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

Type of information:

other: Available Data on Toxicokinetics

Adequacy of study:

supporting study

Study period:

2007

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

other: Assessment

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Objective of study:

other: Assessment of toxicokinetic behaviour

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

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

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

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.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: negligible bioaccumulation potential
FAT40825/A has a negligible potentail for absorption by the dermal route and low resp. moderate potential for oral/inhaltive absorption. Accumulation in tissue is not expected and thus a negligible bioaccumualtion 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.