4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Type of information:

other: Expert assessment

Adequacy of study:

supporting study

Study period:

2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

An expert assessment was performed by a qualified toxicologist using physical-chemical properties and available toxicological data.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide

EC Number:

276-602-4

EC Name:

4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide

Cas Number:

72363-26-9

Molecular formula:

C25H24N2O7S

IUPAC Name:

4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Identification: FAT 40444/B TE
Lot.: PCR92X140707
Appearance: Red powder

Specific details on test material used for the study:

None

Results and discussion

Any other information on results incl. tables

Absorption

The vapour pressure value is very low and the molecular weight relatively high exposure making the risk of inhalation exposure unlikely. A single oral dose toxicity study provided no evidence of systemic toxicity. Furthermore, the relatively high octanol-water partition coefficient would mean there would be limited passage of FAT 40444/B across biological membranes.

Distribution

There is minimal information available relating to the distribution of FAT 40444/B. However, the low water-solubility and general physico-chemical characteristics would imply the most probable route of absorption would take place along the gastrointestinal tract with potential systemic distribution via serum. The lack of evidence to suggest the test item is a skin sensitizer suggests that it would not bind to carrier proteins in the circulatory system. Furthermore while there is also a potential for accumulation in adipose tissue to occur the studies conducted showed no evidence of this and that where it to occur the risk of systemic toxicity would be minimal.

Metabolism

There are no repeated dose studies available to indicate if the test item is subjected to hepatic metabolism. However, the results of the genotoxicity assays have shown that genotoxicity is neither enhanced nor diminished in the presence of the S9 metabolising system.

Excretion

The most plausible route of clearance for low water soluble materials such as FAT 40444/B would be by transfer of test material and/or metabolites from the plasma to the bile through the hepatocytes leading to clearance of any metabolic breakdown products primarily via the faeces.

Applicant's summary and conclusion

Conclusions:

The available information suggests that any absorption of FAT 40444/B will primarily take place in the gastrointestinal tract following oral ingestion. Once absorbed, the substance most likely would be distributed in the serum with excretion primarily being via the faeces.

Executive summary:

No absorption, distribution, metabolism and excretion studies are available for FAT 40444/B. Therefore, the toxicokinetic assessment of this test item has been predicted based on its physico-chemical properties and on the available toxicological study data that has been provided. The information available indicates absorption of the test substance following oral administration would take place via the gastrointestinal tract and once absorbed, the substance may be distributed in the serum. Supporting information would suggest the risk of systemic toxicity from oral, skin and eye contact or from particle inhalation to be minimal. There is no evidence suggesting how the test substance may be metabolised nor studies performed to identify metabolites. However, the results of the genotoxicity assays all proved negative. Excretion of FAT 40444/B and any of its predicted metabolites is expected to be primarily from the faeces.