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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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BMS 187266-02; S-TIPAC
430-300-0
76932-17-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
430-280-3
844491-96-9
Skin Sens. 1
430-250-1
406-58-6
Flam. Liq. 2
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
430-220-6
141942-85-0
Eye Irrit. 2
430-200-7
-
Eye Dam. 1
SP 7077
430-180-1
-
Skin Irrit. 2
430-170-5
114625-74-0
Acute Tox. 4
430-100-3
86978-24-7
Acute Tox. 4
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
430-050-2
-
Skin Sens. 1
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
429-990-6
-
Eye Dam. 1; Skin Sens. 1
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
429-900-5
82356-51-2
Skin Sens. 1
429-860-9
86803-90-9
Skin Sens. 1
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
GUANIDINIUMBENZOAT
429-820-0
26739-54-8
Acute Tox. 4
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
429-710-2
-
Self-react. D; Acute Tox. 4
429-680-0
122665-86-5
Skin Sens. 1
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
DOWFAX (R) DRY HYDROTROPE POWDER
429-650-7
147732-60-3
Eye Irrit. 2
429-640-2
52870-46-9
Eye Irrit. 2
429-620-3
110028-14-3
Skin Irrit. 2; Skin Sens. 1
429-610-9
1030366-98-3
Acute Tox. 4; Eye Dam. 1
429-600-4
1026988-42-0
Acute Tox. 4; Eye Dam. 1
429-590-1
-
Skin Sens. 1
429-570-2
213990-58-0
Skin Sens. 1
429-560-8
4274-38-8
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
429-460-4
7078-98-0
Skin Sens. 1
429-440-5
-
Eye Dam. 1
429-430-0
444-14-4
Acute Tox. 4
429-400-7
199327-61-2
Repr. 1B
429-380-1
133336-92-2
Skin Sens. 1
429-370-5
220410-74-2
Acute Tox. 4
429-340-1
186295-11-4
Acute Tox. 4; Eye Dam. 1
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
429-310-8
57987-55-0
Eye Dam. 1
PYRAZOL P5; PYRAZOLE DHE
429-300-3
155601-30-2
Eye Dam. 1; Skin Sens. 1
429-290-0
3380-30-1
Eye Dam. 1
429-270-1
136210-30-5
Skin Sens. 1
429-240-8
212652-59-0
Eye Dam. 1
429-230-3
371921-41-4
Eye Dam. 1
429-220-9
132584-17-9
Skin Sens. 1
429-180-2
157362-53-3
Skin Sens. 1
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
429-120-5
208535-04-0
Eye Dam. 1
2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
429-040-0
272460-97-6
Eye Dam. 1
CP-328,914
429-030-6
57999-49-2
Skin Sens. 1
429-020-1
204254-96-6
STOT RE 2; Skin Sens. 1
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
428-790-6
72963-72-5
Carc. 2; Acute Tox. 4; STOT SE 2
428-700-5
1873-90-1
Acute Tox. 4
428-690-2
1668-86-6
Acute Tox. 4; Eye Irrit. 2
428-650-4
153719-23-4
Repr. 2; Acute Tox. 4
428-630-5
-
Skin Sens. 1
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
428-400-4
-
Eye Dam. 1
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
428-340-9
238088-70-5
Skin Irrit. 2
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
428-320-1
71308-16-2
Acute Tox. 4; Skin Sens. 1
BM 96.0258.HCL
428-290-8
120606-08-8
Acute Tox. 4; Eye Dam. 1
428-260-4
-
Eye Dam. 1
428-230-0
79568-06-2
STOT RE 2
428-100-3
94239-04-0
Flam. Liq. 3; Acute Tox. 4
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
428-050-2
-
Skin Sens. 1
428-040-8
138261-41-3
Acute Tox. 3
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
428-020-9
6195-20-6
Skin Sens. 1
CP-166,221
428-010-4
82413-20-5
Carc. 2; Repr. 1B; Skin Sens. 1
427-930-3
250639-69-1
Skin Sens. 1
427-880-2
90357-53-2
STOT RE 2
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
427-850-9
202667-43-4
Skin Sens. 1
427-780-9
114565-70-7
Acute Tox. 4; Eye Dam. 1
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
427-740-0
-
Eye Dam. 1; Skin Sens. 1
427-730-6
202420-04-0
Skin Corr. 1B
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
ECPA
427-630-2
99469-99-5
Eye Dam. 1
427-580-1
211299-54-6
Skin Irrit. 2
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-470-3
137864-22-3
Acute Tox. 4; Skin Sens. 1
427-450-4
152630-47-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
FPB 800
427-400-1
140623-89-8
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
427-370-1
164288-56-6
Eye Dam. 1
4-(4-BUTYLCYCLOHEXYL)-ACETOPHENON
427-320-7
83626-30-6
Skin Sens. 1
427-310-2
180850-95-7
Eye Dam. 1
427-300-8
79463-77-7
Eye Dam. 1
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
