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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
611-516-6
57369-32-1
Acute Tox. 4
610-007-6
422556-08-9
Skin Sens. 1
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
602-997-3
124495-18-7
Skin Sens. 1
201-435-0
82-68-8
Skin Sens. 1
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; 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
A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.
270-088-5
68410-71-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.
270-349-3
68425-35-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
-
Skin Sens. 1
DESBIMID
401-970-1
-
Skin Sens. 1
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
C.I. DIRECT YELLOW 166; DIRECT YELLOW 166; GIALLO DIRETTO 166; JAUNE DIRECT 166; MONOAZO YELLOW MA 2822
403-410-1
114565-65-0
Skin Sens. 1
KAYARAD R-825
405-360-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ADINE CP 31
401-740-0
-
Acute Tox. 4
915-270-3
-
yes
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
PK 323
401-940-8
-
Acute Tox. 4; Eye Irrit. 2
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1
X 3761
400-930-0
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PROJET 780 NP; SUBSTANCE SC101756
407-700-9
101408-30-4
Skin Sens. 1
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
BROWN JR 543
414-150-3
-
Skin Sens. 1
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
MARLOTHERM L
405-470-4
73807-39-3
Skin Irrit. 2
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
SUBSTANCE S166075
424-270-8
-
Eye Dam. 1
UNISOL S
405-760-0
-
Eye Dam. 1; Skin Sens. 1
EMULGATOR SWA; EMULVIN SWA
406-325-8
-
Acute Tox. 4
430-200-7
-
Eye Dam. 1
ETHOXYLATED POLYESTER RESIN
405-960-8
-
Skin Sens. 1
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
MPA
402-090-0
87025-52-3
Skin Corr. 1B

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