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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 lipnja 2024. Database contains 4821 unique substances/entries.
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950-299-5
-
yes
939-993-9
-
yes
939-460-0
1471311-26-8
yes
938-618-6
-
yes
936-037-2
-
yes
show/hide
Proteinase, rhizopus acid EC / List no: 812-486-9 | CAS no: 9074-09-3
Bacteria, complex with amylase and proteinase EC / List no: - | CAS no: 68920-42-3
Proteinase, Bacillus subtilis, sutilain EC / List no: 235-390-3 | CAS no: 12211-28-8
Amylase, mixed with proteinase, Bacillus cereus-fermented EC / List no: - | CAS no: 68909-35-3
Proteinase, microbial acid EC / List no: 256-862-5 | CAS no: 50936-52-2
Proteinase, oryzin EC / List no: 232-992-8 | CAS no: 9081-30-5
Proteinase, bacterial E 30 serine EC / List no: - | CAS no: 39369-34-1
Proteinase, Agkistrodon serine EC / List no: 232-933-6 | CAS no: 9046-56-4
Proteinase, pancreatic EC / List no: 232-626-7 | CAS no: 9001-72-3
Proteinase, Bacillus subtilis serine EC / List no: 266-557-9 | CAS no: 67051-83-6
Proteinase, Endothia aspartic EC / List no: 253-395-9 | CAS no: 37205-60-0
Thrombin EC / List no: 232-648-7 | CAS no: 9002-04-4
Proteinase, Myxobacter AL-1, II EC / List no: 276-716-4 | CAS no: 72561-05-8
Proteinase, serine EC / List no: 253-431-3 | CAS no: 37259-58-8
Proteinase, Serratia extracellular EC / List no: 253-457-5 | CAS no: 37312-62-2
Proteinase, Mucor aspartic EC / List no: 232-975-5 | CAS no: 9073-79-4
Proteinase, Aspergillus parasiticus neutral EC / List no: 254-418-5 | CAS no: 39335-09-6
Proteinase, Aspergillus niger neutral EC / List no: 254-422-7 | CAS no: 39346-39-9
Proteinase, Bacillus alcalophilus serine EC / List no: 306-090-0 | CAS no: 95979-76-3
Proteinase, Aspergillus acid EC / List no: 232-796-2 | CAS no: 9025-49-4
Proteinase, Bacillus neutral EC / List no: 278-547-1 | CAS no: 76774-43-1
Proteinase, Tritirachium album serine EC / List no: 254-457-8 | CAS no: 39450-01-6
Proteinase, Streptomyces griseus EC / List no: 232-909-5 | CAS no: 9036-06-0
Proteinase, Aspergillus melleus, semialkaline EC / List no: - | CAS no: 76106-83-7
Proteinase, Aspergillus neutral EC / List no: 278-588-5 | CAS no: 77000-13-6
Proteinase, Myxobacter α-lytic EC / List no: 253-448-6 | CAS no: 37288-76-9
Proteinase, Bacillus subtilis metallo- EC / List no: 232-991-2 | CAS no: 9080-56-2
Proteinase, serine (Tritirachium album) EC / List no: 686-165-5 | CAS no: 102925-54-2
Proteinase, Bacillus polymyxa neutral EC / List no: 255-914-4 | CAS no: 42613-33-2
Proteinase, Bacillus alkaline EC / List no: 232-972-9 | CAS no: 9073-77-2
Proteinase, Aspergillus alkaline EC / List no: 232-977-6 | CAS no: 9074-07-1
Proteinase, Bacillus licheniformis serine EC / List no: 279-361-3 | CAS no: 79986-26-8
Proteinase, Aspergillus oryzae neutral EC / List no: 232-990-7 | CAS no: 9080-55-1
Amylase, mixture with proteinase EC / List no: 685-079-5 | CAS no: 9001-11-0
Proteinase, Bacillus subtilis EC / List no: 257-520-8 | CAS no: 51931-23-8
Proteinase, microbial alkaline EC / List no: 256-863-0 | CAS no: 50936-53-3
Myxobacteralphalyticproteinase EC / List no: - | CAS no: 12585-31-8
Aspergillin M EC / List no: - | CAS no: 42615-60-1
Proteinase, aspartic EC / List no: 278-856-1 | CAS no: 78169-47-8
Proteinase, Staphylococcus aureus serine EC / List no: 259-611-8 | CAS no: 55354-32-0
Proteinase, Bothrops atrox serine EC / List no: 232-918-4 | CAS no: 9039-61-6
