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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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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
235-702-8
12578-12-0
yes
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
234-541-0
12008-41-2
Repr. 1B
yes
603-411-9
1303-96-4
Repr. 1B
yes
601-808-1
12179-04-3
Repr. 1B
yes
215-540-4
1330-43-4
Repr. 1B
yes
208-762-8
540-97-6
yes
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
yes
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
292-966-7
91031-62-8
yes
205-912-4
206-44-0
yes
500-036-1
25214-70-4
yes
300-298-5
93925-00-9
yes
200-842-0
75-12-7
Repr. 1B
yes
203-727-3
110-00-9
Flam. Liq. 1; Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2
yes
603-804-5
134237-52-8
yes
203-856-5
111-30-8
Acute Tox. 2; Acute Tox. 3; STOT SE 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1A
yes
218-165-4
2058-94-8
yes
206-803-4
376-06-7
yes
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gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
247-148-4
25637-99-4
Repr. 2; Lact.
yes
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
206-114-9
302-01-2
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
616-584-0
7803-57-8
yes
-
-
yes
-
-
yes
234-284-4
11066-49-2
yes
609-346-2
37205-87-1
yes
237-486-0
13814-96-5
yes
231-846-0
7758-97-6
Carc. 1B; Repr. 1A; STOT RE 2
yes
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
244-073-9
20837-86-9
yes
206-104-4
301-04-2
Repr. 1A; STOT RE 2
yes
236-542-1
13424-46-9
yes
233-245-9
10099-74-8
yes
229-335-2
6477-64-1
yes
232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
yes
215-267-0
1317-36-8
yes
234-853-7
12036-76-9
yes
231-100-4
7439-92-1
Repr. 1A; Lact.
yes
239-290-0
15245-44-0
yes
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
235-038-9
12060-00-3
yes
235-727-4
12626-81-2
yes
BLEIMETHANSULFONAT; LEAD (II) METHANESULFONATE; LEAD METHANE SULPHONATE; LEAD SALT FP
401-750-5
17570-76-2
Repr. 1A; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
yes
UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17
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di-, tri- and tetrachlorotetradecane EC / List no: 950-299-5 | CAS no: -
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
Tetradecane, chloro derivs. EC / List no: - | CAS no: 198840-65-2
799-971-8
-
yes
210-894-6
625-45-6
Repr. 1B; Acute Tox. 4; Skin Corr. 1B
yes
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
202-959-2
101-61-1
Carc. 1B
yes
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
201-182-6
79-16-3
Repr. 1B
yes
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
500-024-6
9016-45-9
yes
931-755-2
-
yes
931-756-8
-
yes
931-753-1
-
yes
931-754-7
-
yes
939-993-9
-
yes
-
-
yes
938-618-6
-
yes
932-998-7
-
yes
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
209-136-7
556-67-2
Repr. 2
yes
-
-
yes
215-235-6
1314-41-6
yes
237-560-2
13840-56-7
Repr. 1B
yes
250-339-5
30784-30-6
yes
201-280-9
80-46-6
yes
241-427-4
17404-66-9
yes
247-770-6
26543-97-5
yes
203-199-4
104-40-5
yes
287-196-3
85422-92-0
yes
307-202-0
97553-43-0
yes
276-745-2
72629-94-8
yes
235-067-7
12065-90-6
yes
256-418-0
49663-84-5
yes
603-902-8
13517-20-9
yes
600-611-8
10486-00-7
yes
600-419-4
10332-33-9
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
206-793-1
375-73-5
yes
206-587-1
355-46-4
yes
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
-
21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
201-581-5
85-01-8
yes
-
-
yes
616-100-8
74499-35-7
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
608-492-4
3050-88-2
yes
310-154-3
121158-58-5
yes
310-154-3
121158-58-5
yes
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
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Phenol, 4-isododecyl- EC / List no: 608-055-8 | CAS no: 27147-75-7
Phenol, 4-dodecyl, branched EC / List no: 640-104-9 | CAS no: 210555-94-5
