Reaction mass of Potassium sodium 3-{[4-({3-(substitutedamino)-4-[(2-sulfonato-4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]phenyl}amino)-6-chloro-heteromonocyl-2-yl]amino}-2-substituted-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate (1:3:1) and Potassium sodium 3-[(4-{[3-(subsitutedamino)-4-{[4-(ethenylsulfonyl)-2-sulfonatophenyl]diazenyl}phenyl]amino}-6-chloro-heteromonocy-2-yl)amino]-2-substituted-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate (3:9:3)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: Expert assessment

Adequacy of study:

key study

Study period:

The study was conducted on 11 June 2015

Data source

Reference

Reference Type:

other: Expert assessment

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Principles of method if other than guideline:

A paper-based toxicokinetic assessment has been conducted for this substance.

Test material

Test material information

Constituent 1

Results and discussion

Any other information on results incl. tables

A paper-based toxicokinetic assessment has been conducted for this substance. Available studies were reviewed by a qualified toxicologist. The assessment of the likely toxicokinetic behaviour of the test item was provided to the extent that can be derived from the relevant available information at the time of the assessment. The available information suggests that the test item is not readily bioavailable via the oral, dermal or inhalation routes. This is supported by the physico-chemical and toxicological properties of the test item. If any absorption occurs, the test item would most likely be distributed systemically in the serum. Urinary excretion is considered to be the significant route for the test item.

Applicant's summary and conclusion

Executive summary:

A paper-based toxicokinetic assessment has been conducted for this substance. Available studies were reviewed by a qualified toxicologist. The assessment of the likely toxicokinetic behaviour of the test item was provided to the extent that can be derived from the relevant available information at the time of the assessment. The available information suggests that the test item is not readily bioavailable via the oral, dermal or inhalation routes. This is supported by the physico-chemical and toxicological properties of the test item. If any absorption occurs, the test item would most likely be distributed systemically in the serum. Urinary excretion is considered to be the significant route for the test item.