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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.