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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 srpnja 2024. Database contains 4821 unique substances/entries.
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236-948-9
13560-89-9
yes
603-921-1
135410-20-7
Acute Tox. 4
236-881-5
13530-68-2
yes
603-902-8
13517-20-9
yes
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
OXAMITOL
412-510-4
135043-64-0
Acute Tox. 4; Skin Sens. 1
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
205-182-7
135-19-3
Acute Tox. 4
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
236-691-2
13465-08-2
Expl. 1.1; Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
236-675-5
13463-67-7
Carc. 2
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
236-669-2
13463-39-3
Flam. Liq. 2; Carc. 2; Repr. 1B; Acute Tox. 2
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
236-666-6
13462-90-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
236-665-0
13462-88-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
236-656-1
13457-18-6
Acute Tox. 4
-
13451-08-6
Skin Corr. 1B
215-709-2
1344-81-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
236-542-1
13424-46-9
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
236-542-1
13424-46-9
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
236-542-1
13424-46-9
yes
603-804-5
134237-52-8
yes
603-802-4
134237-51-7
yes
603-801-9
134237-50-6
yes
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
205-138-7
134-32-7
Acute Tox. 4
205-137-1
134-31-6
Acute Tox. 4
406-850-2
133855-98-8
Carc. 2; Repr. 1B
215-657-0
1338-02-9
Flam. Liq. 3; Acute Tox. 4
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
236-412-4
13360-57-1
Carc. 1B; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
215-648-1
1336-36-3
STOT RE 2
215-647-6
1336-21-6
Skin Corr. 1B
236-407-7
13356-08-6
Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
HOSTALUX VP 3481-1 HOSTALUX N2R
402-120-2
133514-97-3
Skin Corr. 1B; STOT RE 2; Skin Sens. 1
215-630-3
1335-32-6
Carc. 2; Repr. 1A; STOT RE 2
215-629-8
1335-31-5
Expl. 1.1; Acute Tox. 3; STOT RE 2
GABAPENTINE ETHYL ESTER; PD 137016
415-970-4
133481-10-4
Acute Tox. 4; STOT RE 2
CIN 10097929
418-320-8
133467-41-1
Acute Tox. 4
444-350-6
133413-70-4
Eye Irrit. 2
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
429-380-1
133336-92-2
Skin Sens. 1
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
215-607-8
1333-82-0
Ox. Sol. 1; Carc. 1A; Muta. 1B; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
yes
215-605-7
1333-74-0
Flam. Gas 1; Press. Gas
215-604-1
1333-73-9
yes
215-582-3
1333-22-8
Acute Tox. 4
215-572-9
1332-65-6
Acute Tox. 4; Acute Tox. 3
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
215-548-8
1330-78-5
Acute Tox. 4
215-548-8
1330-78-5
STOT SE 1
215-540-4
1330-43-4
Repr. 1B
yes
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
205-087-0
133-06-2
Carc. 2; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
NITROBLAU; NITROBLUE
407-020-2
132885-85-9
Acute Tox. 4; Skin Sens. 1
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
429-220-9
132584-17-9
Skin Sens. 1
236-236-8
13252-13-6
yes
236-232-6
13250-12-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
-
132207-32-0
Carc. 1A; STOT RE 1
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
215-316-6
1321-23-9
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
205-073-4
132-67-2
Acute Tox. 4
205-057-7
132-32-1
Carc. 1B
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
236-152-1
13194-48-4
Acute Tox. 2; Acute Tox. 1; Acute Tox. 3; Skin Sens. 1
215-293-2
1319-77-3
Acute Tox. 3; Skin Corr. 1B
215-290-6
1319-46-6
yes
603-524-3
131860-33-8
Acute Tox. 3
236-129-6
13181-17-4
Acute Tox. 4
603-520-1
131807-57-3
STOT RE 2
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
215-273-3
1317-42-6
Skin Sens. 1
215-270-7
1317-39-1
Acute Tox. 4; Eye Dam. 1
215-267-0
1317-36-8
yes
ROT CO
411-440-1
131657-78-8
Acute Tox. 4; Skin Sens. 1
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
215-245-0
1314-85-8
Flam. Sol. 2; Water-react. 1; Acute Tox. 4
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
215-242-4
1314-80-3
Flam. Sol. 1; Water-react. 1; Acute Tox. 4
215-239-8
