Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guiudeline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Principles of method if other than guideline:
The modified Local Lymph Node Assay (IMDS) was performed on 24 female NMRI mice of the strain Crl:NMRI BR (6 animals/test item group and 6 control animals) to determine if there is any specific (sensitizing) or non-specific (irritant) stimulating potential of the test item Glebpigment E4GN.
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test item:Gelbpigment E4GN

In vivo test system

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
Group 1Vehicle (DMF)Group 2 2% Gelbpigment E4GN (in DMF) Group 310% Gelbpigment E4GN (in DMF)Group 450% Gelbpigment E4GN (in DMF)Group 530% Alpha Hexyl Cinnamic Aldehyde (in DMF)
No. of animals per dose:
6 animals/test item group and 6 control animals

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
A modified Local Lymph Node Assay (IMDS) was carried out in mice. The modifications refer to the measurement of cell proliferation by cell counting instead of radioactive labeling. In addition, the acute inflammatory skin reaction is determined to discriminate specific from non-specific activation of immune competent cells in the draining lymph nodes, as also recommend in the update of OECD TG 429. 1. Direct LLNA (NMRI mice, female, 6 animalsl group) Groups Weight index Cell count index (index of mean +/-SD in %) Gr.l 1.00 +/-4.58 1.00 +/-10.50 Gr.2 0.83 +/-11.46 1.78 +/-14.11 Gr.3 0.89s +/-16.13 0.77s +/-21.44 Gr.4 1.05 +/-20.34 0.93 +/-16.72 Gr. 5 1.21 +/-17.75 1.45 +/-21.48 Ear swelling (NMRI mice, female, 6 animals/group, in 0.01 mm) Groups day 1 day4 Index day4 (mean +/- SD in %) Gr. 1 17.25 +/- 2.62 17.67 +/- 2.79 1.00 Gr.2 17.42 +/- 2.96 17.92 +/-2.87 1.01 Gr. 3 17.33 +/- 4.49 18.33 +/- 5.37 1.04 Gr. 4 17.92 +/- 3.73 22.92s +/- 15.95 1.30 Gr. 5 17.83 +/- 4.02 23.67s+/- 13.03 1.34 Ear weight (NMRI mice, female, 6 animals/group, in mg per 8 mm diameter punch) Groups day4 Index day4 (mean +/- SD in %) Gr.1 12.13 +/- 4.59 1.00 Gr.2 11.98 +/- 6.75 0.99 Gr.3 13.06 +/- 8.10 1.08 Gr.4 14.11s +/- 9.19 1.16 Gr.5 14.88 +/- 14.75 1.23 s = statistically significant Group 1Vehicle (DMF) Group 2 2% Gelbpigment E4GN (in DMF) Group 310% Gelbpigment E4GN (in DMF) Group 450% Gelbpigment E4GN (in DMF) Group 530% Alpha Hexyl Cinnamic Aldehyde (in DMF)
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: not applicable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Mice were treated with vehicle, 2 %, 10 % or 50 % Gelbpigment E4GN in DMF.

The NMRI mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test item Gelbpigment E4GN.

The “positive level”, which is 1.4 for the cell count index, was never reached or exceeded in any dose group.

These findings were verified by the results obtained with the positive control compound Alpha Hexyl Cinnamic Aldehyde.