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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 26 April 2024. Database contains 4821 unique substances/entries.

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Showing 1,401 - 1,500 of 4,821 results.

Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
bis(1-methylethyl)-dimethoxysilane EURENOR 5021; PSX 872	421-540-7	18230-61-0	Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
bis(2,2,6,6-tetramethyl-4-piperidyl) succinate TINUVIN 780	402-940-0	62782-03-0	Eye Irrit. 2
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-dimethylaminoethyl)(methyl)amine	221-201-1	3030-47-5	Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
bis(2-ethylhexyl) dithiodiacetate DI(2-ETHYLHEXYL)DITHIODIGLYKOLAT; DP 327	404-510-8	62268-47-7	Acute Tox. 4; Skin Sens. 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(3,5-di-tert-butylsalicylato-O1,O2)zinc BONTRON E-84; E-84	403-360-0	42405-40-3	Flam. Sol. 1; Acute Tox. 4
bis(3-(trimethoxysilyl)propyl)amine	280-084-5	82985-35-1	Eye Dam. 1
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(4-dodecylphenyl)iodonium hexafluoroantimonate	404-420-9	71786-70-4	Skin Sens. 1
bis(4-fluorophenyl)-methyl-(1,2,4-triazol-4-ylmethyl)silane hydrochloride U 9649	401-380-4	89066-61-5	Eye Irrit. 2
bis(4-hydroxy-N-methylanilinium) sulphate	200-237-1	55-55-0	Acute Tox. 4; STOT RE 2; Skin Sens. 1
bis(4-methylbenzoyl)peroxide INTEROX-PMBP-70W; INTEROX-PMPB-70W	407-950-9	895-85-2	Org. Perox. B
bis(8-hydroxyquinolinium) sulphate	205-137-1	134-31-6	Acute Tox. 4
bis(chloromethyl) ether; oxybis(chloromethane)	208-832-8	542-88-1	Flam. Liq. 2; Carc. 1A; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
bis(d-gluconato-O1,O2)nickel	276-205-6	71957-07-8	Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate) Z-27	421-660-1	-	Eye Dam. 1; Skin Sens. 1
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]	608-595-4	312600-89-8	Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 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(N-methyl-N-phenylhydrazine)sulfate GR101655A	423-170-1	618-26-8	Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Bis(pentabromophenyl) ether; decabromodiphenyl ether; DecaBDE	214-604-9	1163-19-5			yes
bis(piperidinothiocarbonyl) disulphide	202-328-1	94-37-1	Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Bis(tributyltin)oxide; TBTO	200-268-0	56-35-9			yes
bis(α,α-dimethylbenzyl) peroxide	201-279-3	80-43-3	Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
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-(6-hydroxy-4-methyl-5-(3-methylimidazolium-1-yl)-3-(4-phenylazo)-1H-pyridin-2-one)ethylene dilactate	421-560-6	-	STOT RE 2; Eye Dam. 1
bis-[4-(2,3-epoxipropoxi)phenyl]propane	216-823-5	1675-54-3	Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bis[(1-methylimidazol)-(2-ethyl-hexanoate)], zinc complex TK 10891; XB 4458; XW 528; ZK XB 4458	405-635-0	-	Skin Irrit. 2; Eye Dam. 1
bis[4-(ethenyloxy)butyl] 1,3-benzenedicarboxylate VECTOMER E2200	413-930-0	130066-57-8	Skin Sens. 1
bis[[2,2',2''-nitrilotris-[ethanolato]]-1-N,O]-bis[2-(2-methoxyethoxy)ethoxy]-titanium TITANCHELAT ETAM	410-500-4	357921-97-2	Eye Dam. 1
bis[tributyl 4-(methylbenzyl)ammonium] 1,5-naphthalenedisulfonate MCP-304	415-210-1	160236-81-7	Acute Tox. 4; Eye Dam. 1
bisphenol A; 4,4'-isopropylidenediphenol	201-245-8	80-05-7	Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1		yes
BK and JC viruses	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Blastomyces dermatitidis	-	-		F Fungi
Borate(2-), tetrahydroxybis[μ-(peroxy-κO1:κO2)]di-, sodium (1:2)	-	90568-23-3			yes
Borate(2-), tetrahydroxybis[μ-(peroxy-κO1:κO2)]di-, sodium, hydrate (1:2:6)	-	125022-34-6			yes
bordeaux mixture; reaction products of copper sulphate with calcium dihydroxide	616-932-1	8011-63-0	Acute Tox. 4; Eye Dam. 1
Bordetella bronchiseptica	-	-		B Bacteria and similar species
Bordetella parapertussis	-	-		B Bacteria and similar species
Bordetella pertussis	-	-		B Bacteria and similar species
boric acid	233-139-2	10043-35-3	Repr. 1B		yes
boric acid	234-343-4	11113-50-1	Repr. 1B		yes
Boric acid (H3BO3), disodium salt	-	22454-04-2			yes
Boric acid (H3BO3), sodium salt (1:1)	-	14890-53-0			yes
Boric acid (H3BO3), sodium salt, hydrate	-	25747-83-5			yes
Boric acid, sodium salt	215-604-1	1333-73-9			yes
