2-Naphthalenesulfonic acid, 4-hydroxy-3-[2-[2-methoxy-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-7-[(sulfomethyl)amino]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

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: Non-GLP assessment based on physico-chemical properties and toxicological data of the substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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 such as solubility in various solvents and log POIW and toxicity data available.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

464-700-1

EC Name:

-

Cas Number:

607724-42-5

Molecular formula:

Hill formula: C28H24N5Na5O23S7 CAS formula: C28H29N5O23S7.5Na

IUPAC Name:

pentasodium 4-hydroxy-3-(2-{2-methoxy-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-7-[(sulfonatomethyl)amino]naphthalene-2-sulfonate

Details on test material:

- Name of test material (as cited in study report): Reaktiv Rot F01-0481

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, mammalian chromosome aberration test and in vivo micronucleus test) of the test substance.

Results and discussion

Any other information on results incl. tables

The data of the acute dermal toxicity and dermal irritation test indicate low dermal permeability, owing to the fact that neither systemic toxicity nor relevant irritating effects were observed. This is in accordance with the physico-chemical properties of the test substance. Oral resorption of the test substance is probably also restricted due to the low log P_O/W of < - 2 since most substances with a log P_O/W <0.5 are only marginally resorbed. However, after oral gavage, the test substance is at least partially absorbed. This can be concluded from substance related organ discolorations (skin and kidneys) observed in the subacute toxicity study using high doses. As the test substance is consisted of molecules with azo structures, partial metabolic cleavage by bacterial azo-reductases in the intestine resulting in more hydrophilic amines seems to be likely. After resorption following oral administration, reversible distribution in skin and kidneys is possible as demonstrated by test substance related discolorations, which were reduced after a 14 d recovery period. In the histopathological examination no correlation (like e. g. precipitate) for these discoloration was detected confirming its reversibility.

Reddish discolored feces after oral administration of the test substance indicated that the compound is predominantly eliminated via intestine. This corresponds to the fact that substances with a molecular weight above 300 g/mol are preferentially excreted via the feces in rats. Red or dark yellow discolored urine however showed that test substance elimination also occurs via kidneys/urine.

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

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
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 administered test substance will be predominantly via feces.

Executive summary:

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

The data of the acute dermal toxicity and dermal irritation test indicate low dermal permeability, owing to the fact that neither systemic toxicity nor relevant irritating effects were observed. This is in accordance with the physico-chemical properties of the test substance. Oral resorption of the test substance is probably also restricted due to the low log Pow of < - 2 since most substances with a log Pow < 0.5 are only marginally resorbed. However, after oral gavage, the test substance is at least partially absorbed. This can be concluded from substance related organ discolorations (skin and kidneys) observed in the sub-acute toxicity study using high doses. As the test substance is consisted of molecules with azo structures, partial metabolic cleavage by bacterial azo-reductases in the intestine resulting in more hydrophilic amines seems to be likely. After resorption following oral administration, reversible distribution in skin and kidneys is possible as demonstrated by test substance related discolorations, which were reduced after a 14 d recovery period. In the histopathological examination no correlation (e.g. precipitate) for this discoloration was detected, confirming its reversibility. Reddish discolored feces after oral administration of the test substance indicated that the compound is predominantly eliminated via the intestine. This corresponds to the fact that substances with a molecular weight above 300 g/mol are preferentially excreted via the feces in rats. Red or dark yellow discolored urine however showed that test substance elimination also occurs via kidneys/urine.

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