Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Remarks:
Light yellow solid (powder)

In vitro test system

Details on study design:
Main study
Day 1:
Each animal was identified and the body weight was recorded. To the dorsum of each ear, 25µL of the appropriate dilution of the test item, or the vehicle alone was applied.
Days 2 and 3:
The application procedure carried out on day 1 was repeated.
Days 4 and 5: No treatment.
Day 6:
The body weight of each animal was recorded. 250µL of sterile phosphate-buffered saline (PBS) containing 2 µCi (7.4 x 104 Bq) of 125I-iododeoxyuridine and 10-5M fluorodeoxyuridine was injected into all test and control mice via the tail vein.
Five hours later, the animals were sacrificed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each experimental group (pooled treatment group approach).

Results and discussion

In vitro / in chemico

Results
Parameter:
other: Stimulation Indices (SI)
Value:
< 3
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The reliability of experimental technique used was performed with five females, using α-Hexylcinnamaldehyde (positive control) as a part of the study.
The same procedure as on treated as well ascontrol animals was used. The pilot study was not realised due to the fact that the used substance (α-Hexylcinnamaldehyde) is well known.

Any other information on results incl. tables

The Lymph node weight, DPM, SI, EC3 values.

 

Lymph node

Number of

 

 

 

 

weight (g)

lymph nodes

DPM

SI

EC3 (%)

Control

0.0410

10

940.8

-

-

 

Positive Control

0.0617

10

5735.3

8.20*

Chiguard GA403   25%

 

0.0394

10

1166.5

1.24

Chiguard GA403   50%

 

0.0355

10

906.3

0.96

Chiguard GA403   100%

 

0.0418

10

1093.5

1.16

*Calculated with corresponding control value of 699.3 DPM

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitizing potential of Chiguard GA403 was assessed using the murine local lymph node assay.
Based on the results of this study, Chiguard GA403 is not considered a skin sensitizer under the condition of this LLNA study.