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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
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 EFSA journal and IARC monograph.

Data source

Reference
Reference Type:
publication
Title:
Opinion of the Scientific Panel on Food Additives,Flavourings,Processing Aids and Materials in Contact with Food on a request from the Commission to Review the toxicology of number of dyes illegally present in food in the EU Question number EFSA-2005-082
Author:
European Food Safety Authority
Year:
2005
Bibliographic source:
The EFSA Journal (2005) 263, 1-71

Materials and methods

Objective of study:
excretion
metabolism
Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Metabolism and excretion of the target substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol was studied in rats.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material : C.I. Solvent Orange 7
- Molecular formula : C18H16NO
- Molecular weight : 276.3374 g/mol
- Smiles notation : Cc1ccc(N=Nc2c(O)ccc3ccccc23)c(C)c1
- InChl : 1S/C18H16N2O/c1-12-7-9-16(13(2)11-12)19-20-18-15-6-4-3-5-14(15)8-10-17(18)21/h3-11,21H,1-2H3/b20-19+
- Substance type:Organic
- Physical appearance : Solid
Radiolabelling:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
no data
Duration and frequency of treatment / exposure:
no data
Doses / concentrations
Remarks:
not specified
No. of animals per sex per dose:
no data
Control animals:
not specified
Positive control:
no data
Details on study design:
no data
Details on dosing and sampling:
no data
Statistics:
no data

Results and discussion

Main ADME resultsopen allclose all
Type:
metabolism
Results:
Th dye was easily reduced by intestinal bacteria to 1-amino-2naphthyl sulphate and eight 8 other metabolites, five of whch were red-coloured
Type:
excretion
Results:
excreted in urine

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
1-amino-2naphthyl sulphate and 8 other metabolites (name not specified)

Applicant's summary and conclusion

Conclusions:
The dye 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol is said to be easily reduced by intestinal bacteria, after gavage administration to rats in corn oil 1-amino-2naphthyl sulphate and 8 other metabolites were excreted in urine.
Executive summary:

The dye 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol is said to be easily reduced by intestinal bacteria, after gavage administration to rats in corn oil 1-amino-2naphthyl sulphate and 8 other metabolites were excreted in urine.