boron tribromide	233-657-9	10294-33-4	Acute Tox. 2; Skin Corr. 1A
boron trichloride	233-658-4	10294-34-5	Press. Gas; Acute Tox. 2; Skin Corr. 1B
boron trifluoride	231-569-5	7637-07-2	Press. Gas; Acute Tox. 2; Skin Corr. 1A
Borrelia burgdorferi	-	-		B Bacteria and similar species
Borrelia duttonii	-	-		B Bacteria and similar species
Borrelia recurrentis	-	-		B Bacteria and similar species
Borrelia spp.	-	-		B Bacteria and similar species
Bovine spongiform encephalopathy (BSE) and other related animal TSEs	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
bromadiolone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-chromen-2-one	249-205-9	28772-56-7	Repr. 1B; Acute Tox. 1; STOT RE 1
bromelain, juice	232-572-4	9001-00-7	Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
bromine	231-778-1	7726-95-6	Acute Tox. 2; Skin Corr. 1A
bromoacetic acid	201-175-8	79-08-3	Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1
bromobenzene	203-623-8	108-86-1	Flam. Liq. 3; Skin Irrit. 2
bromobenzylbromotoluene, reaction mass of isomers DBBT	402-210-1	99688-47-8	STOT RE 2; Skin Sens. 1
bromoethane; ethyl bromide	200-825-8	74-96-4	Flam. Liq. 2; Carc. 2; Acute Tox. 4
bromoethylene	209-800-6	593-60-2	Press. Gas; Flam. Gas 1; Carc. 1B
bromofenoxim (ISO); 3,5-dibromo-4-hydroxybenzaldehyde-O-(2,4-dinitrophenyl)-oxime	236-129-6	13181-17-4	Acute Tox. 4
bromoform; tribromomethane	200-854-6	75-25-2	Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
bromomethane; methylbromide	200-813-2	74-83-9	Press. Gas; Muta. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
bromophos (ISO); O-4-bromo-2,5-dichlorophenyl O,O-dimethyl phosphorothioate	218-277-3	2104-96-3	Acute Tox. 4
bromophos-ethyl (ISO); O-4-bromo-2,5-dichlorophenyl; O,O-diethyl phosphorothioate	225-399-0	4824-78-6	Acute Tox. 3; Acute Tox. 4
bromoxynil (ISO) 3,5-dibromo-4-hydroxybenzonitrile; bromoxynil phenol show/hide 2,6-dibromo-4-cyanophenyl butyrate EC / List no: 223-374-9 \| CAS no: 3861-41-4 2,6-dibromo-4-cyanophenyl heptanoate EC / List no: 260-300-4 \| CAS no: 56634-95-8 2,6-dibromo-4-cyanophenyl octanoate EC / List no: 216-885-3 \| CAS no: 1689-99-2 3,5-dibromo-4-hydroxybenzonitrile EC / List no: 216-882-7 \| CAS no: 1689-84-5	216-882-7	1689-84-5	Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
bromoxynil heptanoate (ISO); 2,6-dibromo-4-cyanophenyl heptanoate	260-300-4	56634-95-8	Repr. 2; Acute Tox. 4; Skin Sens. 1
bromoxynil octanoate (ISO); 2,6-dibromo-4-cyanophenyl octanoate	216-885-3	1689-99-2	Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 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
Brucella abortus	-	-		B Bacteria and similar species
Brucella canis	-	-		B Bacteria and similar species
Brucella melitensis	-	-		B Bacteria and similar species
Brucella suis	-	-		B Bacteria and similar species
brucine nitrate	227-317-9	5786-97-0	Acute Tox. 2
brucine sulphate	225-432-9	4845-99-2	Acute Tox. 2
brucine; 2,3-dimethoxystrychnine	206-614-7	357-57-3	Acute Tox. 2
Brugia malayi	-	-		P Parasites
Brugia pahangi	-	-		P Parasites
bufa-4,20,22-trienolide, 6-(acetyloxy)-3-(β-D-glucopyranosyloxy)-8,14-dihydroxy-, (3β, 6β)-; red squill; scilliroside	208-077-4	507-60-8	Acute Tox. 2
bufencarb (ISO); reaction mass of 3-(1-methylbutyl)phenyl N-methylcarbamate and 3-(1-ethylpropyl)phenyl N-methylcarbamate	620-359-2	8065-36-9	Acute Tox. 3
Buffalopox virus	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
bunsenite	-	34492-97-2	Carc. 1A; STOT RE 1; Skin Sens. 1
Bunyamwera virus	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
bupirimate (ISO); 5-butyl-2-ethylamino-6-methylpyrimidin-4-yl dimethylsulphamate	255-391-2	41483-43-6	Carc. 2; Skin Sens. 1B
Burkholderia mallei	-	-		B Bacteria and similar species
Burkholderia pseudomallei	-	-		B Bacteria and similar species
but-1-ene	203-449-2	106-98-9	Flam. Gas 1; Press. Gas
but-2-yne-1,4-diol; 2-butyne-1,4-diol	203-788-6	110-65-6	Skin Corr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1

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EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

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

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Last updated 26 April 2024. Database contains 4821 unique substances/entries.

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