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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse ear swelling test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
465-070-0
EC Name:
-
Cas Number:
518048-03-8
Molecular formula:
C16H19FN403
IUPAC Name:
2-(1-amino-1-methylethyl)-N-(4-fluorobenzyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
Details on test material:
L-000900405-000M004

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/J
Sex:
female
Details on test animals and environmental conditions:
The mice were treated by topical application of the test article concentrations, vehicle or control to the dorsum of each ear once daily for three consecutive days.

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
2.5% - 5% - 10%
No. of animals per dose:
5
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The positive control, 25%HCA yielded a SI of 10.3, consistent with values obtained in the ICCVAM Validation Report.

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Treatment Stimulation Index DMSO - Vehicle : 1.0 25% HCA - Positive Control : 10.3 2.5% Test Article : 0.6 5% Test Article : 0.8 10% Test Article : 0.8 Note : a SI ≥ 3 indicates a sensitizing response.

Any other information on results incl. tables

Mean Number of Proliferating Cells in the Lymph Nodes of each Treatment Group

 Treatment  Vehicle  Mean cell # (x10e3)  % BrdU+  # BrdU+
 DMSO - Vehicle  -  2760  1.14  31298
 25% HCA - Positive control  DMSO  13092  2.52  321949
 2.5% Test Article  DMSO  2433  0.89  17497
 5% Test Article  DMSO  3601  0.71  25528
 10% Test Article  DMSO  3901  0.67  25119

The SI was calculated by dividing the mean number of proliferating lymph node cells# (BrdU+) from each Treatment Group by the mean number of proliferating cells from the DMSO Vehicle Group

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Topical application of the test article at 2.5%, 5%, and 10% resulted in a stimulation index less than 3 (SI ≤ 3.0), a negative result, and therefore this test article is not a dermal sensitizer in the Local Lymph Node Assay