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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 srpnja 2024. Database contains 4821 unique substances/entries.
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IRB
418-070-1
141714-54-7
Skin Sens. 1
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
417-970-1
1379932-74-7
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1
ATRAC 869
417-960-5
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
FLUFENOXURON
417-680-3
101463-69-8
Lact.
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
NAVY DER 7850
417-640-5
161935-19-9
Eye Dam. 1; Skin Sens. 1
REACTIVE NAVY DER 7678
417-610-1
155522-09-1
Skin Sens. 1
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
EBO
417-540-1
-
Eye Dam. 1
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
PDN 2287
417-450-2
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
FRESCOLAT MPC
417-420-9
156324-82-2
Eye Irrit. 2
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
417-360-3
1379678-84-8
Acute Tox. 4; Skin Irrit. 2
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
FC4010
417-290-3
147086-81-5
Acute Tox. 4
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
DAISO CCS-1S-E; S-GLYTO
417-210-7
70987-78-9
Carc. 1B; Muta. 2; Eye Dam. 1; Skin Sens. 1
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
417-130-2
1379689-21-0
Eye Dam. 1
TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
417-050-8
151006-58-5
Acute Tox. 4
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 2
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
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
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
B8510-020; CHLORMETHYLPYRIDIN; CHLORMETHYLPYRIDINE; CHLOROMETHYLPYRIDINE
416-440-5
72830-09-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
416-360-0
162221-28-5
Skin Sens. 1
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
DISPERSE RED CLA 282
416-240-8
155522-12-6
Skin Sens. 1
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
SQ 28,355; SQ 28355
416-050-5
87460-09-1
Eye Dam. 1
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
GABAPENTINE ETHYL ESTER; PD 137016
415-970-4
133481-10-4
Acute Tox. 4; STOT RE 2
SP 7053
415-930-6
-
Repr. 2; Skin Sens. 1
FC-102B; M-3218
415-910-7
152828-25-6
Skin Sens. 1
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
P2-800; P2-935LV
415-870-0
-
Skin Sens. 1
LOVASTATIN FREE ACID
415-840-7
-
Skin Sens. 1
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
7-PACA
415-750-8
106447-44-3
Skin Sens. 1
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
SB-201999
415-680-8
143468-96-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
GR138766X
415-670-3
78850-37-0
Eye Dam. 1
DOXAZOSIN 4; DOXAZOSIN STEP 4
415-660-9
70918-74-0
Acute Tox. 3; STOT RE 2
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
CA 946 A
415-580-4
130841-23-5
Acute Tox. 4; Skin Sens. 1
BRL 44742
415-550-0
109887-53-8
Acute Tox. 4; Eye Dam. 1
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
AZO MONOCHLOROTRIAZINYL REACTIVE DYE; PROCION RED PX-6B COLOUR; SUBSTANCE S161057
415-400-4
148878-22-2
Eye Dam. 1; Skin Sens. 1
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
COLUMBIADUNKELBLAU R
415-350-3
-
Eye Dam. 1
BIS TRIFLUOROMETHANE SULFONIMIDE LITHIUM; FLUORAD BRAND LITHIUM TRIFLUOROMETHANESULPHONIMIDE HQ-115
415-300-0
90076-65-6
Acute Tox. 3; STOT RE 2; Skin Corr. 1B