Proteinase, submandibular gland serine, A EC / List no: 279-893-6 | CAS no: 82047-85-6
Bacillus megaterium protease fermentation product EC / List no: - | CAS no: 68909-17-1
Proteinase, microbial neutral EC / List no: 232-966-6 | CAS no: 9068-59-1
934-013-6
39450-01-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
932-998-7
-
yes
931-756-8
-
yes
931-755-2
-
yes
931-754-7
-
yes
931-753-1
-
yes
915-270-3
-
yes
822-682-6
1417782-03-6
Skin Sens. 1
817-852-1
1228284-64-7
Carc. 2; Repr. 2
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
807-366-8
946578-00-3
Acute Tox. 4
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
show/hide
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
799-976-5
-
yes
show/hide
Stannane, dioctyl-, bis(coco acyloxy) derivs. EC / List no: 293-901-5 | CAS no: 91648-39-4
Dioctyltin dilaurate EC / List no: 222-883-3 | CAS no: 3648-18-8
799-973-9
-
yes
show/hide
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
799-972-3
-
yes
UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17
show/hide
Tetradecane, chloro derivs. EC / List no: - | CAS no: 198840-65-2
Alkanes, C14-17, chloro EC / List no: 287-477-0 | CAS no: 85535-85-9
Alkanes, C14-16, chloro EC / List no: 701-376-5 | CAS no: 1372804-76-6
di-, tri- and tetrachlorotetradecane EC / List no: 950-299-5 | CAS no: -
799-971-8
-
yes
show/hide
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
799-970-2
-
yes
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
701-394-3
1782069-81-1
yes
701-376-5
1372804-76-6
yes
701-225-3
1101132-67-5
Carc. 2; Repr. 2; STOT RE 2
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
700-242-3
62037-80-3
yes
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
692-456-8
688046-61-9
Carc. 2
691-719-4
1072957-71-1
Acute Tox. 3
688-331-2
874967-67-6
Carc. 2
687-833-9
1119449-38-5
yes
687-832-3
1119449-37-4
yes
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
682-362-5
12527-76-3
Acute Tox. 4
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
641-410-5
130066-44-3
Skin Sens. 1A
640-998-0
7790-78-5
yes
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
635-696-0
186825-39-8
yes
635-391-2
142731-63-3
yes
635-389-1
186825-36-5
yes
635-388-6
521947-27-3
yes
635-361-9
243973-20-8
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1A
630-448-8
62610-77-9
Acute Tox. 4; Skin Sens. 1
626-360-4
15244-35-6
yes
622-370-8
1522-92-5
yes
621-345-9
2315-67-5
yes
621-341-7
2315-61-9
yes
620-440-2
12510-42-8
Carc. 1A
620-436-0
75736-33-3
Eye Irrit. 2
620-432-9
2122-19-2
Repr. 2; Acute Tox. 4
620-427-1
108173-90-6
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
620-422-4
4097-36-3
Acute Tox. 3
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
620-410-9
4234-79-1
Acute Tox. 3; Acute Tox. 4
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
620-403-0
8003-05-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
620-400-4
12031-65-1
Carc. 1A; STOT RE 1; Skin Sens. 1
620-395-9
12737-30-3
Carc. 1A; STOT RE 1; Skin Sens. 1
620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
620-377-0
13067-93-1
Acute Tox. 3; STOT SE 1; Acute Tox. 4; Eye Irrit. 2
620-370-2
2703-37-9
Acute Tox. 2; Acute Tox. 1
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
620-365-5
9016-72-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
620-362-9
1918-18-9
Acute Tox. 4
620-359-2
8065-36-9
Acute Tox. 3
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
620-041-3
907204-31-3
Lact.
