Tetrasodium [2-({4-fluoro-6-[(2-{[4-fluoro-6-({5-(hydroxykappaO)-6-[(2-{[2-(hydroxy-kappaO)-5-sulfophenyl] diazenyl-kappaN1}-4,5-dimethoxyphenyl) diazenyl-kappaN2]-7-sulfo-2-naphthyl} amino)-1,3,5-triazin-2-yl] amino} propyl) amino]-1,3,5-triazin-2-yl} amino) benzene-1,4- disulfonato(6-)] cuprate(4-)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Type of information:

other: Expert statement

Adequacy of study:

supporting study

Study period:

Study completion date - 16 April 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Objective of study:

other: Assessment of toxicokinetic behaviour

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

An assessment was performed based on available physico-chemical and toxicological data taking general principles of toxicokinetics into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

FAT40825/A

IUPAC Name:

FAT40825/A

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

Identity: FAT 40825/A
Batch number: CHU 297 / BOP 04/05
Purity: Organic part (Na-salt): approx. 83.7 %; All coloured components: approx. 80.54 %; Main component: approx. 59.1 %.
Appearance: Solid, black powder
Storage conditions: At room temperature at about 20 °C
Expiration date: December 31, 2010

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

The water solubility (341 g/l) and the partition coefficient (log Pow <-4.7) of Olive CHU 297 (FAT 40825/A) indicate a negligible potential for passive absorption by diffusion through cell membranes including dermal absorption, and a negligible bioaccumulation potential. The MMD was determined to be 4.6 μm, indicating that the substance has the potential to be inhaled.

Details on distribution in tissues:

The substance and its possible metabolites are anticipated to be distributed from the portal vein blood into the liver and into the kidneys where the soluble metabolites, including conjugated metabolites, are excreted via urine. Since the substance is hydrophilic, has a very low log Pow, and is ionisable, accumulation in fatty tissue is not expected.

Metabolite characterisation studies

Metabolites identified:

no

Applicant's summary and conclusion

Conclusions:

FAT40825/A has a negligible potential for absorption by the dermal route and low resp. moderate potential for oral/inhalative absorption. Accumulation in tissue is not expected and thus a negligible bioaccumulation potential is expected.

Executive summary:

The water solubility (341 g/l) and the partition coefficient (log Pow <-4.7) of Olive CHU 297 (FAT 40825/A) indicate a negligible potential for passive absorption by diffusion through cell membranes including dermal absorption, and a negligible bioaccumulation potential. The MMD was determined to be 4.6 μm, indicating that the substance has the potential to be inhaled.

 

The substance and its possible metabolites are anticipated to be distributed from the portal vein blood into the liver and into the kidneys where the soluble metabolites, including conjugated metabolites, are excreted via urine. Since the substance is hydrophilic, has a very low log Pow, and is ionisable, accumulation in fatty tissue is not expected.