Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt

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:

other: Experimental data from authoritative journal

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1955

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

The objective of the study was to determine precisely the fate after ingestion of all the FD&C triphenylmethane colors, FD&C Blue No. 1, FD&C Green No. 1, FD&C Green No.2, FD&C Green No.3, and FD&C Violet No. 1 colors.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt

EC Number:

219-091-5

EC Name:

Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt

Cas Number:

2353-45-9

Molecular formula:

C37H36N2O10S3.2Na

IUPAC Name:

disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)-5-hydroxybenzenesulfonate

Constituent 2

Reference substance name:

dihydrogen(ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino] (4-hydroxy-2-sulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene] (3-sulphonatobenzyl)ammonium,disodium salt [Synonym FD&C Green No.3 & Fast Green FCF]

IUPAC Name:

dihydrogen(ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino] (4-hydroxy-2-sulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene] (3-sulphonatobenzyl)ammonium,disodium salt [Synonym FD&C Green No.3 & Fast Green FCF]

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

CAS No: 2353-45-9Chemical Name: Benzenemethanaminium,N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-,inner salt, sodium salt [Synonym FD&C Green No.3 & Fast Green FCF]Nature of chemical: Organic

Radiolabelling:

no

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

Three male and three female adult Osborne-Mendel rats, weighing between 450-500 gm. and 200-250 gm. respectively, were starved for 24 hours, and then each given 200 mg of color dissolved in 10 ml. of water per os.The rats were then placed in metabolism where food and water were available, and the urine and feces were collected for 36 hours when the feces no longer showed any trace of the administered color.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on exposure:

Three male and three female adult Osborne-Mendel rats, weighing between 450-500 gm. and 200-250 gm. respectively, were starved for 24 hours, and then each given 200 mg of color dissolved in 10 ml. of water per os.The rats were then placed in metabolism where food and water were available, and the urine and feces were collected for 36 hours when the feces no longer showed any trace of the administered color.

Duration and frequency of treatment / exposure:

Exposure period: 36 hours

Doses / concentrations

Remarks:

Doses / Concentrations:200 mg

No. of animals per sex per dose / concentration:

3 male & 3 female rats

Control animals:

not specified

Results and discussion

Main ADME results

Main ADME results 1

Type:

absorption

Results:

Upon administraton by mouth (oral), the color was absorbed in the gastro-intestinal tract. There was some evidence that more color was absorbed in the upper portion of the intestinal tract than in the lower portion.

Main ADME results 2

Type:

distribution

Results:

The administered color was distibuted through the gut, and kidneys

Main ADME results 3

Type:

metabolism

Results:

The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates very poor metabolism of the administered color.

Main ADME results 4

Type:

excretion

Results:

The average percentage of the FD&C Green No.3 colour recovered in rats was 94% (standard error of average 1.32) in 36 hours. None of the colors was found in the urine

Metabolite characterisation studies

Metabolites identified:

no

Any other information on results incl. tables

It was found that the administered colors with one exception were almost completely excreted in the feces of the test animals (male & female). The average percentage of theFD&C Green No.3 colour recovered in rats was 94% (standard error of average 1.32) in 36 hours. None of the colors was found in the urine, and since they were nearly all excreted in the feces, bio-accumulation potential of the color after a single administration appears to be low in rats

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study resultsIn an in-vivo study conducted on 3 male and female adult Osborne-Mendel rats, who were administered 200 mg of the color FD&C Green No.3 as a single dose, almost complete recovery (94%) of the administered color was found in the excreta of the rats in 36 hours. None of the colors was found in the urine. The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates poor metabolism of the administered color. Thus, it can be concluded that the color FD&C Green No.3 when administered as a single dose by the oral route to the rats is likely to exhibit low bio-accumulation potential.

Executive summary:

In an in-vivo study conducted on 3 male and female adult Osborne-Mendel rats, who were administered 200 mg of the color FD&C Green No.3 as a single dose, almost complete recovery (94%) of the administered color was found in the excreta of the rats in 36 hours.None of the colors was found in the urine.The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates poor metabolism of the administered color.

 

Thus, it can be concluded that thecolorFD&C Green No.3 when administered as a single dose by the oral route to the rats is likely to exhibit low bio-accumulation potential.