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EC number: 951-622-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5th Feb 2019 to 25th Feb 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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 substance name:
- cis-N-hydroxy-3-[methyl(1H-pyrrolo[2,3-d]pyrimidin- 4-yl)amino]cyclobutanecarboxamide
- EC Number:
- 951-622-2
- Molecular formula:
- C12H15N5O2
- IUPAC Name:
- cis-N-hydroxy-3-[methyl(1H-pyrrolo[2,3-d]pyrimidin- 4-yl)amino]cyclobutanecarboxamide
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- 20 Females (nulliparous and non-pregnant). Five females per group. Age at the Initiation of Dosing: Young adult animals (approximately 12 weeks old) were selected.
Target temperatures of 18 to 24°C with a relative target humidity of 40 to 70% were maintained. The actual daily mean temperature during the study period was 22°C with an
actual daily mean relative humidity of 42 to 47%. A 12-hour light/12-hour dark cycle was maintained. Ten or greater air changes per hour with 100% fresh air (no air recirculation)
were maintained in the animal rooms.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0%, 5%, 10%, 25%
- No. of animals per dose:
- 5
- Details on study design:
- Three groups of five animals were treated with one test item concentration per group. The highest test item concentration was selected from the pre-screen test. One group of five
animals was treated with the vehicle.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1
- Variability:
- +/- 0.1
- Test group / Remarks:
- 0%
- Remarks on result:
- other: Vehicle Control
- Key result
- Parameter:
- SI
- Value:
- ca. 1.2
- Variability:
- +/-0.3
- Test group / Remarks:
- 5%
- Remarks on result:
- not determinable
- Remarks:
- No indication of skin sensitisation was detected
- Key result
- Parameter:
- SI
- Value:
- ca. 1.2
- Variability:
- +/-0.1
- Test group / Remarks:
- 10%
- Remarks on result:
- not determinable
- Remarks:
- No indication of skin sensitisation was detected
- Key result
- Parameter:
- SI
- Value:
- ca. 0.9
- Variability:
- +/-0.1
- Test group / Remarks:
- 25%
- Remarks on result:
- not determinable
- Remarks:
- No indication of skin sensitisation was detected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since there was no indication that the test item elicits a SI ≥ 3 when tested up to 25%, PF07085579 was not considered to be a skin sensitizer.
It was established that the EC3 value (the estimated test item concentration that will give a SI =3) (if any) exceeds 25%. The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at Charles River Den Bosch is an appropriate model for testing for contact hypersensitivity. Based on these results, PF-07085579 would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines. The test item does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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