1314-62-1
Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3
215-236-1
1314-56-3
Skin Corr. 1A
215-235-6
1314-41-6
yes
215-217-8
1314-06-3
Carc. 1A; STOT RE 1; Skin Sens. 1
215-216-2
1314-05-2
Carc. 1A; STOT RE 1; Skin Sens. 1
-
1314-04-1
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
236-068-5
13138-45-9
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
215-215-7
1313-99-1
Carc. 1A; STOT RE 1; Skin Sens. 1
215-211-5
1313-82-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
215-202-6
1313-13-9
Acute Tox. 4
236-049-1
13121-70-5
Acute Tox. 4
215-197-0
1312-73-8
Skin Corr. 1B
236-035-5
13108-52-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
DIRECT YELLOW 86 TETRAMETHYLAMMONIUM SALT; YELLOW DYE FOR PAINTJET PRINT CARTRIDGE
405-950-3
131013-83-7
Acute Tox. 3
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
215-185-5
1310-73-2
Skin Corr. 1A
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
205-042-5
131-89-5
Acute Tox. 3
205-037-8
131-73-7
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
205-017-9
131-18-0
Repr. 1B
yes
205-016-3
131-17-9
Acute Tox. 4
215-175-0
1309-64-4
Carc. 2
CA 946 A
415-580-4
130841-23-5
Acute Tox. 4; Skin Sens. 1
PFMT 1848
410-060-3
130728-76-6
Muta. 2; Skin Sens. 1
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
215-154-6
1307-96-6
Acute Tox. 4; Skin Sens. 1
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
424-170-4
130603-71-3
Skin Sens. 1
215-147-8
1306-23-6
Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4
yes
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Monteponite (CdO) EC / List no: - | CAS no: 12139-21-8
215-146-2
1306-19-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
yes
215-142-0
1305-99-3
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1; Eye Dam. 1
235-921-9
13048-33-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
603-411-9
1303-96-4
Repr. 1B
yes
215-125-8
1303-86-2
Repr. 1B
yes
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
215-114-8
1303-00-0
Repr. 1B; Carc. 1B; STOT RE 1
BONTRON E-88
406-890-0
130296-87-6
Acute Tox. 4
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
REACTIVE RED SR 6947; ROUGE REACTIF SR 6947
411-540-5
130201-57-9
Eye Dam. 1; Skin Sens. 1
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
CYCLOWOOD
405-340-7
13019-04-0
Skin Irrit. 2
EAPOXC
421-790-7
13014-29-4
Water-react. 1; Skin Corr. 1A
VECTOMER E2200
413-930-0
130066-57-8
Skin Sens. 1
641-410-5
130066-44-3
Skin Sens. 1A
-
130014-35-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
204-987-0
130-37-0
Eye Irrit. 2; Skin Irrit. 2
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
430-800-9
129228-21-3
Skin Irrit. 2
406-970-5
129228-11-1
Skin Irrit. 2
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
404-600-7
129009-88-7
Skin Sens. 1
204-961-9
129-73-7
Carc. 2; Muta. 2
204-959-8
129-67-9
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
204-927-3
129-00-0
yes
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
430-770-7
128173-52-4
Acute Tox. 4; Skin Sens. 1
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
204-825-9
127-18-4
Carc. 2
DCPMS; DYNASYLAN 9415; EURENOR 5023; SAN-30; WACKER SILAN CP2-DIMETHOXY; Z-6228
404-370-8
126990-35-0
Skin Irrit. 2; Eye Dam. 1
-
12673-58-4
Carc. 1A; STOT RE 1; Skin Sens. 1
BLUE GS 1259 R5
407-230-4
126637-70-5
Acute Tox. 4; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
603-146-9
126535-15-7
Carc. 2
235-752-0
12653-76-8
Carc. 1A; STOT RE 1; Skin Sens. 1
235-727-4
12626-81-2
yes
235-723-2
12619-90-8
Carc. 1A; STOT RE 1; Skin Sens. 1
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
204-818-0
126-99-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-817-5
126-98-7
Flam. Liq. 2; Acute Tox. 3; Skin Sens. 1
204-811-2
126-91-0
Skin Sens. 1B
204-810-7
126-90-9
Skin Sens. 1B
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
204-783-1
126-33-0
Acute Tox. 4
425-860-8
125971-57-5
Skin Sens. 1
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
235-702-8
12578-12-0
yes
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
423-240-1
125474-34-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1

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