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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
200-835-2
75-05-8
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2
200-865-6
75-36-5
Flam. Liq. 2; Skin Corr. 1B
200-816-9
74-86-2
Flam. Gas 1; Press. Gas
277-704-1
74070-46-5
Carc. 2; Skin Sens. 1A
201-173-7
79-06-1
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
yes
201-177-9
79-10-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
231-208-1
7446-70-0
Skin Corr. 1B
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
231-601-8
7647-18-9
Skin Corr. 1B
232-009-2
7783-56-4
Acute Tox. 3
231-148-6
7440-38-2
Acute Tox. 3
231-901-9
7778-39-4
Carc. 1A; Acute Tox. 3
yes
232-066-3
7784-42-1
Flam. Gas 1; Press. Gas; Acute Tox. 2; STOT RE 2
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
212-010-4
741-58-2
Acute Tox. 4
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
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
404-420-9
71786-70-4
Skin Sens. 1
276-205-6
71957-07-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-569-5
7637-07-2
Press. Gas; Acute Tox. 2; Skin Corr. 1A
231-778-1
7726-95-6
Acute Tox. 2; Skin Corr. 1A
201-175-8
79-08-3
Acute Tox. 3; Skin Corr. 1A; Skin Sens. 1
200-825-8
74-96-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4
200-854-6
75-25-2
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
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
200-751-6
71-36-3
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
201-159-0
78-93-3
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
230-358-5
7067-44-9
Acute Tox. 4
640-998-0
7790-78-5
yes
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
231-152-8
7440-43-9
yes
231-152-8
7440-43-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
231-152-8
7440-43-9
Pyr. Sol. 1; Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
231-179-5
7440-70-2
Water-react. 2
231-904-5
7778-44-1
yes
200-848-3
75-20-7
Water-react. 1
232-189-2
7789-78-8
Water-react. 1
231-908-7
7778-54-3
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1B
200-843-6
75-15-0
Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
212-324-1
786-19-6
Acute Tox. 3
231-959-5
7782-50-5
Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
201-178-4
79-11-8
Acute Tox. 3; Skin Corr. 1B
201-171-6
79-04-9
Acute Tox. 3; STOT RE 1; Skin Corr. 1A
200-830-5
75-00-3
Flam. Gas 1; Press. Gas; Carc. 2
200-817-4
74-87-3
Flam. Gas 1; Press. Gas; Carc. 2; STOT RE 2
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
231-801-5
7738-94-5
yes
279-116-0
79234-33-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
278-290-5
75660-25-2
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
231-187-9
7443-70-1
Acute Tox. 4
201-069-1
77-92-9
Eye Irrit. 2; STOT SE 3
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
231-842-9
7758-89-6
Acute Tox. 4
231-159-6
7440-50-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2
231-847-6
7758-98-7
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
231-720-5
7700-17-6
Acute Tox. 3
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
200-824-2
74-95-3
Acute Tox. 4
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
201-207-0
79-43-6
Skin Corr. 1A
201-199-9
79-36-7
Skin Corr. 1A
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
200-838-9
75-09-2
Carc. 2
620-436-0
75736-33-3
Eye Irrit. 2
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
425-380-9
7397-46-8
Pyr. Liq. 1; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
200-760-5
71-63-6
Acute Tox. 3; STOT RE 2
276-090-2
71850-09-4
Repr. 1B
yes
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
617-485-5
76714-88-0
Acute Tox. 4
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
427-300-8
79463-77-7
Eye Dam. 1
278-355-8
75980-60-8
Repr. 2
231-781-8
7727-21-1
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1

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