Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: assessment from available information
Adequacy of study:
key study
Study period:
2017 - 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
assessment from available information
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder
Details on test material:
Batch No.: 7012/2007
Appearance: brown powder
Composition of test substance:
Main component:
2-(4-aminoanilino)-5-nitrobenzenesulphonic acid 5.5 area %

4-[[2,4-dihydroxy-3,5-bis[[4-(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-5-
hydroxynaphtalen-2,7-disulphonate, sodium salts 13.9 area %

4-[[2,4-dihydroxy-3-[(4-methoxyphenyl)azo]-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-
5-hydroxynaphthalene-2,7-disulphonate, sodium salts 42.4 area %

4-[[2,4-dihydroxy-3,5-bis[(4-methoxyphenyl)azo]phenyl]azo]-5-
hydroxynaphthalene-2,7-disulphonate, sodium salts 18.2 area %
Radiolabelling:
no

Results and discussion

Applicant's summary and conclusion

Conclusions:
According to current valid guidance the test substance with the result of LD50 in acute oral test higher than 2000 mg/kg is considered as non-toxic after single oral application. Acid Brown 235 did not penetrate into the organism through the skin after single application.
The test substance is considered to be non-irritating to the eye and skin of rabbit.
The test substance elicited negative sensitising response in mice.
According to results of acute exposition of the test substance Acid Brown 235 can be expected, that the test substance did not penetrate through the skin and digestive tract after single administration.
The test substance has not systemic toxic effect after repeated oral administration.
Test substance did not influenced reproduction parameters of males and females. Development of pups was not influenced by the test substance administration.
Results recorded during the reproduction part of study with repeated oral administration showed that the test substance did not penetrate into the testes and through the placental barrier.
No data about metabolism and excretion of the test substance were found.