427-230-8
5571-36-8
Repr. 1B; STOT RE 2
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
427-140-9
-
Carc. 2
427-110-5
948991-29-5
Acute Tox. 4; STOT RE 2
UK-103,449-BV
427-100-0
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
427-090-8
116044-44-1
Skin Sens. 1
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
427-040-5
-
Skin Corr. 1B
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
426-900-7
203118-12-1
STOT SE 3
426-890-4
77341-67-4
Eye Dam. 1
426-860-0
191877-09-5
Eye Dam. 1
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
426-840-1
-
Eye Dam. 1
4'-(4-PENTYLCYCLOHEXYL)ACETOPHENONE
426-830-7
78531-59-6
Skin Sens. 1
4'-(4-HEPTYLCYCLOHEXYL)ACETOPHENONE
426-820-2
78531-60-9
Skin Sens. 1
5-(3-PYRIDYL)-TETRAZOL
426-810-8
3250-74-6
Eye Dam. 1
DAMA
426-790-0
162208-27-7
Acute Tox. 4; STOT RE 2; Skin Sens. 1
426-750-2
151860-15-0
Skin Sens. 1
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1
426-730-3
123439-82-7
Acute Tox. 4; Eye Dam. 1
426-620-5
619297-89-1
Eye Dam. 1
426-590-3
187412-41-5
Skin Sens. 1
426-540-0
2973-59-3
Skin Sens. 1
426-530-6
-
Skin Irrit. 2
426-520-1
71420-85-4
Skin Sens. 1
426-480-5
63562-33-4
Skin Sens. 1
426-470-0
214897-29-7
Skin Sens. 1
4-(4-ETHYLCYCLOHEXYL)-ACETOPHENON
426-460-6
260415-81-4
Skin Sens. 1
426-400-9
170222-39-6
Skin Sens. 1
426-370-7
1017183-70-8
Skin Corr. 1A; Acute Tox. 4
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
PYRIDYLACROLEIN
426-330-9
177964-68-0
Eye Irrit. 2; Skin Sens. 1
426-300-5
-
Eye Dam. 1
CLEARFRAC J508B
426-210-6
120086-58-0
Skin Corr. 1B
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
426-150-0
121246-28-4
Skin Sens. 1
CAMONAL
426-130-1
166301-21-9
Skin Irrit. 2
426-110-2
98377-35-6
Skin Sens. 1
9,10-ANTHRACENEDIOL, DISODIUM SALT
426-030-8
46492-07-3
Skin Corr. 1A
426-020-3
51229-78-8
Flam. Sol. 2; Repr. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
SEL DE VILSMEIER-HAACK
425-970-6
3724-43-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1A
425-930-8
151213-39-7
Skin Corr. 1B; Acute Tox. 4; STOT RE 2
425-910-9
32480-08-3
Skin Irrit. 2
425-870-2
19450-38-5
Skin Sens. 1
425-860-8
125971-57-5
Skin Sens. 1
425-830-4
-
Eye Dam. 1
UK-48,340
425-820-1
88150-42-9
Acute Tox. 3; STOT RE 2; Eye Dam. 1
CHLOROFORMIATE DE CHLORO 3 PROPYLE
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
425-760-4
64137-52-6
Eye Dam. 1
425-740-5
-
Eye Dam. 1
425-730-0
51178-75-7
Skin Sens. 1
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
425-530-3
98769-75-6
Acute Tox. 4; Eye Dam. 1
425-520-9
197179-61-6
Eye Dam. 1
425-460-3
1379676-84-2
Skin Sens. 1
425-450-9
294-90-6
Skin Corr. 1B; Acute Tox. 4
425-430-1
6746-94-7
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
425-380-9
7397-46-8
Pyr. Liq. 1; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
425-370-4
93957-50-7
Skin Sens. 1
425-300-2
186450-73-7
Skin Sens. 1
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
425-240-7
-
Eye Dam. 1
KELCOR; LIPOKEL; SEQUOL
425-230-2
16610-63-2
Skin Corr. 1B
425-210-3
169939-84-8
Skin Sens. 1
425-190-6
119916-05-1
STOT RE 2
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
425-080-8
104860-26-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
425-050-4
10217-34-2
Skin Sens. 1
425-030-5
159939-85-2
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
424-980-8
22288-41-1
Flam. Liq. 2; Org. Perox. D; Skin Irrit. 2; Skin Sens. 1
424-870-1
27624-67-5
Expl. 1.1; Eye Dam. 1
424-850-0
189702-72-5
Eye Dam. 1
424-740-2
138271-16-6
Acute Tox. 4; Eye Dam. 1
424-710-9
156126-48-6
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
424-660-8
-
STOT RE 2; Eye Dam. 1; Skin Sens. 1
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
424-530-0
93076-03-0
Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
424-510-1
-
Eye Dam. 1
424-460-0
283167-56-6
Acute Tox. 4; Skin Sens. 1
424-390-0
93280-40-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1
424-380-6
43057-68-7
Acute Tox. 4; STOT RE 2
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
MARINE REN 600
424-320-9
180778-23-8
Eye Dam. 1
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
424-290-7
188070-47-5
Skin Sens. 1
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1

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