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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 lipnja 2024. Database contains 4821 unique substances/entries.
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217-862-0
1987-50-4
yes
-
-
yes
430-840-7
202483-63-4
Skin Sens. 1
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
204-626-7
123-42-2
Eye Irrit. 2
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
608-055-8
27147-75-7;27459-10-5
yes
608-055-8
27147-75-7;27459-10-5
yes
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
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
425-860-8
125971-57-5
Skin Sens. 1
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
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
202-453-1
95-80-7
yes
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
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
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
203-550-1
108-10-1
Flam. Liq. 2; Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-204-7
92-93-3
Carc. 1B
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
211-535-6
659-49-4
Acute Tox. 4
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
202-808-0
99-99-0
Acute Tox. 3; STOT RE 2
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
-
-
yes
-
-
yes
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
419-240-6
171054-89-0
Eye Dam. 1
4-PHENYL-1-BUTENE; SQ 31,175; SQ31175
405-980-7
768-56-9
Skin Irrit. 2
BICH-3 STUFE 3
406-810-4
40649-36-3
Skin Irrit. 2
202-696-3
98-73-7
Repr. 1B; STOT RE 1; Acute Tox. 4
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
621-345-9
2315-67-5
yes
202-848-9
100-40-3
Carc. 2
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
204-525-8
122-15-6
Acute Tox. 3
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
251-684-4
33813-20-6
Acute Tox. 4
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
IMEXINE OAY
412-130-9
3131-52-0
Acute Tox. 4; Eye Dam. 1
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
410-530-8
107815-88-3
Skin Sens. 1
WAY-128170
420-820-6
153042-18-3
Flam. Liq. 3; Acute Tox. 4
-
51-14-9
Acute Tox. 4
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
CDFP
410-090-7
89402-43-7
Flam. Liq. 3; Acute Tox. 4
429-290-0
3380-30-1
Eye Dam. 1
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
414-470-3
95885-13-5
Acute Tox. 4
619-823-7
494793-67-8
Carc. 2
208-793-7
541-85-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
210-025-0
602-87-9
Carc. 1B
-
-
yes
-
-
yes
-
-
yes
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
441-550-5
-
Self-react. C; Carc. 2
204-327-1
119-47-1
Repr. 1B
yes
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
239-732-2
15662-33-6
Acute Tox. 4
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; 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
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1

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