Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 October to 5 November 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in accordance with recognised test method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): PF-00346643
- Substance type: pure substance
- Physical state: pale yellow oil
- Analytical purity: 88.9%
- Lot/batch No.: 115565-67-1
- Expiration date of the lot/batch: 31 January 2008
- Stability under test conditions: stable
- Storage condition of test material: in a refrigerator (2-8°C)
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, 100%
- No. of animals per dose:
- 5
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the substance concentrations 25, 50 and 100% were 9.0, 19.9 and 34.5 respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 1942, 4303 and 7464 respectively. The mean DPM/animal value for the vehicle control group was 216.
Any other information on results incl. tables
Preliminary irritation study
Based on the results of the epidermal exposures,
the highest test substance concentration selected for the main study was a 100% concentration.
Main study
No irritation was observed in the control animals and the animals treated at 10%. The irritation of the ears as shown by the animals treated at 50% and 100% was considered not to have a toxicologically significant effect on the activity of the nodes.
Enlarged nodes were seen in the experimental groups. The frequency and size increased with increasing dose level. No macroscopic abnormalities of the surrounding area were noted.
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
See background information section for detailed results tables.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- PF-00346643 is regarded as a sensitiser.
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