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-)

Endpoint summary

Link to relevant study record(s)

Reference

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

Objective of study:

other: Assessment of toxicokinetic behaviour

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

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

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.

Metabolites identified:

no

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.

Description of key information

FAT40825/A is expected to have a low bioaccumulation potential in the human body and also is poorly absorbed by oral and dermal route (10 % absorption expected conservatively). Due to its fine particle size the substance is capable of reaching the alveolar region in the lungs and thus inhalative absorption might be higher (80 % absorption rate proposed). However, it should be noted that FAT40825 is only placed onto the market in a dedusted form respectively in a granulated form and thus in practical handling and use inhalation of dust particles is technically minimized.

Key value for chemical safety assessment

Bioaccumulation potential:

low bioaccumulation potential

Absorption rate - oral (%):

10

Absorption rate - dermal (%):

10

Absorption rate - inhalation (%):

80

Additional information

Due to the physico-chemical properties (i.e., high molecular weight, high water solubility, particle size is less than 10 µm, low LogPow) FAT40825/A is expected to be absorbed in human body via different routes - oral (assumed 10 %), dermal (assumed 10 %) and inhalation (assumed 80 %). Following absorption, FAT40825/A is anticipated to be distributed in blood, lung, liver and kidney. Excretion is expected via urine, bile or feces, and as a conclusion FAT 40825/A has a poor accumulation potential in the human body.