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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 lipnja 2024. Database contains 4821 unique substances/entries.
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202-627-7
98-01-1
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
213-090-3
923-26-2
Eye Irrit. 2; Skin Sens. 1
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
213-611-4
994-05-8
Flam. Liq. 2; Acute Tox. 4; STOT SE 3
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
PAMPLEFLEUR
402-770-7
92585-24-5
Skin Sens. 1
202-039-0
91-08-7
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
202-547-2
96-96-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
202-448-4
95-76-1
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
424-530-0
93076-03-0
Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1
620-041-3
907204-31-3
Lact.
IMEXINE FAE
403-440-5
93633-79-5
Acute Tox. 4
425-370-4
93957-50-7
Skin Sens. 1
213-048-4
919-30-2
Acute Tox. 4; Skin Corr. 1B
202-481-4
96-14-0
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
DD-63
404-590-4
90884-29-0
Skin Sens. 1
HOMOFARNESYLSÄURE
403-000-2
91853-67-7
Skin Irrit. 2
PLAKATROT Z; ROT BN
406-305-9
92952-81-3
Skin Irrit. 2
420-220-4
92771-56-7
Skin Sens. 1
202-214-1
93-05-0
Acute Tox. 3; Skin Corr. 1B
202-807-5
99-98-9
Acute Tox. 3
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
ACC ETHER
405-260-2
94050-51-8
Acute Tox. 4; Skin Sens. 1
202-453-1
95-80-7
yes
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-204-7
92-93-3
Carc. 1B
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
414-470-3
95885-13-5
Acute Tox. 4
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-095-6
91-76-9
Acute Tox. 4
202-708-7
98-86-2
Acute Tox. 4; Eye Irrit. 2
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
307-451-5
97659-46-6
yes
292-454-3
90622-53-0
Carc. 1B
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4
-
919-76-6
Acute Tox. 4
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
232-989-1
9080-17-5
Skin Corr. 1B
232-565-6
9000-90-2
Resp. Sens. 1
A complex combination of hydrocarbons from the base-freed fraction obtained from the distillation of coal tar and boiling in the range of approximately 325°C to 365°C (617°F to 689°F). It contains predominantly anthracene and phenanthrene and their alkyl derivatives.
295-274-3
91995-14-1
Carc. 1B
A complex combination of hydrocarbons from the distillation of anthracene obtained by the crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of 330°C to 350°C (626°F to 662°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-275-9
91995-15-2
Carc. 1B; Muta. 1B
yes
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous coal high temperature tar and boiling in the approximate range of 350°C to 360°C (662°F to 680°F). It contains chiefly anthracene, carbazole and phenanthrene.
295-276-4
91995-16-3
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons from the distillation of anthracene obtained by crystallization of anthracene oil from bituminous high temperature tar and boiling in the range of approximately 290°C to 340°C (554°F to 644°F). It contains chiefly trinuclear aromatics and their dihydro derivatives.
295-278-5
91995-17-4
Carc. 1B; Muta. 1B
yes
The anthracene-rich solid obtained by the crystallization and centrifuging of anthracene oil. It is composed primarily of anthracene, carbazole and phenanthrene.
292-603-2
90640-81-6
Carc. 1B; Muta. 1B
yes
The oil remaining after the removal, by a crystallization process, of an anthracene-rich solid (anthracene paste) from anthracene oil. It is composed primarily of two, three and four membered aromatic compounds.
292-604-8
90640-82-7
Carc. 1B; Muta. 1B
yes
A complex combination of polycyclic aromatic hydrocarbons obtained from coal tar having an approximate distillation range of 300°C to 400°C (572°F to 752°F). Composed primarily of phenanthrene, anthracene and carbazole
292-602-7
90640-80-5
Carc. 1B
yes
292-697-5
90989-41-6
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by separation from the platformate-containing fraction. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 (primarily C8) and can contain nonaromatic hydrocarbons, both boiling in the range of approximately 130°C to 200°C (266°F to 392°F).
297-401-8
93571-75-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
292-698-0
90989-42-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
295-279-0
91995-18-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
292-695-4
90989-39-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained from the evaporation of solvent under vacuum from polymerized hydrocarbon resin. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C9 and boiling in the range of approximately 120°C to 215°C (248°F to 419°F).
295-281-1
91995-20-9
Carc. 1B; Muta. 1B
292-694-9
90989-38-1
Carc. 1B; Muta. 1B
295-551-9
92062-36-7
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons produced by the distillation of the products from a steam cracking process treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly greater than C10 and boiling in the range of approximately 150°C to 320°C (302°F to 608°F).
292-621-0
90640-98-5
Asp. Tox. 1
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
202-710-8
98-88-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
201-990-9
90-41-5
Carc. 2; Acute Tox. 4
202-110-6
91-95-2
Carc. 1B; Muta. 2
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-328-1
94-37-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
-
90568-23-3
yes
232-572-4
9001-00-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
DBBT
402-210-1
99688-47-8
STOT RE 2; Skin Sens. 1
202-496-6
96-29-7
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3; STOT SE 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
202-318-7
94-26-8
yes
PIGMENTGELB 82 897
400-710-4
94612-72-3
Acute Tox. 4
202-759-5
99-49-0
Skin Sens. 1
232-734-4
9012-54-8
Resp. Sens. 1
618-392-2
9004-70-0
Expl. 1.1
213-666-4
999-81-5
Acute Tox. 4
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
304-236-8
94247-67-3
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
232-671-2
9004-07-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
202-704-5
98-82-8
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2

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