Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

Basic toxicokinetics

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

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

Test material information

Constituent 1

Reference substance name:

Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

EC Number:

219-746-5

EC Name:

Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

Cas Number:

2519-30-4

Molecular formula:

C28H21N5O14S4.4Na

IUPAC Name:

tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate

Constituent 2

Reference substance name:

Brilliant Black PN

IUPAC Name:

Brilliant Black PN

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 / concentration:

Data not available

Control animals:

not specified

Positive control reference chemical:

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 results

Main ADME results 1

Type:

absorption

Results:

Data not available

Main ADME results 2

Type:

distribution

Results:

Data not available

Main ADME results 3

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

Main ADME results 4

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.