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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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1-BROM-3,4,5-TRIFLUORBENZOL; 1-BROMO-3,4,5-TRIFLUOROBENZENE
418-480-9
138526-69-9
Flam. Liq. 3; Carc. 2; Skin Irrit. 2; Eye Dam. 1
1-BROM-3,5-DIFLUORBENZOL; 1-BROMO-3,5-DIFLUOROBENZENE; BDFB
416-710-2
461-96-1
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
BROMIDE 182,780
422-850-5
148757-89-5
Skin Sens. 1
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
GM 102 E
411-370-1
82857-68-9
Acute Tox. 3; Eye Dam. 1
414-380-4
140681-55-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
421-080-7
161462-35-7
STOT RE 2
CHINOLONCARBONSÄURE 93-073; CP-70,335
413-760-7
93107-30-3
Repr. 2
O-NITROBENZALDEHYDDIMETHYLACETAL
423-830-9
20627-73-0
Skin Sens. 1
418-440-0
136997-71-2
Skin Sens. 1
SURFADONE LP-300 SURFACTANT
403-730-1
2687-96-9
Skin Corr. 1B; Skin Sens. 1
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
MEM
418-250-8
65756-41-4
Muta. 2
MEP
418-200-5
69227-51-6
Muta. 2
419-570-0
195006-58-7
Acute Tox. 4
418-330-2
162241-33-0
Expl. 1.1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
434-120-3
1380001-48-8
Skin Sens. 1
METHOXYISOPROPYLAMINE
422-550-4
37143-54-7
Flam. Liq. 2; Skin Corr. 1B; Acute Tox. 4
431-180-2
5271-27-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
424-160-1
139481-22-4
Acute Tox. 4
423-960-6
139756-01-7
Acute Tox. 4; STOT RE 2
N-N-OCTYLCAPROLACTAM; N-OCTYLCAPROLACTAME
420-040-6
59227-88-2
Skin Corr. 1B; Skin Sens. 1
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
ARCOSOLV PTB; ARCOSOLV(R) PTB
406-180-0
57018-52-7
Flam. Liq. 3; Eye Dam. 1
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
432-840-2
220926-97-6
Acute Tox. 4
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
BLEU DISPERSE 370; BLEU DISPERSO 370; BLEU LIP 6994; C.I. DISPERSE BLUE 370; DISPERS BLAU 370; DISPERSE BLUE 370
403-010-7
106359-94-8
Skin Sens. 1
BLEU 1047679; BLUE 1047679
405-200-5
104366-25-8
Skin Sens. 1
BLEU 1044098; BLUE 1044098
405-190-2
122371-93-1
Skin Sens. 1
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
TG-SA
411-570-9
41481-66-7
Skin Sens. 1
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
KHUSINIL
422-580-8
75490-39-0
Acute Tox. 4
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
DMBA
424-090-1
10097-02-6
Eye Dam. 1
430-580-4
-
Skin Irrit. 2
PERMACHEM N21
412-380-9
69094-18-4
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Skin Sens. 1
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
METHYL ETHYL THIAZOLIDINE
404-500-3
694-64-4
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,3,4,5-TETRACHLORBENZOYLCHLORID
406-760-3
42221-52-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
Skin Irrit. 2; Eye Dam. 1
CIN 10096132; MTI
407-630-9
82633-79-2
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
DCTFMP
410-340-5
69045-84-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
424-060-6
6364-17-6
Acute Tox. 4; STOT RE 2; Skin Sens. 1
CLARITONE
422-520-0
74338-72-0
Skin Irrit. 2
T3P
422-210-5
68957-94-8
Skin Corr. 1B
423-560-1
161717-32-4
Skin Sens. 1
ESACURE TZT 100
403-150-9
954-16-5
Acute Tox. 4; Eye Irrit. 2
429-610-9
1030366-98-3
Acute Tox. 4; Eye Dam. 1
429-600-4
1026988-42-0
Acute Tox. 4; Eye Dam. 1
BASISCH GELB 8511
407-010-8
118208-02-9
Acute Tox. 4; Eye Dam. 1
CYCLOWOOD
405-340-7
13019-04-0
Skin Irrit. 2
424-870-1
27624-67-5
Expl. 1.1; Eye Dam. 1
DAMP
410-330-0
54236-98-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,4-DICHLORO-3-ETHYL-6-NITROPHENOL
420-740-1
99817-36-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
PM 9879
401-060-4
121518-45-4
Skin Corr. 1B
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-310-8
57987-55-0
Eye Dam. 1
UK-51,060-01
412-390-3
86386-75-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
434-820-9
106461-41-0
STOT RE 2
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
LYRISAL
405-690-0
114119-97-0
Skin Irrit. 2; Skin Sens. 1
MR-8A; MR-N2; NBDI
411-280-2
161973-12-2
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
DIAZO W 6623-TS
413-290-2
93672-52-7
Self-react. C; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
430-170-5
114625-74-0
Acute Tox. 4
HR-11
419-770-8
136122-15-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
424-660-8
-
STOT RE 2; Eye Dam. 1; Skin Sens. 1
440-030-5
338735-71-0
Skin Irrit. 2; Eye Dam. 1
429-460-4
7078-98-0
Skin Sens. 1
444-250-2
144111-81-9
Self-react. C
VIOLETT MIP 3250
424-120-1
174514-06-8
Eye Dam. 1
AZOGELB
421-430-9
28365-08-4
Acute Tox. 4; STOT RE 2
FPB 800
427-400-1
140623-89-8
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
T 1049
403-350-6
17742-69-7
Acute Tox. 3
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
PIGMENT ADDITIV AC; PIGMENTADDITIV AC
404-230-6
164578-11-4
Skin Sens. 1
FAT 40'398; FAT 40'398/E
411-100-2
136213-73-5
STOT RE 2; Skin Sens. 1
RO 1082
411-260-3
117907-43-4
Eye Dam. 1; Skin Sens. 1
METHYLGELB
408-090-7
100418-33-5
Acute Tox. 4; Skin Sens. 1
2S4TBP
421-740-4
51390-14-8
Skin Corr. 1B
426-480-5
63562-33-4
Skin Sens. 1
TAA
407-850-5
89544-40-1
Acute Tox. 4; Eye Dam. 1
EPO
411-210-0
89544-48-9
Skin Irrit. 2; Skin Sens. 1
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
31 AC-HCL
410-620-7
119154-86-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
GUAIACOL-O-ETHYLBROMIDE
402-010-4
4463-59-6
Acute Tox. 4
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
425-050-4
10217-34-2
Skin Sens. 1
M-TMI
402-440-2
2094-99-7
Acute Tox. 2; Skin Corr. 1B; STOT RE 2; Resp. Sens. 1; Skin Sens. 1

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