Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15.01.2008 to 06.07.2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study report

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (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
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Species: Mouse, CBA strain, inbred, SPF-Quality. Recognized by the international guidelines as the recommended test system (e.g. OECD, EC, EPA).
Source: Charles River France, L' Arbresle Cedex, France
Number of animals: 30 females (nulliparous and non-pregnant), five females per group.
Age and bodyweight: Young adult animals (approx. 9-10 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean.
Identification: Tail mark with marker pen.
Health inspection: A health inspection was performed prior to treatment, to ensure that the animals are in a good state of health. Special
attention was paid to the ears, which were intact and free from any abnormality.
Reliability check: The results of a reliability test with Hexylcinnamaldehyde, performed not more than 6 months previously, are summarized in
the Appendix. Similar procedures were used in the reliability test and in this study.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
propylene glycol
Concentration / amount:
2.5, 5 and 10%
Challengeopen allclose all
Route:
other: no challenge conducted
Vehicle:
propylene glycol
Concentration / amount:
2.5, 5 and 10%
No. of animals per dose:
5

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
Group(1) animal numbers induction (% test substance)
1 01-05 0% (Propylen glycol)
2 06-10 2.5%
3 11-15 5%
4 16-20 10%
5 21-25 0% (Propylen glycol)
6 26-30 5%

(1) five females each group
No. of animals per dose:
30 females (nulliparous and non-pregnant), five females per group.
Details on study design:
Initially, three groups of five animals were treated with one test substance concentration per group. The highest test substance
concentration was selected from the preliminary irritation study. One group of five animals was treated with vehicle. Borderline results (SI close
to cutoff value of 3) were obtained for the initial group at 5%. In order to clarify the results at the 5% concentration, an additional group of
five animals was treated with a 5% concentration, along with a concurrent vehicle control group of five animals.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: look to "illustration (picture / graph)
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: look to "illustration (picture / graph)

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No skin reactions were observed in any of the animals examined.
In conclusion, the calculated mean Sl values for the substance concentrations 2.5 and 10% did not exceed Sl 2 3. Although the mean Sl value for theinitial 5% test substance concentration exceeded Sl 2 3, this result occurred in the absence of a dose response relationship and was not confirmediin an additional test. Therefore, DCM was considered to be a non skin sensitizer.