Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: Assessment based on physicochemical properties and available toxicological data
Adequacy of study:
key study
Study period:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
toxicokinetics
Principles of method if other than guideline:
Toxicokinetic assesment based on the available physicochemical and toxicological data as per the ECHA Guidance R.7c
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Trisodium 4-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)- 2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3- yl]diazenyl}benzenesulfonate
Cas Number:
106359-90-4
IUPAC Name:
Trisodium 4-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)- 2-{[1-ethyl-2-hydroxy-4-methyl-6-oxo-5-(sulfonatomethyl)-1,6-dihydropyridin-3- yl]diazenyl}benzenesulfonate
Test material form:
solid: particulate/powder
Details on test material:
None

Results and discussion

Applicant's summary and conclusion

Conclusions:
REACTIVE YELLOW 095 would be absorbed primarily in gastrointestinal tract, while limited absorption via dermal and inhalation exposure can be expected. Systemic distribution would most likely occur via the serum, while metabolism would be limited and not required to facilitate renal excretion.
Executive summary:

REACTIVE YELLOW 095 would be absorbed primarily in gastrointestinal tract, while limited absorption via dermal and inhalation exposure can be expected. Systemic distribution would most likely occur via the serum, while metabolism would be limited and not required to facilitate renal excretion.