trisodium 3-amino-4-[4-[4-(2-(2-ethenylsulfonylethoxy)ethylamino)-6-fluoro-1,3,5-triazine-2-ylamino]-2-sulfophenylazo]-5-hydroxynaphthalene-2,7-disulfonate

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics, other

Type of information:

other: Assessment

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Objective of study:

other: Assessment of toxicokinetic behaviour

GLP compliance:

no

FAT 40574/B has been tested for acute toxicity by oral and dermal application, for subacute toxicity by oral application and for irritant effects on skin and eyes and contact sensitization. Tests for mutagenicity have been performed in vitro without direct relevance for toxicokinetics. In the test for acute oral and dermal toxicity in rats FAT 40574/B has been applied at a dose level of 2000 mg/kg body weight. In a 28-days study FAT 40574/B was applied to rats by gavage at dose levels of 0, 50, 200 and 1000 mg/kg body weight daily. This resulted in no severe toxic effects. [NOAEL: 200 mg/Kg/body weight]. With a water solubility of >200 g/l and a log Pow of -4.0, the substance shows a low bio-availability. This statement is also confirmed by results of acute testing. Also in the 28 days-subacute test we find by obvious leak of toxic behaviour pure hints on gastrointestinal resorption followed by distribution. An inhalative exposition may be fully excluded based on the particle distribution of final sales form. The notified substance is a powder without significant respirable fraction as the potential dust is treated during manufacturing in closed system with antidusting compound and therefore a dust-free sales form is introduced into the market.

Conclusions:

With a water solubility of >200 g/l and a log Pow of minus 4.0 c, the substance shows a low bio-availability. This statement is also confirmed by results of acute testing. Also in the 28 days-subacute test we find by obvious leak of toxic behaviour pure hints on gastrointestinal resorption
followed by distribution. An inhalative exposition may be fully excluded based on the particle distribution of final sales form. The notified substance is a powder without significant respirable fraction as the potential dust is treated during manufacturing in closed system with dedusting compound and therefore a dust-free sales form is introduced into the market.

Executive summary:

FAT 40574/B has been tested for acute toxicity by oral and dermal application, for subacute toxicity by oral application and for irritant effects on skin and eyes and contact sensitization. Tests for mutagenicity have been performed in vitro without direct relevance for toxicokinetics. In the test for acute oral and dermal toxicity in rats FAT 40574/B has been applied at a dose level of 2000 mg/kg body weight. In a 28-days study FAT 40574/B was applied to rats by gavage at dose levels of 0, 50, 200 and 1000 mg/kg body weight daily. This resulted in no severe toxic effects. [NOAEL: 200 mg/kg/body weight]. With a water solubility of >200 g/l and a log Pow of -4.0, the substance shows a low bio-availability. This statement is also confirmed by results of acute testing. Also in the 28 days-subacute test we find by obvious leak of toxic behaviour pure hints on gastrointestinal resorption followed by distribution. An inhalative exposition may be fully excluded based on the particle distribution of final sales form. The notified substance is a powder without significant respirable fraction as the potential dust is treated during manufacturing in closed system with antidusting compound and therefore a dust-free sales form is introduced into the market.

Description of key information

FAT 40574/B has been tested for acute toxicity by oral and dermal application, for subacute toxicity by oral application and for irritant effects on skin and eyes and contact sensitization. Tests for mutagenicity have been performed in vitro without direct relevance for toxicokinetics. In the test for acute oral and dermal toxicity in rats FAT 40574/B has been applied at a dose level of 2000 mg/kg body weight. In a 28-days study FAT 40574/B was applied to rats by gavage at dose levels of 0, 50, 200 and 1000 mg/kg body weight daily. This resulted in no severe toxic effects. [NOAEL: 200 mg/kg/body weight]. With a water solubility of >200 g/l and a log Pow of -4.0, the substance shows a low bio-availability. This statement is also confirmed by results of acute testing. Also in the 28 days-subacute test we find by obvious leak of toxic behaviour pure hints on gastrointestinal resorption followed by distribution. An inhalative exposition may be fully excluded based on the particle distribution of final sales form. The notified substance is a powder without significant respirable fraction as the potential dust is treated during manufacturing in closed system with antidusting compound and therefore a dust-free sales form is introduced into the market.