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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No deviation from OECD-429 guideline, GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

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
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (non-LLNA)

Positive control substance(s):
no

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Remarks:
CAS No 68-12-2
Concentration:
5%, 10%, 25% solution in DMF
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 5%: 0.68 10%: 1.24 25%: 1.00
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 5%: 87.6 dpm / node 10%: 159.4 dpm / node 25%: 128 dpm / node

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mouse local lymph node assay (LLNA) Stimulation Index is below or equal to 1.24, this value is clearly under the threshold value 3, so conclusion is clearly that Appyclean-6505 is not skin sensitising.