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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
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

Constituent 1

In vivo test system

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals and environmental conditions:
SPF albino mice; strain: Crl:NMRI (Charles River Deutschland GmbH)

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
10%, 25%, 50%
No. of animals per dose:
6

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: 10%: 0.78 25%: 1.01 50%: 0.97

Any other information on results incl. tables

Treatment with the 10%, 25% and 50% test item did not cause a transgression of the positive threshold value concerning the lymph node cell count. Only at 50% test item, the positive threshold value concerning the index of the ear thickness was exceeded, however, a differentiation index of 0.00 was calculated. Therefore, no signs of an irritant and/or allergic effect were identified.

Applicant's summary and conclusion

Conclusions:
Neither a specific (sensitizing) nor a non-specific (irritant) stimulation potential shall be attributed to the test item.