Phenol, tetrapropylene- EC / List no: - | CAS no: 57427-55-1
[No public or meaningful name is available] EC / List no: - | CAS no: 27459-10-5
Phenol, dodecyl-, branched EC / List no: 310-154-3 | CAS no: 121158-58-5
Phenol, (tetrapropenyl) derivatives EC / List no: 616-100-8 | CAS no: 74499-35-7
799-972-3
-
yes
276-743-1
72624-02-3
yes
291-844-0
90481-04-2
yes
-
-
yes
-
57427-55-1
yes
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
618-541-1
9036-19-5
yes
266-578-3
67118-55-2
yes
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
231-906-6
7778-50-9
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
234-329-8
11103-86-9
yes
223-393-2
3871-99-6
yes
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
204-927-3
129-00-0
yes
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
915-270-3
-
yes
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
-
-
yes
939-460-0
1471311-26-8
yes
X4261
401-850-9
255881-94-8
yes
-
-
yes
-
-
yes
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Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 | CAS no: 3871-99-6
Ammonium perfluorohexane-1-sulphonate EC / List no: 269-511-6 | CAS no: 68259-08-5
N,N,N-triethylethanaminium tridecafluorohexane-1-sulfonate EC / List no: - | CAS no: 108427-55-0
-
-
yes
272-271-5
68784-75-8
yes
234-363-3
11120-22-2
yes
231-889-5
7775-11-3
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
616-541-6
7789-12-0
yes
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes
239-172-9
15120-21-5
yes
231-556-4
7632-04-4
yes
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
616-572-5
7790-84-3
yes
263-467-1
62229-08-7
yes
626-360-4
15244-35-6
yes
262-967-7
61788-32-7
yes
262-967-7
61788-32-7
yes
235-541-3
12267-73-1
Repr. 1B
yes
-
198840-65-2
yes
201-075-4
78-00-2
yes
235-380-9
12202-17-4
yes
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
206-203-2
307-55-1
yes
274-462-9
70225-16-0
yes
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
215-290-6
1319-46-6
yes
222-979-5
3687-31-8
yes
235-252-2
12141-20-7
yes
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
213-934-0
1067-53-4
Repr. 1B
yes
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Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
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
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
799-976-5
-
yes
247-759-6
26523-78-4
Skin Sens. 1
yes
238-253-6
14312-40-4
yes
246-677-8
25155-23-1
Repr. 1B
yes
936-037-2
-
yes
229-851-8
6786-83-0
yes
203-770-8
110-46-3
Flam. Liq. 2; Acute Tox. 4
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
430-460-1
133636-82-5
Skin Corr. 1B; Skin Sens. 1
419-620-1
-
Skin Sens. 1
432-360-3
105813-13-6
Acute Tox. 4; Skin Sens. 1
BRL 29226
406-030-4
105812-81-5
Acute Tox. 4; Eye Dam. 1
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
KELCOR; LIPOKEL; SEQUOL
425-230-2
16610-63-2
Skin Corr. 1B
256-032-2
42978-66-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
444-480-3
393517-29-8
Skin Irrit. 2
427-580-1
211299-54-6
Skin Irrit. 2
1418U90
418-530-1
79200-56-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
CP-84,203-4; DFX-5S
411-000-9
125224-62-6
Skin Sens. 1
P-NITROBENZYLESTER PGSO
412-670-5
54275-93-3
Resp. Sens. 1
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
SERTRALINE STEP 2
420-560-3
79617-97-3
Eye Dam. 1
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1
BLUE 10 25 964
407-240-9
159604-94-1
Skin Sens. 1
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
DWS
404-940-6
86608-70-0
Acute Tox. 4; Eye Dam. 1; STOT RE 2
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
420-370-0
6485-67-2
Eye Irrit. 2; Skin Sens. 1
UK-103,449-BV
427-100-0
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
433-820-6
118058-74-5
Eye Irrit. 2
4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1

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