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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
other: in vitro DPRA
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 February 2014 to 19 February 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to draft OECD test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draft OECD 13Nov2013
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
other: DPRA

Test material

Constituent 1
Chemical structure
Reference substance name:
D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates
EC Number:
941-129-0
Molecular formula:
C15H28O7 - C25H46O7
IUPAC Name:
D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates
Test material form:
other: yellowish thick liquid
Details on test material:
- Physical state: yellowish thick liquid
- Purity: 100%
- Expiration date of the lot/batch: 01 December 2014
- Storage condition of test material: room temperature and protected from light

Results and discussion

Positive control results:
The positive control substance induced a mean depletion rate of 60.47%.

In vitro / in chemico

Resultsopen allclose all
Key result
Run / experiment:
mean
Parameter:
other: Cysteine peptide depletion
Value:
0
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation
Key result
Run / experiment:
mean
Parameter:
other: Lysine peptide depletion
Value:
0
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Acceptance criteria were as per the draft OECD guideline.

Classification criteria for direct peptide reactivity were as per the draft OECD guideline.

Results for the test item and the positive control are presented in attached Tables 1 and 2, respectively. The peak areas for calibration curve samples are presented in attached Tables 3.1 and 3.2, the peptide concentrations and peak areas in reference control samples are presented in attached Tables 4.1 and 4.2. Representative chromatograms of the co-elution, reference control C and test item samples are presented for each peptide in attached Figures 1 to 6. The acceptance criteria for the calibration curve samples, the reference and positive controls as well as for the study samples were satisfied. The study was therefore considered to be valid. Analysis of the chromatograms of the co-elution samples (Figures 1 and 4) indicated that the test item did not co-elute with either the lysine or the cysteine peptides. As a result, the mean percent depletion values were calculated for each peptide using the formula described in § Data analysis and calculation. For both cysteine and lysine peptides, the mean depletion values were set to 0% since the individual percent depletion values were negative. The mean of the percent cysteine and percentage lysine depletions was therefore equal to 0%. Accordingly, the test item was considered to have no/minimal peptide reactivity.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other:
Conclusions:
Under the experimental conditions of this study, the test item, has 0% peptide reactivity.
Executive summary:

Introduction

The objective of the Direct Peptide Reactivity Assay (DPRA) was to evaluate the reactivity of the test item to synthetic cysteine and lysine peptides for skin sensitization assessment.

Methods

The reactivity of the test item was evaluated in chemico by monitoring peptide depletion following a 24-hour contact between the test item and synthetic cysteine and lysine peptides. The method consisted of the incubation of a diluted solution of cysteine or lysine with the test item for 24 hours. At the end of the incubation, the concentrations of residual peptides were evaluated by HPLC with Ultra-Violet detection at 220 nm. Peptide reactivity was reported as percent depletion based on the amount of peptide remaining in the sample relative to the average amount measured in the relevant reference control.

Results

Solubility assay

The test item was found soluble at 50 mg/mL in water obtained by reverse osmosis. Therefore, water obtained by reverse osmosis was selected as vehicle.

Direct Peptide Reactivity Assay

The acceptance criteria for the calibration curve samples, the reference and positive controls as well as for the study samples were satisfied. The study was therefore considered to be valid. Analysis of the chromatograms of the co-elution samples indicated that the test item did not co-elute with either the lysine or the cysteine peptides. As a result, the mean percent depletion values were calculated. For both cysteine and lysine peptides, the mean depletion values were set to 0% since the individual percent depletion values were negative. The mean of the percent cysteine and percent lysine depletions was therefore 0%. Accordingly, the test item was considered to have no/minimal peptide reactivity.

Conclusion

Under the experimental conditions of this study, the test item, has 0% peptide reactivity