4-amino-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-3-(2-sulfonato-4-(2-sulfonatooxyethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate potassium/sodium;reaction mass of: 4-amino-3-(4-ethenesulfonyl-2-sulfonatophenylazo)-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)naphthalene-2,7-disulfonate potassium/sodium

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: DIRECTIVE 93/67/EEC

GLP compliance:

no

Test material

Test material information

Constituent 1

Results and discussion

Any other information on results incl. tables

Toxicokinetics, metabolism and distribution

Risk assessment

The data presented in the present dossier only allow for a qualitative assessment of the toxicokinetic behaviour of the test item.

Physico-chemical data:

Blue TZ 4775 is a sodium salt of a reactive dye structure with relatively high molecular weight given into commercial/industrial use in a dedusted and high particle size sales form. For the dedusted sales form therefore generally a particle diameter of > 100 µm

can be assumed. The main component of the mixture has a purity of ca. 64.4 %. More than 400 g Blue TZ 4775 are soluble in water at 20 °C.

Toxicological data:

Blue TZ 4775 was tested for acute toxicity by oral and dermal application, for subacute oral toxicity and for irritant effects on skin and eyes as well as for skin sensitization in a maximisation assay.

In the tests for acute oral and dermal toxicity, Blue TZ 4775 was applied to rats at a single dose level of 2000 mg/kg body weight (oral) and 2000 mg/kg body weight (dermal). Neither mortality nor any substance-related systemic effects or changes on organs

were seen.

On skin irritation testing, Blue TZ 4775 produced a blue staining of the treated skin of rabbits by pigment or colouring of the test article in the area of application. According to EU-criteria the substance is not irritating to skin. The colouring of fur and skin may be

declared as usual/normal for the use of dyestuffs for natural fibres as cotton and/or wool.

On eye irritation testing, Blue TZ 4775 was found to generate irreversible blue stainings of the eyes. Accordingly the dye was classified as irritating to the eye of rabbits.

On skin sensitization testing, Blue TZ 4775 was found not to be a skin sensitizer.

Oral administration of Blue TZ 4775 including following recovery period, did not result in severe adverse effects/ findings. Neither deaths nor treatment related severe clinical signs were observed during the study. Based on the results of this study the "no

observed effect level" was determined with 200 mg per kg-body weight per day. Presumably the substance was relatively well resorbed from the gastrointestinal tract in animal tests without causing toxic effects. No other signs of substance resorption or excretion were seen in any available toxicity study.

Mutagenic effects did not occur in the Ames test and no clastogenic effects in a Chromosome aberration test in vitro with and without metabolic activation. No other indications on the toxicokinetic behaviour of FAT 40815/A (Blue TZ 4775) could be derived from the results of the available studies.

Absorption and metabolism:

With a water solubility of > 400 g/l and a very low log Pow, the substance indicates a low potential for passive absoption by diffusion through cell membranes including dermal absorption and a low bio-accumulation potential.

Distribution and excretion:

The substance and its 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.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
With a water solubility of > 400 g/l and a very low log Pow, the substance indicates a low potential for passive absoption by diffusion through cell membranes including dermal absorption and a low bio-accumulation potential.
The substance and its 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.