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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
427-230-8
5571-36-8
Repr. 1B; STOT RE 2
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
293-901-5
91648-39-4
Repr. 1B; STOT RE 1
222-883-3
3648-18-8
Repr. 1B; STOT RE 1
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
259-537-6
55219-65-3
Repr. 1B; Lact.; Acute Tox. 4
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
THTPA
407-330-8
61571-06-0
Repr. 1B; Eye Dam. 1
206-356-5
330-55-2
Repr. 1B; Carc. 2; Acute Tox. 4; STOT RE 2
215-114-8
1303-00-0
Repr. 1B; Carc. 1B; STOT RE 1
262-104-4
60207-90-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
262-661-3
61213-25-0
Repr. 1B; Acute Tox. 4; Skin Sens. 1
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
206-019-2
288-32-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1C
210-894-6
625-45-6
Repr. 1B; Acute Tox. 4; Skin Corr. 1B
yes
SEL DE VILSMEIER-HAACK
425-970-6
3724-43-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1A
-
-
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
254-408-0
39300-45-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
215-925-7
1453-58-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Corr. 1; Eye Dam. 1
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115850-69-6
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
253-704-7
37894-46-5
Repr. 1B; Acute Tox. 4; STOT RE 2
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
206-022-9
288-88-0
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
204-624-6
123-39-7
Repr. 1B; Acute Tox. 4
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
yes
207-612-9
485-31-4
Repr. 1B; Acute Tox. 4
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
265-667-4
65277-42-1
Repr. 1B; Acute Tox. 3; STOT RE 2
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
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Dinoseb acetate EC / List no: 220-560-1 | CAS no: 2813-95-8
Ammonium 2-sec-butyl-4,6-dinitrophenolate EC / List no: 228-858-3 | CAS no: 6365-83-9
2-sec-butyl-4,6-dinitrophenol, compound with 2,2'-iminodiethanol (1:1) EC / List no: 258-532-6 | CAS no: 53404-43-6
2-sec-butyl-4,6-dinitrophenol, compound with 1-aminopropan-2-ol (1:1) EC / List no: 275-931-0 | CAS no: 71735-19-8
Binapacryl EC / List no: 207-612-9 | CAS no: 485-31-4
Sodium 2-(1-methylpropyl)-4,6-dinitrophenolate EC / List no: 252-331-7 | CAS no: 35040-03-0
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-
Repr. 1B; Acute Tox. 3; Eye Irrit. 2

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