Registration Dossier
Registration Dossier
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EC number: 444-850-4 | CAS number: 1235390-87-0
Skin sensitisation
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:
- 2 013
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
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.
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