Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vivo
Adequacy of study:
other information
Study period:
From 29 NOV 2012 to 31 JAN 2013

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide
EC Number:
269-389-4
EC Name:
N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide
Cas Number:
68227-78-1
Molecular formula:
C32H25ClN4O4
IUPAC Name:
N-(5-chloro-2-methylphenyl)-3-hydroxy-4-{[2-methoxy-5-(phenylcarbamoyl)phenyl]diazenyl}-2-naphthamide

Administration / exposure

Duration of treatment / exposure:
single exposure
Frequency of treatment:
once
Post exposure period:
The animals were examined for acute toxic symptoms at intervals of approx. 1 h, 2 h and 4 h for the 4 hours treatment, and 1 h, and 16 h for the 16 hours treatment after administration of the test item.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 2000 mg/kg b.w.
Basis:

No. of animals per sex per dose:
2 males and 2 females were used in the pre-experiment
32 males were used in the main experiment, 4 males per dose and exposure time
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
liver
hepatocytes
Statistics:
A statistical evaluation of the results was not necessary to perform as the number of net grain counts of the groups treated with the test item were in the range of the corresponding controls.

Results and discussion

Applicant's summary and conclusion