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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 26 April 2024. Database contains 4821 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionyl fluoride
218-173-8
2062-98-8
yes
2,3,3-trimethylpentane
209-207-2
560-21-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3,4,6-tetrachlorophenol
200-402-8
58-90-2
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
2,3,4-trichlorobut-1-ene
219-397-9
2431-50-7
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,3,4-trimethylpentane
209-292-6
565-75-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3,5,6-tetrahydro-2-methylphthalic anhydride
255-853-3
42498-58-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
2,3,5-trimethylhydroquinone
211-838-3
700-13-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2,3,6-TBA (ISO); 2,3,6-trichlorobenzoic acid
200-026-4
50-31-7
Acute Tox. 4
2,3-dibromopropan-1-ol; 2,3-dibromo-1-propanol
202-480-9
96-13-9
Carc. 1B; Repr. 2; Acute Tox. 3; Acute Tox. 4
yes
2,3-dichloropropene; 2,3-dichloropropylene
201-153-8
78-88-6
Flam. Liq. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
2,3-dimethylbutane
201-193-6
79-29-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-dimethylhexane
209-547-1
584-94-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-dimethylpentane
209-280-0
565-59-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-dinitrophenol
200-628-7
66-56-8
Acute Tox. 3; STOT RE 2
2,3-dinitrotoluene
210-013-5
602-01-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,3-epoxypropan-1-ol; glycidol; oxiranemethanol
209-128-3
556-52-5
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,3-epoxypropyl acrylate; glycidyl acrylate
203-440-3
106-90-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2,3-epoxypropyl methacrylate; glycidyl methacrylate
203-441-9
106-91-2
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; STOT RE 1; Eye Dam. 1; Skin Corr. 1C; Skin Sens. 1
2,3-epoxypropyl o-tolyl ether
218-645-3
2210-79-9
Muta. 2; Skin Irrit. 2; Skin Sens. 1
2,3-epoxypropyltrimethylammonium chloride ... %; glycidyl trimethylammonium chloride ... %
221-221-0
3033-77-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2,3-xylenol
208-395-3
526-75-0
Acute Tox. 3; Skin Corr. 1B
2,4(or 2,5)-xylenol
276-245-4
71975-58-1
Acute Tox. 3; Skin Corr. 1B
2,4(or 2,6)-dinitrophenol
275-732-9
71629-74-8
Acute Tox. 3; STOT RE 2
2,4,4-trimethylhexamethylene-1,6-di-isocyanate
239-714-4
15646-96-5
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
2,4,4-trimethylpent-1-ene
203-486-4
107-39-1
Flam. Liq. 2
2,4,4-trimethylpentene
246-690-9
25167-70-8
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
2,4,5-T (ISO); 2,4,5-trichlorophenoxy acetic acid
202-273-3
93-76-5
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,4,5-trichlorophenol
202-467-8
95-95-4
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2,4,5-trimethylaniline
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane; metaldehyde
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
2,4,6-trichloro-1,3,5-triazine; cyanuric chloride
203-614-9
108-77-0
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2,4,6-trichlorophenol
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2,4,6-trimethyl-1,3,5-trioxane; paraldehyde
204-639-8
123-63-7
Flam. Liq. 3
2,4,6-trinitro-m-cresol
210-027-1
602-99-3
Expl. 1.1; Acute Tox. 4
2,4,6-trinitro-m-xylene
211-187-5
632-92-8
Expl. 1.1; Acute Tox. 4; STOT RE 2
2,4,6-trinitrophenol; picric acid
201-865-9
88-89-1
Expl. 1.1; Acute Tox. 3
2,4,6-trinitroresorcinol; styphnic acid
201-436-6
82-71-3
Expl. 1.1; Acute Tox. 4
2,4,6-trinitrotoluene; TNT
204-289-6
118-96-7
Expl. 1.1; Acute Tox. 3; STOT RE 2
2,4,6-tris(dimethylaminomethyl)phenol
202-013-9
90-72-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2,4-D (ISO); 2,4-dichlorophenoxyacetic acid
202-361-1
94-75-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1; Skin Sens. 1
2,4-DB (ISO); 4-(2,4-dichlorophenoxy)butyric acid
202-366-9
94-82-6
Acute Tox. 4
2,4-Di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol; UV-327
223-383-8
3864-99-1
yes
2,4-diamino-3,5-diethyltoluene; 2,4-diethyl-6-methyl-1,3-benzenediamine
218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,4-diaminoanisole sulphate
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
2,4-diaminoanisole; 4-methoxy-m-phenylenediamine
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
2,4-dichlorophenol
204-429-6
120-83-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
2,4-dimethylhexane
209-649-6
589-43-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dimethylpentan-3-one; di-isopropyl ketone
209-294-7
565-80-0
Flam. Liq. 2; Acute Tox. 4
2,4-dimethylpentane
203-548-0
108-08-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dinitroaniline
202-553-5
97-02-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
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