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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in chemico
Remarks:
DPRA
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
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))
GLP compliance:
yes
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

In chemico test system

Details on study design:
Reference items:
-Positive control: cinnamaldehyde
-Co-elution control: test item in the appropriate buffer
-4 references:
*Reference control A: prepared with acetonitrile in order to check the calibration curve accuracy,
*Reference control B: prepared with acetonitrile and included at the beginning and at the end of the sequence in order to check the stability of peptide over time,
*Reference control C: prepared with acetonitrile, the positive control solvent, in order to check its influence on the peptide stability
*Reference control C’: prepared with sterile water, the test item solvent, in order to check its influence on the peptide stability

The test item was prepared at 100 mM in sterile water and the positive control was prepared at 100 mM in acetonitrile. They were incubated in excess with the peptides at 1:10 and 1:50 ratio for cysteine and lysine peptides respectively. Each sample was tested 3 times from 3 independent solutions. HPLC analysis started 24 hours ± 2 hours after addition of peptides.

Results and discussion

Positive control results:
For cinnamaldehyde, the mean depletion in lysine peptide was 55.31% and the mean depletin in cysteine peptide was 73.06%.

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: depletion in lysine peptide (%)
Run / experiment:
mean
Value:
ca. 1.35
Positive controls validity:
valid
Key result
Parameter:
other: depletion in cysteine peptide (%)
Run / experiment:
mean
Value:
ca. 0.79
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The sensitivity of the test item is determined by calculating the mean percentage of depletion of Lysine and Cysteine.
The test item, 2-AMINOETHANOL HYDROBROMIDE, shows mean depletion of 1.35% for Lysine and 0.79% for Cysteine, i.e. an overall average of 1.07% reflecting no or a minimal reactivity and thus a negative prediction for the DPRA.

The test method DPRA is considered scientifically valid to be used as part of an integrated approach to testing and assessment, to support the identification of the sensitization potential of test item for hazard classification and labeling purposes.