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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
direct peptide reactivity assay (DPRA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Salt of N-acetyl-L-glutamic acid and 1-[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methanamine (1:1), monohydrate
EC Number:
922-576-0
Cas Number:
1184182-45-3
Molecular formula:
C18H28N2O8
IUPAC Name:
Salt of N-acetyl-L-glutamic acid and 1-[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methanamine (1:1), monohydrate
Test material form:
solid: particulate/powder

In chemico test system

Details on the study design:
Solutions of DEXGLUTACYCLE were successfully analyzed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. With minimal (Cysteine) and no depletion (Lysine) of either peptide (an overall mean depletion 0.15% was achieved) in the presence of DEXGLUTACYCLE

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Run / experiment:
other: Cysteine
Parameter:
other: Mean peptide depletion by DEXGLUTACYCLE (%)
Remarks:
The DPRA prediction and the reactivity of DEXGLUTACYCLE based on the overall mean and the individual depletion values in the Cysteine peptide and the Lysine peptide
Value:
0.3
Key result
Run / experiment:
other: Lysine
Parameter:
other: Mean peptide depletion by DEXGLUTACYCLE (%)
Remarks:
The DPRA prediction and the reactivity of DEXGLUTACYCLE based on the overall mean and the individual depletion values in the Cysteine peptide and the Lysine peptide
Value:
-0.781

Applicant's summary and conclusion

Interpretation of results:
other: no reactivity in either peptide therefore the prediction is a non-sensitiser
Conclusions:
Solutions of DEXGLUTACYCLE were successfully analysed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. There was minimal reactivity in the cysteine peptide and no reactivity in the Lysine peptide so DEXGLUTACYCLE with a mean depletion value of 0.15% is placed in the reactivity class of “no or minimal” and hence it is predicted by DPRA not to be a skin sensitizer.