Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-10-28 to 2008-11-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD and GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
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:
dimethyl sulphoxide
Concentration:
0, 5, 10, 20 % (w/v)
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The obtained values are within the expected range.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 0 % (w/v) 5 % (w/v): 1.67 SI 10 % (w/v): 2.70 SI 20 % (w/v): 2.51 SI
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 0 % (w/v): 4968 DPM 5 % (w/v): 8272 DPM 10 % (w/v): 13364 DPM 20 % (w/v): 12433 DPM

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test item 2 -Benzimidazolon was not a skin sensitiser in this assay.
Executive summary:

In the study the test item 2 -Benzimidazolon dissolved in DMSO was assessed for its possible contact allergenic potential.

For this purpose a LLNA was performed using test item concentrations of 5, 10 and 20%.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.

In this study Stimulation Indices (S.I.) of 1.67, 2.70, and 2.51 were determined with the test item at concentrations of 5, 10 and 20% in DMSO, respectively.

The test item 2 -Benzimidazolon was not a skin sensitiser in this assay.