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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
ARGOLD; CINMETHYLIN; WL 95481
402-410-9
87818-31-3
Acute Tox. 4
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
289-339-5
87741-01-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
421-310-6
87691-88-1
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
688-331-2
874967-67-6
Carc. 2
SQ 28,355; SQ 28355
416-050-5
87460-09-1
Eye Dam. 1
618-004-1
87392-12-9
Skin Sens. 1
442-860-3
87333-22-0
Skin Sens. 1
212-836-5
873-32-5
Acute Tox. 4; Eye Irrit. 2
HALOXYFOP ETHOXYETHYL EST
402-560-5
87237-48-7
Acute Tox. 4
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
438-670-5
87199-17-5
Skin Sens. 1
CINEOLE ALCOHOL
402-470-6
87172-89-2
Acute Tox. 4; Eye Dam. 1
MPA
402-090-0
87025-52-3
Skin Corr. 1B
201-782-8
87-90-1
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
430-100-3
86978-24-7
Acute Tox. 4
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
429-860-9
86803-90-9
Skin Sens. 1
212-782-2
868-77-9
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
212-758-1
867-27-6
Acute Tox. 3
DWS
404-940-6
86608-70-0
Acute Tox. 4; Eye Dam. 1; STOT RE 2
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1
212-737-7
865-34-9
Self-heat. 1; Skin Corr. 1B
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
UK-51,060-01
412-390-3
86386-75-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30°C to 260°C (86°F to 500°F).
289-220-8
86290-81-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
201-706-3
86-88-4
Acute Tox. 2; Carc. 2
201-676-1
86-50-0
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
ALKYL ISOCYANATE SILANE SCD 617
402-290-8
85702-90-5
Flam. Liq. 3; Resp. Sens. 1; Skin Sens. 1
BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046
400-510-7
85665-98-1
Eye Dam. 1; Skin Sens. 1
C.I. REACTIVE RED 220; CIBACRON-RED F-2G; CIBACRON-ROT F-2G; REACTIVE RED 220; ROSSO REATTIVO 220; ROUGE REACTIF 220
400-790-0
85665-97-0
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
BRUN REACTIF 45; BRUNO REATTIVO 45; C.I. REACTIVE BROWN 45; CIBACROM BROWN 1347; CIBACRON BROWN 1347; REACTIVE BRAUN 45
401-650-1
85665-96-9
Skin Sens. 1
PACIFIED REACTIVE BLACK 31
423-940-7
85585-91-7
Eye Dam. 1
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-504-6
85536-22-7
yes
287-502-5
85536-20-5
Carc. 1B; Muta. 1B
287-500-4
85536-19-2
Carc. 1B; Muta. 1B
287-498-5
85536-17-0
Carc. 1B; Muta. 1B
287-477-0
85535-85-9
Lact.
yes
287-476-5
85535-84-8
Carc. 2
yes
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
287-471-8
85508-46-9
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
287-469-7
85508-44-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-468-1
85508-43-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-196-3
85422-92-0
yes
286-946-7
85407-90-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
-
852541-30-1
yes
-
852541-25-4
yes
-
852541-21-0
yes
701-454-9
852403-68-0
Repr. 2; Lact.; STOT RE 2
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
A complex combination of hydrocarbons obtained by hydrodesulfurization of heavy coker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range C18 to C44 and boiling in the range of approximately 304°C to 548°C (579°F to 1018° F). Likely to contain 5% or more of 4- to 6- membered condensed ring aromatic hydrocarbons.
285-555-9
85117-03-9
Carc. 1B
A complex combination of hydrocarbons obtained from the distillation of a petroleum fraction. It consists predominantly of alkanes and cycloalkanes boiling in the range of approximately minus 20°C to 190°C (-4°F to 374°F).
285-512-4
85116-61-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by fractionation of hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 to C11 and boiling in the range of approximately 23°C to 195°C (73°F to 383°F).
285-511-9
85116-60-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66°C to 121°C (151°F to 250°F).
285-510-3
85116-59-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of alkylbenzenes obtained by the catalytic reforming of petroleum naphtha. It consists predominantly of alkylbenzenes having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 160°C to 180°C (320°F to 356°F).
285-509-8
85116-58-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by fractionation from catalytically reformed hydrodesulfurized naphtha. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 to C13 and boiling in the range of approximately 98°C to 218°C (208°F to 424°F).
285-508-2
85116-57-0
Asp. Tox. 1
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons predominantly in the range of C8 to C16 and boiling in the range of approximately 120°C to 283°C (284°F to 541°F).
285-507-7
85116-55-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to C25 and boiling in the range of approximately 205° C to 400°C (401°F to 752°F).
285-505-6
85116-53-6
Carc. 1B
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
285-195-2
85049-26-9
yes
A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.
285-098-5
85029-74-9
Carc. 1B
The complex combination of hydrocarbons obtained from prefractionation (continuous distillation) of coke oven light oil. It consists predominantly of naphthalene, coumarone and indene and boils above 148°C (298°F).
285-076-5
85029-51-2
Carc. 1B; Muta. 1B
201-622-7
85-68-7
Repr. 1B
yes
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
201-599-3
85-34-7
Acute Tox. 4
201-581-5
85-01-8
yes
201-579-4
85-00-7
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
The extract oil boiling in the range of approximately 220°C to 265°C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.
284-901-6
84989-12-8
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from coal tar. It consists of aromatic and polycyclic hydrocarbons, primarily fluorene and acenaphthene.
284-900-0
84989-11-7
Carc. 1B
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.
284-899-7
84989-10-6
Carc. 1B
A complex combination of hydrocarbons obtained by crystallization of naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes and phenolic compounds.
284-898-1
84989-09-3
Carc. 1B; Muta. 1B
The fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distillation of low-temperature coal tar acids.
284-896-0
84989-07-1
Carc. 1B; Muta. 1B
The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-895-5
84989-06-0
Carc. 1B; Muta. 1B
The fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225°C to 320°C (437°F to 608°F). Composed primarily of polyalkylphenols.
284-893-4
84989-05-9
Carc. 1B; Muta. 1B
The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-892-9
84989-04-8
Carc. 1B; Muta. 1B
The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-891-3
84989-03-7
Carc. 1B; Muta. 1B
The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700°C (1292°F)) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols.
284-881-9
84988-93-2
Carc. 1B; Muta. 1B
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-349-6
84852-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1

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