Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
other: sterile water
Concentration:
10, 25, 50 % (w/w)
No. of animals per dose:
4

Results and discussion

Any other information on results incl. tables

Local irritation :

A discrete erythema was observed at D3 on both ears in one animal, on the left ear or on the right ear

of two other animals and at D6 on the right ear in one animal with test item Sesbania grandiflora dry

purified extract 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. Consequently, the EC3 value for the test item Sesbania

grandiflora dry purified extract can not be calculated. Summary results is presented in the following

Table Study results - Sesbania

Groups Treatment/concentrations Viability Amount of cells Cellularity index Stimulation index EC3value Increase in ear thickness

1 Vehicle 77% 2.4 1 1 NA +1%

2 Sesbania - 50% 79% 2.1 0.87 0.9 NA +3%

3 Sesbania - 25% 68% 1.3 0.54 1 NA -4%

4 Sesbania - 10% 70% 1.6 0.68 0.7 NA -2%

5 Acetone 84% 1.4 1 1 NA -9%

6 DNCB - 0.5% 91% 10.5 7.77 5.4 NA +2%

NA = not applicable

Viability = (amount of viable cells / amount of total cells) x 100

Amount of cells (106 cells per node)

Increased in ear thickness (% between day 1 and day 6)

cellularity index = (amount of cells x 106 in the treated group) / (amount of cells x 106 in the vehicle group)

Stimulation index = (mean optical density in the treated group) / ( mean optical density in the vehicle group)

EC3 value = theoretical concentration resulting in a SI value of 3

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the experimental conditions adopted, the test item Sesbania grandiflora dry purified extract in sterile water did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay using CBA female mice after three consecutive days of treatment.