Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Principles of method if other than guideline:
Test procedure:
Strain: CBA/J Rj.mouse

A preliminary study was performed in order to defined the
maximum concentration causing slight to moderate irritation
by cutaneous application of the test item Sesbania
grandiflora dry purified extract.

In the main study, 24 female CBA/J mice were allocated to
the following six groups:

• one vehicle group of four animals receiving the vehicle
(sterile water),

• three treated groups of four animals receiving the test
item Sesbania grandiflora dry purified extract at the
concentration of 10% (w/w), 25% (w/w) or 50% (w/w),

• one vehicle positive group of four animals receiving the
vehicle of the positive control substance(acetone),

• one positive control group of four animals receiving 2,4-
dinitrochlorobenzene (DNCB) at theconcentration of 0.5% in
acetone.

Results and discussion

Details on results:
No mortality and no clinical signs were observed during the
main study.

Local irritation :

A discrete erythema was observed at D3 on both ears in one
animal, on the left ear or right ear of two other animals
and at D6 on the right ear in one animal with test item at
50% (w/w) in sterile water.

No increase in cellularity index or in amount of the cells
was observed at D6 in comparison with D1.

No significative increase in ear thickness was noted in
animals treated with Sesbania 25% and 10%.

In animals treated with Sesbania 50%, a significative
increase in ear thickness (+11%) was observed at D3 that it
is related to the slight irritation. At D6, ear thickness
was equivalent in comparison with D1, but the difference was
significative in comparison in ear thickness of vehicle
which was weaker.

Lymphoproliferative effect:

The test item Sesbania grandiflora dry purified extract,
whatever the dose tested, did not produce a stimulation
index equal or greater than 3.


The test item did not induce delayed contact
hypersensitivity in the murine Local Lymph Node Assay using
CBA female mice after three consecutive days of treatment.

Applicant's summary and conclusion