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
PARMANYL
415-220-6
142653-61-0
Acute Tox. 3; Acute Tox. 4
MCP-304
415-210-1
160236-81-7
Acute Tox. 4; Eye Dam. 1
MS6119
415-190-4
-
Skin Sens. 1
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 1
PAYLEAN; RACTOPAMINE HYDROCHLORIDE
415-170-5
90274-24-1;99095-19-9
Acute Tox. 4; Skin Sens. 1
PAYLEAN; RACTOPAMINE HYDROCHLORIDE
415-170-5
90274-24-1;99095-19-9
Acute Tox. 4; Skin Sens. 1
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
LAMBDA-CYHALOTHRIN
415-130-7
91465-08-6
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
R-THP
415-110-8
54417-53-7
Acute Tox. 4
JAUNE REACTIF MUB 151
415-100-3
149850-29-3
Skin Sens. 1
DS 100
415-060-7
1379678-87-1
Eye Dam. 1; Skin Sens. 1
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
TRUSOPT INTERMEDIATE, L-686,771
415-030-3
120298-38-6
Skin Sens. 1
CC14837; SKF 106224
414-990-0
302-97-6
Repr. 2
PLR-22; XC95-A0638
414-960-7
53863-99-3
Acute Tox. 4
414-920-9
60658-04-0
Acute Tox. 3; STOT RE 1; Skin Sens. 1
414-910-4
-
Eye Dam. 1; Skin Sens. 1
VIKOFLEX 9080
414-890-7
71302-79-9
Skin Sens. 1
HNF; HYDRAZINIUM NITROFORMATE
414-850-9
4682-01-3
Expl. 1.1; Self-react. A; Carc. 1B; Acute Tox. 3; Skin Sens. 1
A-88820.605
414-810-0
-
STOT RE 2; Eye Dam. 1
A-87463.0
414-800-6
154212-60-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
T-69
414-770-4
140698-96-0
Self-react. C; Carc. 2
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
RED MDO 358
414-620-8
-
Eye Dam. 1; Skin Sens. 1
CZ-AMIDE; PTH-TETRAHYDROAMIDE; TETRAHYDROAMIDE (THA)
414-600-9
149182-72-9
Acute Tox. 4
SUBSTANCE S44176
414-570-7
18759-96-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Z-19
414-520-4
-
Skin Irrit. 2; Eye Dam. 1
414-470-3
95885-13-5
Acute Tox. 4
414-460-9
105726-67-8
Acute Tox. 4
CA 875 B
414-450-4
88805-65-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
SPE 93279
414-420-0
-
Eye Dam. 1
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
414-380-4
140681-55-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
414-340-6
-
Flam. Liq. 3; Acute Tox. 4; STOT SE 2; Eye Dam. 1; Skin Sens. 1
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
RO 1173
414-270-6
41959-35-7
Acute Tox. 4
ACID RED FC 70013
414-250-7
149564-66-9
Acute Tox. 4; Eye Dam. 1
PRODUKT 1096
414-230-8
-
Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
UTMS
414-180-7
10218-17-4
Acute Tox. 4; Skin Irrit. 2
BROWN JR 543
414-150-3
-
Skin Sens. 1
TRILON(R) ES 9910
414-130-4
119710-96-2
Acute Tox. 4
ORASOL BLAU 761B
414-110-5
1379678-96-2
Eye Dam. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
MAT 9460
414-080-3
117291-73-3
Acute Tox. 4
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
REACTIVE BLUE FC 60866
414-040-5
149530-93-8
Acute Tox. 4; Skin Sens. 1
AZA-KRONE-TETRATOSYLAT
414-030-0
52667-88-6
Skin Sens. 1
REACTIVE ORANGE TZ 3931
413-990-8
149850-31-7
Skin Sens. 1
VECTOMER E2200
413-930-0
130066-57-8
Skin Sens. 1
LUPEROX 610-E-35; LUPEROX 610-E-50; LUPEROX 610-EN-50; LUPEROX 610-M-50; LUPERSOL 610; LUPERSOL 610-M-50
413-910-1
1467668-33-2
Org. Perox. C; Flam. Liq. 3; Skin Irrit. 2
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
INDULIN MQK-1M
413-770-1
-
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
CHINOLONCARBONSÄURE 93-073; CP-70,335
413-760-7
93107-30-3
Repr. 2
413-740-8
1132-95-2
Skin Corr. 1B
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
