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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)

Data source

Reference
Reference Type:
publication
Title:
The Metabolism and Excretion of Black PN in the Rat and Man
Author:
A. J. RYAN and P. G. WELLING
Year:
1970
Bibliographic source:
Food Cosmet. Toxicol. Vol. 8, pp. 487—497, 1970

Materials and methods

Objective of study:
metabolism
Test guideline
Qualifier:
according to
Guideline:
other: as below
Principles of method if other than guideline:
In Vivo Metabolism and Excretion of Black PN in the Rat
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Brilliant Black PN - Molecular formula (if other than submission substance):C28-H21-N5-O14-S4.4Na- Molecular weight (if other than submission substance):867.6873 g/mole- Substance type:Organic- Physical state:No data available- Impurities (identity and concentrations):8.2 %
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
Oral doses of Black PN (20-100 mg/rat) were given in aqueous solution by stomach tube
Duration and frequency of treatment / exposure:
1 day
Doses / concentrations
Remarks:
Doses / Concentrations:20-100 mg
No. of animals per sex per dose:
Data not available
Control animals:
not specified
Positive control:
Data not available
Details on study design:
Data not available
Details on dosing and sampling:
Data not available
Statistics:
Data not available

Results and discussion

Preliminary studies:
Data not available
Main ADME resultsopen allclose all
Type:
absorption
Results:
Data not available
Type:
distribution
Results:
Data not available
Type:
metabolism
Results:
Sulphanilic acid (SA) and 4-acetamido-l-naphthylamine-6 or 7-sulphonic acid (ANSA) were detected in urine and traces of Black PN, ANSA and large amounts of SA, DSA and AHNDA in faeces
Type:
excretion
Results:
Not excreted in urine

Toxicokinetic / pharmacokinetic studies

Details on absorption:
No data available
Details on distribution in tissues:
No data available
Details on excretion:
No unchanged Black PN and any coloured metabolites were found in the urine and 48-hr faeces were very dark in colour.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Only Sulphanilic acid (SA) and 4-acetamido-l-naphthylamine-6 or 7-sulphonic acid (ANSA) were detected in urine and traces of Black PN, ANSA and large amounts of SA, DSA and AHNDA in faeces were observed.

Any other information on results incl. tables

Excretion of Black PN and metabolites in rats dosed with the colouring

Species

Route of dosage

Excretory route 

Black PN

SNSA

SA

DSA

ANSA

AHNDA

Rat

Oral

Urine

--

--

+

--

+

--

 

 

Faeces

+ *

--

+

+

+

+

+ = Compound present -- = Compound absent

*Found only after single dose of 100 mg/rat.

 

Quantitative excretion of metabolites of Black PN after a single oral dose of the colouring to rats

Metabolite

excreted

Excretory source

Time (hr)

Excretion of metabolite ( % of theoretical yield) with Black PN dose of

 

 

 

20 mg/rat

100 mg/rat*

SA

Urine

24

36.7

40.5

 

 

48

6.9

15.8

 

 

72

0.9

2.5

 

Total

 

 

 

 

Faeces

48

29.5

30.2

 

Total

 

35.2

33.0

 

Urine/faece

 

 

 

 

Total

 

79.7

91.8

ANSA

Urine

24

 

< 1.0

 

 

 

 

 

 

Faeces

48

 

< 1.0

 *Trace of Black PN in faeces.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study resultsBrilliant Black PN expected to have Low bio-accumulation potential based on study results.
Executive summary:

In a in vivo metabolism and elimination study, Wistar male rats were treated with Black PN in the concentration of 20-100 mg/rat orally in aqueous solution by stomach tube.No unchanged Black PN and any coloured metabolites were found in the urine.Only Sulphanilic acid (SA) and 4-acetamido-l-naphthylamine-6 or 7-sulphonic acid (ANSA) were detected in urine. Similarly, 48-hr faeces were very dark in colour and traces of Black PN, ANSA and large amounts of SA, DSA and AHNDA in faeces were observed. Therefore, Black PN did not alter excretion or metabolite patternsand it is considered to haveLow bio-accumulation potential based on study results.