619-823-7
494793-67-8
Carc. 2
619-396-7
99129-21-2
Acute Tox. 4; Skin Sens. 1
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
619-377-3
98886-44-3
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
619-290-0
97780-06-8
Eye Irrit. 2
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
619-000-2
94125-34-5
Acute Tox. 4
618-541-1
9036-19-5
yes
618-392-2
9004-70-0
Expl. 1.1
618-344-0
9002-93-1
yes
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
618-004-1
87392-12-9
Skin Sens. 1
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
617-485-5
76714-88-0
Acute Tox. 4
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
617-356-3
82560-54-1
Repr. 2; Acute Tox. 3; Acute Tox. 4
617-258-0
81777-89-1
Acute Tox. 4
617-243-9
81591-81-3
Acute Tox. 4
617-219-8
81334-34-1
Eye Irrit. 2
617-100-0
8051-02-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
616-932-1
8011-63-0
Acute Tox. 4; Eye Dam. 1
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
616-699-6
79538-32-2
Acute Tox. 1; Acute Tox. 2
616-669-2
79241-46-6
Repr. 2
616-584-0
7803-57-8
yes
616-572-5
7790-84-3
yes
616-541-6
7789-12-0
yes
616-510-7
7782-63-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
616-477-9
7758-99-8
Acute Tox. 4; Eye Dam. 1
616-473-7
77536-68-6
Carc. 1A; STOT RE 1
616-472-1
77536-67-5
Carc. 1A; STOT RE 1
616-471-6
77536-66-4
Carc. 1A; STOT RE 1
616-379-6
76738-62-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
616-221-6
7541-49-3
Skin Irrit. 2
616-100-8
74499-35-7
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
615-135-6
70630-17-0
Acute Tox. 4; Eye Dam. 1
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
614-346-0
68157-60-8
Carc. 2
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
613-911-9
66230-04-4
Acute Tox. 3; STOT SE 1; STOT RE 2; Skin Sens. 1
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
611-802-0
591-34-4
Flam. Liq. 3
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
611-516-6
57369-32-1
Acute Tox. 4
611-341-5
55965-84-9
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
611-089-6
540-67-0
Flam. Gas 1; Press. Gas
610-700-3
51580-86-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
610-007-6
422556-08-9
Skin Sens. 1
609-346-2
37205-87-1
yes
608-879-8
335104-84-2
Repr. 2; STOT RE 2; Skin Sens. 1
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
608-492-4
3050-88-2
yes
608-055-8
27147-75-7;27459-10-5
yes
608-055-8
27147-75-7;27459-10-5
yes
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
607-955-8
2655-14-3
Acute Tox. 4
607-329-4
24151-93-7
Acute Tox. 4
606-640-2
2079-00-7
Acute Tox. 2
606-566-0
20487-40-5
Flam. Liq. 2
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
606-168-7
189278-12-4
Carc. 2
605-769-1
17606-31-4
Acute Tox. 4
605-752-9
175217-20-6
STOT RE 2
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
605-329-9
163515-14-8
Acute Tox. 4; Skin Sens. 1
605-127-0
158062-67-0
Acute Tox. 4
605-037-1
156052-68-5
Skin Sens. 1
605-015-1
155569-91-8
Acute Tox. 3; STOT SE 1; STOT RE 1; Eye Dam. 1
604-715-4
149979-41-9
Carc. 2; Repr. 2
604-712-8
149961-52-4
Carc. 2; Repr. 2; Acute Tox. 4
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
604-430-5
144651-06-9
STOT RE 2
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
604-395-6
14409-72-4
yes
604-351-6
143390-89-0
Carc. 2
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
604-314-4
142844-00-6
yes
604-291-0
142469-14-5
Skin Sens. 1
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
604-237-6
141517-21-7
Lact.; Skin Sens. 1
604-222-4
141112-29-0
Repr. 2
604-209-3
140923-17-7
Carc. 2
604-167-6
139968-49-3
Repr. 2; Lact.; STOT RE 2
604-105-8
139001-49-3
Carc. 2; Repr. 2; Skin Sens. 1
603-921-1
135410-20-7
Acute Tox. 4
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
603-804-5
134237-52-8
yes
603-802-4
134237-51-7
yes
603-801-9
134237-50-6
yes
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B
603-524-3
131860-33-8
Acute Tox. 3
603-520-1
131807-57-3
STOT RE 2
603-411-9
1303-96-4
Repr. 1B
yes
603-404-0
130328-20-0
Repr. 2; Skin Irrit. 2; Eye Dam. 1
603-146-9
126535-15-7
Carc. 2
603-038-1
125225-28-7
Repr. 1B; Acute Tox. 4; STOT RE 2
603-031-3
125116-23-6
Repr. 2; Acute Tox. 4
602-997-3
124495-18-7
Skin Sens. 1
602-929-2
123333-53-9
Expl. 1.3
602-927-1
123312-89-0
Carc. 2; Repr. 2
602-894-3
12280-03-4
Repr. 1B
602-782-4
122453-73-0
Acute Tox. 3; Acute Tox. 4
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
601-808-1
12179-04-3
Repr. 1B
yes
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
601-785-8
121552-61-2
Skin Sens. 1
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
601-585-0
119168-77-3
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1B
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
601-305-7
114311-32-9
Repr. 2
601-147-9
111988-49-9
Carc. 2; Repr. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
600-662-6
105512-06-9
Acute Tox. 4; STOT RE 2; Skin Sens. 1

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