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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
benzene
200-753-7
71-43-2
Flam. Liq. 2; Carc. 1A; Muta. 1B; STOT RE 1; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2
benzene-1,2,4-tricarboxylic acid 1,2-anhydride; trimellitic anhydride
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
benzene-1,2:4,5-tetracarboxylic dianhydride; benzene-1,2:4,5-tetracarboxylic dianhydride; pyromellitic dianhydride
201-898-9
89-32-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
benzene-1,4-diamine dihydrochloride; p-phenylenediamine dihydrochloride
210-834-9
624-18-0
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
benzidine; 1,1'-biphenyl-4,4'-diamine; 4,4'-diaminobiphenyl; biphenyl-4,4'-ylenediamine
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
benzo[a]pyrene; benzo[def]chrysene
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
benzo[e]pyrene
205-892-7
192-97-2
Carc. 1B
Benzo[ghi]perylene
205-883-8
191-24-2
yes
benzo[j]fluoranthene
205-910-3
205-82-3
Carc. 1B
benzo[k]fluoranthene
205-916-6
207-08-9
Carc. 1B
yes
benzo[rst]pentaphene
205-877-5
189-55-9
Carc. 1B; Muta. 2
benzoic acid
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
Benzol forerunnings (coal); Light Oil Redistillate, low boiling [The distillate from coke oven light oil having an approximate distillation range below 100 o C (212 °F). Composed primarily of C4 to C6 aliphatic hydrocarbons.]
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
benzonitrile
202-855-7
100-47-0
Acute Tox. 4
benzophenone-3,3',4,4'-tetracarboxylic dianhydride; 4,4'-carbonyldi(phthalic anhydride)
219-348-1
2421-28-5
Eye Irrit. 2; STOT SE 3
benzothiazole-2-thiol
205-736-8
149-30-4
Skin Sens. 1
benzoyl chloride
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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 chloroformate
207-925-0
501-53-1
Skin Corr. 1B
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
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
beryllium
231-150-7
7440-41-7
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
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
binapacryl (ISO); 2-sec-butyl-4,6-dinitrophenyl-3-methylcrotonate
207-612-9
485-31-4
Repr. 1B; Acute Tox. 4
biphenyl-2-ylamine
201-990-9
90-41-5
Carc. 2; Acute Tox. 4
biphenyl-3,3', 4,4'-tetrayltetraamine; diaminobenzidine
202-110-6
91-95-2
Carc. 1B; Muta. 2
biphenyl-4-ylamine; xenylamine; 4-aminobiphenyl
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
biphenyl; diphenyl
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
bis(1,2,3-trithiacyclohexyldimethylammonium) oxalate; thiocyclam-oxalate
250-859-2
31895-22-4
Acute Tox. 4
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-(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) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
Repr. 1B
yes
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-(trimethoxysilyl)propyl)amine
280-084-5
82985-35-1
Eye Dam. 1
bis(4-hydroxy-N-methylanilinium) sulphate
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
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(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-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(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
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