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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vivo
Adequacy of study:
weight of evidence

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Metabolism and Disposition of Calcimimetic Agent Cinacalcet HCl in Humans and Anmial Models
Author:
Kumar et al.
Year:
2004
Bibliographic source:
Drug Metabolism and Disposition, 32(12): 1491-1500
Reference Type:
publication
Title:
No information
Author:
Curtis D. Klaassen
Year:
2001
Bibliographic source:
Casarett and Doull's Toxicology: The Basic Science of Poisons, 6th Ed.
Reference Type:
publication
Title:
Naphthalene--an environmental and occupational toxicant.
Author:
Preuss. R. et al.
Year:
2003
Bibliographic source:
Int Arch Occup Environ Health, 76(8):556-76
Reference Type:
publication
Title:
IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Volume 82 - Some Traditional Herbal Medicines, Some Mycotoxins, Naphthalene and Styrene
Author:
IARC
Year:
2002
Bibliographic source:
http://monographs.iarc.fr/ENG/Monographs/vol82/mono82.pdf
Reference Type:
publication
Title:
Human UDP-Glucuronyltransferases: Metabolism, Expression and Disease
Author:
Tukey and Strassburg
Year:
2000
Bibliographic source:
Annu. Rev. Pharmacol. Toxicol. 2000. 40:581–616
Reference Type:
secondary source
Title:
HSBDB Entry for 3-hydroxy-2-naphthoic acid
Author:
National Library of Medicine
Bibliographic source:
Hazardous Substances Data Bank [Internet]. Bethesda (MD): National Library of Medicine (US), Division of Specialized Information Services. 1986 - [cited 2013 May 14]. Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB

Materials and methods

GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Cincacalcet
IUPAC Name:
Cincacalcet
Constituent 2
Reference substance name:
Mimpara
IUPAC Name:
Mimpara
Constituent 3
Reference substance name:
226256-56-0
Cas Number:
226256-56-0
IUPAC Name:
226256-56-0
Constituent 4
Reference substance name:
3-hydroxy-2-naphthoic acid
EC Number:
202-180-8
EC Name:
3-hydroxy-2-naphthoic acid
Cas Number:
92-70-6
IUPAC Name:
3-hydroxy-2-naphthoic acid
Constituent 5
Reference substance name:
1-naphthoic acid
EC Number:
201-681-9
EC Name:
1-naphthoic acid
Cas Number:
86-55-5
IUPAC Name:
1-naphthoic acid
Constituent 6
Reference substance name:
2-naphthoic acid
EC Number:
202-217-8
EC Name:
2-naphthoic acid
Cas Number:
93-09-4
IUPAC Name:
2-naphthoic acid
Test material form:
other:
Details on test material:
- Name of test material (as cited in study report): [14C-2-CH2]Cinacalcet and [14C-CF3]Cinacalcet
- Physical state: Solid, aministered via capsule
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:
Radiolabelling:
yes
Remarks:
14C studies for Cinacalcet

Results and discussion

Applicant's summary and conclusion