Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18.09.2007 - 20.10.2007
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Formula: C12H14ClN5O4
Appearance: White to pale yellow solid
Expiry date: 31 December 2007

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
(low dose): 5% (w/w) test substance
(mid dose): 10% (w/w) test substance
(high dose): 21.9% (w/w) test substance
No. of animals per dose:
3 goups of 5 fenale per dose

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: group K (negative control) SI: 1 group A (low dose) SI: 1.4 group B (mid dose) SI: 2.0 group C (high dose) SI: 3.2 group P (positive control) SI: 9.5
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: group K (negative control) DPM: 2948 group A (low dose) DPM: 4251 group B (mid dose) DPM: 5953 group C (high dose) DPM: 9289 group P (positive control) DPM: 28043

Any other information on results incl. tables

The positive control substance led to a stimulation index of 9.5, thus demonstrating the validity of the experiment.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the OECD-Guideline 429 and the REGULATION (EC) No 1272/2008., "Fam-stage-1" is regarded as a sensitiser in the LLNA.