Registration Dossier

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:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
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.