Registration Dossier
Registration Dossier
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EC number: 229-313-2 | CAS number: 6471-49-4
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from NTP
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicology and Carcinogenesis Studies of C.I. Pigment Red 23 (CAS No. 6471-49-4) in F344 Rats and B6C3F1 Mice (Feed Studies)
- Author:
- U.S. DEPARTMENT OFCOMMERCE National Technical Information Service
- Year:
- 1 992
- Bibliographic source:
- NATIONAL TOXICOLOGY PROGRAM. Technical Report Series. No.411, PB93-228435
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Metabolism and disposition of C.1. Pigment Red 23 in rats
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- EC Number:
- 229-313-2
- EC Name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Cas Number:
- 6471-49-4
- Molecular formula:
- C24H17N5O7
- IUPAC Name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Details on test material:
- Name: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
SMILES:COc1ccc(N(=O)=O)cc1N=Nc1c2ccccc2cc(C(=O)Nc2cccc(N(=O)=O)c2)c1O
InChI:1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
Molecular Formula: C24H17N5O7
Molecular Weight: 487.4263 g/mole
Constituent 1
- Specific details on test material used for the study:
- Name: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
SMILES:COc1ccc(N(=O)=O)cc1N=Nc1c2ccccc2cc(C(=O)Nc2cccc(N(=O)=O)c2)c1O
InChI:1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
Molecular Formula: C24H17N5O7
Molecular Weight: 487.4263 g/mole - Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 7 to 8 weeks old)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on exposure:
- not specified
- Duration and frequency of treatment / exposure:
- single dose
Doses / concentrations
- Dose / conc.:
- 5.3 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- not specified
- Control animals:
- not specified
- Positive control reference chemical:
- not specified
- Details on study design:
- not specified
- Details on dosing and sampling:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary studies:
- not specified
Main ADME results
- Type:
- excretion
- Results:
- Nearly all of the pigment (93% ± 16%) was recovered in the feces 48 hours after administration. No pigment was found in plasma, whole blood, liver, kidney, or lungs of treated animals at any time period even after administering 10 times this dose
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- not specified
- Details on distribution in tissues:
- not specified
- Details on excretion:
- Nearly all of the pigment (93% ± 16%) was recovered in the feces 48 hours after administration. No pigment was found in plasma, whole blood, liver, kidney, or lungs of treated animals at any time period even after administering 10 times this dose
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- not specified
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- not specified
Applicant's summary and conclusion
- Conclusions:
- C.1. Pigment Red 23 was considered to be have Low bio-accumulation potential in rats based on study results.
- Executive summary:
Upon oral administration, C.1. Pigment Red 23 were Nearly all of the pigment (93% ± 16%) was recovered in the feces 48 hours after administration. No pigment was found in plasma, whole blood, liver, kidney, or lungs of treated animals at any time period even after administering 10 times this dose. Therefore, C.1. Pigment Red 23 was considered to be have Low bio-accumulation potential in rats based on study results.
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