tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: Based on available physico-chemical properties and toxicological data of the substance

Adequacy of study:

key study

Study period:

Jan. 28, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP assessment based on physico-chemical properties and toxicological data of the substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Objective of study:

other: Toxicokinetic assessment

Principles of method if other than guideline:

An expert assessment was made based on physical chemical properties and all toxicity data available.

GLP compliance:

no

Remarks:

Not applicable

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-550-6

EC Name:

-

Cas Number:

243858-01-7

Molecular formula:

Hill formula: C25H22FN7Na4O16S5 CAS formula: C25H26FN7O16S5.4Na

IUPAC Name:

tetrasodium 2-({4-fluoro-6-[methyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-5-hydroxy-6-[2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate

Test material form:

solid: particulate/powder

Administration / exposure

Details on study design:

A toxicokinetic assessment has been performed based on available physico-chemical properties and toxicological data (i.e., acute oral toxicity, acute dermal toxicity, skin irritation, eye irritation, skin sensitisation, subacute (28 d) oral toxicity, bacterial reverse mutation test and in vitro chromosome aberration test) of the test substance.

Results and discussion

Metabolite characterisation studies

Metabolites identified:

not specified

Any other information on results incl. tables

Evaluation and assessment:

Due to the low partition coefficient and the acidic character of test substance, dermal absorption is unlikely. This is in accordance with the data obtained in the acute dermal toxicity, dermal irritation and skin sensitization study. Oral reabsorption of test substance is also restricted due to the low partition coefficient of -6.2 since most substances with a partition coefficient < 0.5 are only marginally reabsorbed. However, a partial reabsorption after oral gavage can be assumed, since the substance caused discoloration of the serum and some organs. As test substance is an azo dye with an azo bond, a partial metabolic cleavage by bacterial azo-reductases in the intestine resulting in two hydrophilic amines seems to be presumably.

Due to the physico-chemical properties of test substance, accumulation of the chemical in the body is unlikely. This assumption is supported by the decolorisation of the serum, organs and tissues after terminating the application in repeated dose toxicity study, as the blood serum, organs and tissues of the animals of the recovery group were not stained or only in a few animals (testes).

Excretion of the test substance via urine and feces is likely, owing to the fact that molecules up to 15,000 g/mol are easily excreted via the kidneys, as proved by the pigment deposits in the kidneys in repeated dose toxicity study, and substances with a molecular weight above 300 g/mol are preferentially excreted via the feces in rats.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
The test substance is expected to have partial oral reabsorption, with no dermal absorption and no accumulation in the body. Excretion via urine and faeces can be expected.

Executive summary:

A toxicokinetic assessment was conducted based on available physico-chemical properties and toxicological data of the test substance.

Oral reabsorption of test substance is also restricted due to the low partition coefficient of -6.2 since most substances with a partition coefficient < 0.5 are only marginally reabsorbed. However, a partial reabsorption after oral gavage can be assumed, since the substance caused discoloration of the serum and some organs. As test substance is an azo dye with an azo bond, a partial metabolic cleavage by bacterial azo-reductases in the intestine resulting in two hydrophilic amines seems to be presumably. Due to the low partition coefficient and the acidic character of test substance, dermal absorption is also unlikely.

Due to the physico-chemical properties of test substance, accumulation of the chemical in the body is unlikely. This assumption is supported by the decolorisation of the serum, organs and tissues after terminating the application in repeated dose toxicity study, as the blood serum, organs and tissues of the animals of the recovery group were not stained or only in a few animals (testes).

Excretion of the test substance via urine and feces is likely, owing to the fact that molecules up to 15,000 g/mol are easily excreted via the kidneys, as proved by the pigment deposits in the kidneys in repeated dose toxicity study, and substances with a molecular weight above 300 g/mol are preferentially excreted via the feces in rats.

In light of available information, it can be concluded that test substance does not show any toxicokinetic peculiarity.