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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 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
4-Heptylphenol
217-862-0
1987-50-4
yes
4-Heptylphenol, branched and linear
-
-
yes
4-hexadecyl-1-phenylpyrazolidin-3-one
430-840-7
202483-63-4
Skin Sens. 1
4-hydroxy-3-(3-(4'-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin; brodifacoum
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
4-hydroxy-4-methylpentan-2-one; diacetone alcohol
204-626-7
123-42-2
Eye Irrit. 2
4-hydroxy-7-(2-aminoethyl)-1,3-benzothiazol-2(3H)-one hydrochloride
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
4-isocyanatosulphonyltoluene; tosyl isocyanate
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
4-Isododecylphenol;Phenol, 4-isododecyl
608-055-8
27147-75-7;27459-10-5
yes
4-Isododecylphenol;Phenol, 4-isododecyl
608-055-8
27147-75-7;27459-10-5
yes
4-mesyl-2-nitrotoluene
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
4-methoxy-4-methylpentan-2-one
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
4-methoxy-N,6-dimethyl-1,3,5- triazin-2-ylamine
2-METHOXY-4-METHYL-6-METHYLAMINO-1,3,5-TRIAZIN; DPX-L5296; L5296
401-360-5
5248-39-5
Acute Tox. 4; STOT RE 2
4-methyl-3-oxo-N-phenyl-2-(phenylmethylene)pentanamide
425-860-8
125971-57-5
Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.1 3,7]decan-2-ol
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.13,7]dec-2-yl acetate
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
4-methyl-m-phenylene diisocyanate; toluene-2,6-di-isocyanate
209-544-5
584-84-9
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
yes
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
4-methyl-N-(methylsulfonyl)benzenesulfonamide
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
4-methylheptane
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
4-methylpent-3-en-2-one; mesityl oxide
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
4-methylpentan-2-ol; methyl isobutyl carbinol
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
4-methylpentan-2-one; isobutyl methyl ketone
203-550-1
108-10-1
Flam. Liq. 2; Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
4-methylpyridine; 4-picoline
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
4-nitrobiphenyl
202-204-7
92-93-3
Carc. 1B
4-nitrophenol; p-nitrophenol
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
4-nitrosoaniline
211-535-6
659-49-4
Acute Tox. 4
4-nitrosophenol
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
4-nitrotoluene
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
4-nonylphenol, branched
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
4-Nonylphenol, branched and linear
-
-
yes
4-Nonylphenol, branched and linear, ethoxylated
-
-
yes
4-Nonylphenol, branched, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
4-Nonylphenol, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
4-nonylphenol, reaction products with formaldehyde and dodecane-1-thiol
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
4-o-tolylazo-o-toluidine; 4-amino-2',3-dimethylazobenzene; fast garnet GBC base; AAT; o-aminoazotoluene
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
4-oxo-4-(p-tolyl)butyric acid adduct with 4-ethylmorpholine
419-240-6
171054-89-0
Eye Dam. 1
4-phenylbut-1-ene
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
4-propylcyclohexanone
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
4-tert-butylbenzoic acid
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
4-tert-butylphenol
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
4-tert-Octylphenol monoethoxylate
621-345-9
2315-67-5
yes
4-vinylcyclohexene
202-848-9
100-40-3
Carc. 2
4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)-one; flupyradifurone
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
4H-3,1-benzoxazine-2,4(1H)-dione
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
5(or 6)-tert-butyl-2'-chloro-6'-ethylamino-3',7'-dimethylspiro(isobenzofuran-1(1H),9'-xanthene)-3-one
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
5,5-dimethyl-3-oxocyclohex-1-enyl dimethylcarbamate 5,5-dimethyldihydroresorcinol dimethylcarbamate; dimetan
204-525-8
122-15-6
Acute Tox. 3
5,5-dimethyl-perhydro-pyrimidin-2-one α-(4-trifluoromethylstyryl)-α-(4-trifluoromethyl)cinnamylidenehydrazone
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
5,6,12,13-tetrachloroanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
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