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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 svibnja 2024. Database contains 4821 unique substances/entries.
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M1
422-060-0
137390-08-0
Acute Tox. 2
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
419-270-1
123599-82-6
Eye Irrit. 2
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
425-520-9
197179-61-6
Eye Dam. 1
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
603-921-1
135410-20-7
Acute Tox. 4
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
203-466-5
107-13-1
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
204-673-3
124-04-9
Eye Irrit. 2
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
240-896-2
16871-90-2
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-968-3
16919-19-0
Acute Tox. 3
701-376-5
1372804-76-6
yes
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
603-801-9
134237-50-6
yes
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
604-314-4
142844-00-6
yes
215-647-6
1336-21-6
Skin Corr. 1B
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
235-185-9
12125-01-8
Acute Tox. 3
433-560-3
15375-21-0
Repr. 2
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
204-371-1
120-12-7
yes
233-047-2
10025-91-9
Skin Corr. 1B
215-175-0
1309-64-4
Carc. 2
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
-
132207-32-0
Carc. 1A; STOT RE 1
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
603-524-3
131860-33-8
Acute Tox. 3
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4
233-788-1
10361-37-2
Acute Tox. 3; Acute Tox. 4
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
605-769-1
17606-31-4
Acute Tox. 4
202-860-4
100-52-7
Acute Tox. 4
205-892-7
192-97-2
Carc. 1B
205-883-8
191-24-2
yes
205-877-5
189-55-9
Carc. 1B; Muta. 2
431-600-4
112226-61-6
Skin Sens. 1
202-855-7
100-47-0
Acute Tox. 4
205-736-8
149-30-4
Skin Sens. 1
691-719-4
1072957-71-1
Acute Tox. 3
217-685-9
1929-88-0
Acute Tox. 4
202-859-9
100-51-6
Acute Tox. 4
204-402-9
120-51-4
Acute Tox. 4
204-262-9
118-58-1
Skin Sens. 1B
216-901-9
1694-09-3
Carc. 2
427-470-3
137864-22-3
Acute Tox. 4; Skin Sens. 1
B 2049
402-610-6
113694-52-3
Skin Corr. 1B; Acute Tox. 4
BM 96.0258.HCL
428-290-8
120606-08-8
Acute Tox. 4; Eye Dam. 1
202-854-1
100-46-9
Acute Tox. 4; Skin Corr. 1B
203-149-1
103-83-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
CA10
405-330-2
124088-59-1
Skin Irrit. 2; Eye Dam. 1
BONTRON P-51
402-240-5
102561-46-6
Acute Tox. 4
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
603-802-4
134237-51-7
yes
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
EURENOR 5021; PSX 872
421-540-7
18230-61-0
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
420-160-9
107667-02-7
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
205-037-8
131-73-7
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
CGI 403
412-010-6
145052-34-2
Skin Sens. 1
205-594-7
143-24-8
Repr. 1B
yes
203-870-1
111-44-4
Carc. 2; Acute Tox. 2; Acute Tox. 1
204-211-0
117-81-7
Repr. 1B
yes
430-700-5
10138-36-0
Skin Sens. 1
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
204-212-6
117-82-8
Repr. 1B
yes
DESMOPHEN VP-LS 2973 E; DESMOPHEN VP-LS 2975 E; DESMOPHEN VP-LS 2985 E
412-060-9
136210-32-7
Skin Sens. 1
205-137-1
134-31-6
Acute Tox. 4
418-370-0
143925-92-2
Skin Sens. 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
SAFRANIN SHMN
406-770-8
149057-64-7
STOT RE 2; Eye Dam. 1; Skin Sens. 1
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
214-604-9
1163-19-5
yes
CGI 784
412-000-1
125051-32-3
Flam. Sol. 1; Repr. 2; STOT RE 2
216-823-5
1675-54-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
VECTOMER E2200
413-930-0
130066-57-8
Skin Sens. 1
MCP-304
415-210-1
160236-81-7
Acute Tox. 4; Eye Dam. 1

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