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Administrative data

basic toxicokinetics
Type of information:
other: Assessment
Adequacy of study:
key study
1 (reliable without restriction)

Data source

Reference Type:
other: SNIF

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Hill formula: C25 H22 F N8 Na3 O13 S4 CAS formula: C25 H25 F N8 O13 S4 · 3 Na
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

Results and discussion

Any other information on results incl. tables

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


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


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 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 antidusting compound and

therefore a dust-free sales form is introduced into the


Applicant's summary and conclusion

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