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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in chemico
Remarks:
Direct Peptide Reactivity Assay (DPRA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Mar 2018 to 05 Apr 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Version / remarks:
OECD Guideline for the Testing of Chemicals, Guideline 442C. In Chemico Skin
Sensitization: Direct Peptide Reactivity Assay (DPRA) (4 February 2015)
Deviations:
no
GLP compliance:
yes
Type of study:
other: Direct Peptide Reactivity Assay (DPRA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Purity 99.73%

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Parameter:
other: mean Percent SPCC Depletion for the test item
Run / experiment:
Cysteine Reactivity Assay
Value:
ca. 66.5
Parameter:
other: mean Percent SPCL Depletion for the Test Item
Run / experiment:
Lysine Reactivity Assay
Value:
ca. 4.2
Parameter:
other: DPRA prediction and reactivity classification
Run / experiment:
Cysteine 1:10 / Lysine 1:50 prediction model
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
In conclusion, this DPRA test is valid. PF-06961030 was positive in the DPRA and was classified in the “moderate reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model