Registration Dossier
Registration Dossier
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EC number: 239-763-1 | CAS number: 15680-42-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2016
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- The copper content in liver after 14 days of gavage dosing at 1000 and 300 mg/kg bw was quantified.
- GLP compliance:
- no
Test material
- Reference substance name:
- [1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper
- EC Number:
- 239-763-1
- EC Name:
- [1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper
- Cas Number:
- 15680-42-9
- Molecular formula:
- C17H11CuNO2
- IUPAC Name:
- [1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper
- Test material form:
- solid: nanoform
- Details on test material:
- - Substance type: pigment
- Physical state: Solid / greenish yellow
- Name of test material (as cited in study report): Irgazin Yellow L 0800
- Lot/batch No.: 0005629903
- Analytical purity: 99.0 %
- Purity test date: 2013
- Expiration date of the lot/batch: unlimited stability under storage conditions
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Date of manufacture: 01 Dec 2011
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- age at starting of administration: about 11-12 weeks
single caging
food and water ad libitum
Temperature 20-24°C;
humidity 30-70%;
15 air changes per hour
12 hours light from 06:00 h to 18:00 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration and frequency of treatment / exposure:
- 14 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
300, 1000 mg/kg bw
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- yes, concurrent vehicle
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- After 14 days of gavage dosing, the copper content in liver is dose-dependently increased.
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
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