DABCO X-412
413-670-8
103969-79-5
Eye Irrit. 2; Skin Sens. 1
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
-
STOT RE 2
LICHTSCHUTZMITTEL 1736
413-610-0
124172-53-8
Eye Irrit. 2
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
H112339
413-550-5
-
Skin Irrit. 2; Eye Dam. 1
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
-
Skin Irrit. 2; Eye Dam. 1
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
DAM 520
413-440-7
112006-75-4
Skin Sens. 1
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
RAPICURE CHVE
413-370-7
17351-75-6
Skin Sens. 1
DUPLOSAN-DP-MAGNESIUM
413-360-2
164058-21-3
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
DUPLOSAN-DP-NATRIUM; DUPOLSON-DP-NATRIUM
413-340-3
119299-10-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
DIAZO W 6623-TS
413-290-2
93672-52-7
Self-react. C; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
CHLORGELB; HC YELLOW 12
413-280-8
59320-13-7
Acute Tox. 4
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
LUCHEM HA-R 100; LUPERSOL HA-R 100
413-230-5
122035-71-6
Eye Dam. 1; Skin Sens. 1
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
DE 3
413-140-6
3459-83-4
Flam. Liq. 3
CARBODIM
413-120-7
107144-30-9
Acute Tox. 4
2-PHENYLETHYLISOCYANAT; 2-PHENYLETHYLISOCYANATE; PHENYL ETHYL ISOCYANATE
413-080-0
1943-82-4
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
FAT 40'489
413-040-2
149850-30-6
Skin Sens. 1
2-ADPS
413-030-8
1134-94-7
Skin Sens. 1
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
PROCION BRILLIANT ORANGE H-EXL; S156745
412-960-1
148878-21-1
Eye Dam. 1; Skin Sens. 1
PROCION YELLOW PX-R; S154357; SUBSTANCE S154357
412-940-2
148878-18-6
Skin Sens. 1
DIETHANOLAMIN-TRITOSYLAT
412-920-3
16695-22-0
Skin Sens. 1
BETA-METHOXYACRYLSÄURE METHYLESTER
412-900-4
5788-17-0
Skin Sens. 1
2-CHLOR-4-TOLUOLSULFONYLCHLORID
412-890-1
42413-03-6
Skin Corr. 1B; Skin Sens. 1
1,1-DIMETHYLETHOXY-CARBONYL-METHYLEN-TRIPHENYLPHOSPHORAN; DMY; PHOSPHORANE
412-880-7
35000-38-5
Acute Tox. 3; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 2
ADDITIV 104
412-780-3
1380226-46-9
Skin Irrit. 2; Skin Sens. 1
NATRIUMMETAWOLFRAMAT
412-770-9
12141-67-2
Acute Tox. 4; Eye Dam. 1
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
GOLPANOL APC
412-740-5
25965-81-5
Acute Tox. 4; Skin Sens. 1
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
P-NITROBENZYLESTER PGSO
412-670-5
54275-93-3
Resp. Sens. 1
PRIAZUL LAUROYL LACTYLATE; PRICARE LAURYL LACTYLATE (1:1.5)
412-590-0
58856-63-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PERKALINK 900
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
ET 344 SP
412-540-8
22471-55-2
Skin Irrit. 2
YELLOW DO 2286
412-530-3
157627-98-0
Eye Dam. 1; Skin Sens. 1
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
OXAMITOL
412-510-4
135043-64-0
Acute Tox. 4; Skin Sens. 1
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
L (-) CHLOROPROPIONATE DE METHYLE; S (-) CHLOROPROPIONATE DE METHYLE
412-470-8
73246-45-4
Flam. Liq. 3; STOT RE 2; Eye Irrit. 2
NEOCASPIRENE
412-460-3
89079-92-5
Skin Irrit. 2
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
UK-51,060-01
412-390-3
86386-75-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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
NSGBB; YELLOW BROWN E-GLN
412-320-1
31361-99-6
Eye Dam. 1
AMINOETHER
412-310-7
37866-45-8
Skin Sens. 1

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