyltributylammonium 4-hydroxynaphthalene-1-sulphonate
BONTRON P-51
402-240-5
102561-46-6
Acute Tox. 4
beryllium oxide
215-133-1
1304-56-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Beta-hexabromocyclododecane
603-802-4
134237-51-7
yes
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
bis(1-methylethyl)-dimethoxysilane
EURENOR 5021; PSX 872
421-540-7
18230-61-0
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
bis(2,4,4-trimethylpentyl)dithiophosphonic acid
420-160-9
107667-02-7
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
bis(2,4,6-trinitrophenyl)amine; hexyl
205-037-8
131-73-7
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
bis(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphinoxide
CGI 403
412-010-6
145052-34-2
Skin Sens. 1
bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme
205-594-7
143-24-8
Repr. 1B
yes
bis(2-chloroethyl) ether
203-870-1
111-44-4
Carc. 2; Acute Tox. 2; Acute Tox. 1
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
Repr. 1B
yes
bis(2-ethylhexyl)-4,5-epoxycyclohexane-1,2-dicarboxylate
430-700-5
10138-36-0
Skin Sens. 1
bis(2-methoxyethyl) ether
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
bis(2-methoxyethyl) phthalate
204-212-6
117-82-8
Repr. 1B
yes
bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane
DESMOPHEN VP-LS 2973 E; DESMOPHEN VP-LS 2975 E; DESMOPHEN VP-LS 2985 E
412-060-9
136210-32-7
Skin Sens. 1
bis(8-hydroxyquinolinium) sulphate
205-137-1
134-31-6
Acute Tox. 4
bis(hydrogenated tallow C16-18-alkyl)hydroxylamine
418-370-0
143925-92-2
Skin Sens. 1
bis(hydroxylammonium) sulfate; hydroxylamine sulfate (2:1)
233-118-8
10039-54-0
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate
SAFRANIN SHMN
406-770-8
149057-64-7
STOT RE 2; Eye Dam. 1; Skin Sens. 1
bis(N-hydroxy-N-nitrosocyclohexylaminato-O,O')copper; bis(N-cyclohexyl-diazenium-dioxy)-copper; [Cu-HDO]
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
Bis(pentabromophenyl) ether; decabromodiphenyl ether; DecaBDE
214-604-9
1163-19-5
yes
bis(η5-cyclopentadienyl)-bis(2,6-difluoro-3-[pyrrol-1-yl]-phenyl)titanium
CGI 784
412-000-1
125051-32-3
Flam. Sol. 1; Repr. 2; STOT RE 2
bis-[4-(2,3-epoxipropoxi)phenyl]propane
216-823-5
1675-54-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bis[4-(ethenyloxy)butyl] 1,3-benzenedicarboxylate
VECTOMER E2200
413-930-0
130066-57-8
Skin Sens. 1
bis[tributyl 4-(methylbenzyl)ammonium] 1,5-naphthalenedisulfonate
MCP-304
415-210-1
160236-81-7
Acute Tox. 4; Eye Dam. 1
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