REAKTIVE GELB F 97494

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Type of information:

other: Based on available physico-chemical properties and toxicological data of the substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Assessment based on physico-chemical properties and toxicological data of the substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Objective of study:

other: Toxicokinetic assessment

Principles of method if other than guideline:

An expert assessment was made based on physical chemical properties and all toxicity data available.

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-090-0

EC Name:

-

Cas Number:

477795-15-6

Molecular formula:

C26H24FN8Na3O14S4

IUPAC Name:

Trisodium 2-{2-[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3-yl]diazen-1-yl}-4-{[4-fluoro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}benzene-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktivgelb F-97494

Administration / exposure

Details on study design:

A toxicokinetic assessment has been performed based on available physico-chemical properties and toxicological data (i.e., acute oral toxicity, acute dermal toxicity skin irritation eye irritation skin sensitization subacute (28 d) oral toxicity, bacterial reverse mutation test, in vitro chromosome aberration test and in vivo micronucleus test) of the test substance.

Results and discussion

Any other information on results incl. tables

Evaluation and assessment:

The data of the acute dermal toxicity, dermal irritation and skin sensitization test indicate little or no dermal absorption, owing to the fact that no irritating or sensitizing effects were observed. This is in accordance with the physico-chemical properties of test substance. Oral absorption of test substance is probably also restricted due to the low log Ko/w of <-4.9 since most substances with a log Ko/w <0.5 are only marginally absorbed. However, after oral gavage test substance is at least partially absorbed. This can be concluded from the data obtained in the acute oral toxicity study with females, in which yellowish discolorations of the urine between 1-2 and 4-8 h after administration were observed. As test substance is an azo dye, partial metabolic cleavage by bacterial azo reductases in the intestine resulting in more hydrophilic amines seems to be likely. Due to the physico-chemical properties of test substance an accumulation of the test substance in the fatty tissues of the body is unlikely. Likewise, distribution or accumulation in other organs was not observed after oral administration. The elimination of the absorbed test substance fraction seems to be very efficient, as urine discoloration disappeared 24 h after administration. It can be assumed that the test substance is also eliminated via faeces, as substances with a molecular weight above 300 g/mol are preferentially excreted via the faeces in rats.

In summary, based on the high water solubility, low log Ko/w, and the results obtained in various toxicological examinations it can be concluded that test substance does not show any toxicokinetic peculiarity.

Applicant's summary and conclusion

Conclusions:

The test substance is not expected to be absorbed to a high extent via the oral or dermal exposure routes. Based on its physico-chemical properties, accumulation of the test substance in the fatty tissues of the body is unlikely. Elimination of the absorbed test substance fraction seems to be very efficient.

Executive summary:

A toxicokinetic assessment was conducted based on available physico-chemical properties and toxicological data of the test substance.

 

Based on physico-chemical properties of test substance, oral absorption is probably restricted due to the low log Kow of <-4.9. Most substances with a log Kow <0.5 are only marginally absorbed. Likewise, the data of the acute dermal toxicity, dermal irritation and skin sensitization tests indicates little or no dermal absorption, owing to the fact that no irritating or sensitizing effects were observed. However, an acute oral toxicity study with females in which yellowish discolorations of the urine between 1-2 and 4-8 h after administration were observed suggests that the test substance is at least partially absorbed after oral (gavage) exposure. As the test substance is an azo dye, it may undergo partial metabolic cleavage by bacterial azo-reductases in the intestine, resulting in more hydrophilic amines.

 

Based on its physico-chemical properties, accumulation of the test substance in the fatty tissues of the body is unlikely. Distribution or accumulation in other organs was not observed after oral administration. The elimination of the absorbed test substance fraction seems to be very efficient, as urine discoloration disappeared 24 h after administration. It can be assumed that the test substance is also eliminated via feces, as substances with a molecular weight above 300 g/mol are preferentially excreted via the feces in rats.

 

In light of available information, it can be concluded that test substance does not show any toxicokinetic peculiarity.