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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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
(Z)-but-2-ene
209-673-7
590-18-1
Flam. Gas 1; Press. Gas
(Z)-octadec-9-enylamine
204-015-5
112-90-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one
253-242-6
36861-47-9
yes
(±)-1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
(±)-1-[2-(allyloxy)ethyl-2-(2,4- dichlorophenyl)]-1H-imid azolium hydrogen sulphate
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
(±)-1-methyl-4-(1-methylvinyl)cyclohexene;dipentene; limonene
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(±)-1-methyl-4-(1-methylvinyl)cyclohexene;dipentene; limonene
205-341-0
138-86-3;7705-14-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
(±)-butan-2-ol;butan-2-ol
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
(±)-butan-2-ol;butan-2-ol
201-158-5
15892-23-6;78-92-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
1,1',1'-nitrilotripropan-2-ol; triisopropanolamine
204-528-4
122-20-3
Eye Irrit. 2
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
1,1'-dioxybiscyclohexan-1-ol [> 91 % solution];1,1'-dioxybiscyclohexan-1-ol [≤ 91 % solution]
219-306-2
2407-94-5
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
1,1'-iminodipropan-2-ol; di-isopropanolamine
203-820-9
110-97-4
Eye Irrit. 2
1,1,1-trichloroethane; methyl chloroform
200-756-3
71-55-6
Acute Tox. 4
1,1,2,2-tetrabromoethane
201-191-5
79-27-6
Acute Tox. 2; Eye Irrit. 2
1,1,2,2-tetrachloroethane
201-197-8
79-34-5
Acute Tox. 2; Acute Tox. 1
1,1,2-trichloroethane
201-166-9
79-00-5
Carc. 2; Acute Tox. 4
1,1-dichloro-1-nitroethane
209-854-0
594-72-9
Acute Tox. 3
1,1-dichloroethane
200-863-5
75-34-3
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
1,1-dichloroethylene; vinylidene chloride
200-864-0
75-35-4
Flam. Liq. 1; Carc. 2; Acute Tox. 4
1,1-dichloropropene
209-253-3
563-58-6
Flam. Liq. 2; Acute Tox. 3
1,1-diethoxyethane; acetal
203-310-6
105-57-7
Flam. Liq. 2; Eye Irrit. 2; Skin Irrit. 2
1,1-dimethoxyethane; dimethyl acetal
208-589-8
534-15-6
Flam. Liq. 2
1,1-dimethylpiperidinium chloride; mepiquat chloride
246-147-6
24307-26-4
Acute Tox. 4
1,10-phenanthroline
200-629-2
66-71-7
Acute Tox. 3
1,2,3,4,5,6-hexachlorcyclohexanes with the exception of those specified elsewhere in this Annex
210-168-9
608-73-1
Carc. 2; Acute Tox. 3; Acute Tox. 4
1,2,3,4-tetrahydro-1-naphthyl hydroperoxide
212-230-0
771-29-9
Org. Perox. D; Acute Tox. 4; Skin Corr. 1B
1,2,3,4-tetrahydronaphthalene
204-340-2
119-64-2
Eye Irrit. 2; Skin Irrit. 2
1,2,3,6-tetrahydro-3,6-methanophthalic anhydride
212-557-9
826-62-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydro-3-methylphthalic anhydride
226-247-6
5333-84-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydro-4-methylphthalic anhydride
222-323-8
3425-89-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydromethylphthalic anhydride
247-830-1
26590-20-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydrophthalic anhydride
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3-trichloropropane
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
1,2,4-triazole
206-022-9
288-88-0
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
1,2,4-trichlorobenzene
204-428-0
120-82-1
Acute Tox. 4; Skin Irrit. 2
1,2,4-trimethylbenzene
202-436-9
95-63-6
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,2,5,6,9,10-hexabromocyclododecane
221-695-9
3194-55-6
Repr. 2; Lact.
yes
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters
271-094-0
68515-51-5
yes
1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear
271-093-5
68515-50-4
Repr. 1B
yes
1,2-benzenedicarboxylic acid, dipentylester, branched and linear
284-032-2
84777-06-0
Repr. 1B
yes
1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters
272-013-1
68648-93-1
yes
1,2-benzenedicarboxylic acid; di-C6-8-branched alkylesters, C7-rich
276-158-1
71888-89-6
Repr. 1B
yes
1,2-benzenedicarboxylic acid; di-C7-11-branched and linear alkylesters
271-084-6
68515-42-4
Repr. 1B
yes
1,2-benzisothiazol-3(2H)-one;1,2-benzisothiazolin-3-one
220-120-9
2634-33-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
1,2-bis(2-methoxyethoxy)ethane; TEGDME; triethylene glycol dimethyl ether; triglyme
203-977-3
112-49-2
Repr. 1B
yes
1,2-dibromo-3-chloropropane
202-479-3
96-12-8
Carc. 1B; Muta. 1B; Repr. 1A; Acute Tox. 3; STOT RE 2
1,2-dibromoethane
203-444-5
106-93-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,2-dichlorobenzene; o-dichlorobenzene
202-425-9
95-50-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1,2-dichloroethane; ethylene dichloride
203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
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