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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in chemico
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
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
GLP compliance:
yes
Type of study:
other: direct peptide reactivity assay (DPRA test)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihydro-5-octylfuran-2(3H)-one
EC Number:
218-971-6
EC Name:
Dihydro-5-octylfuran-2(3H)-one
Cas Number:
2305-05-7
Molecular formula:
C12H22O2
IUPAC Name:
Dihydro-5-octylfuran-2(3H)-one
Specific details on test material used for the study:
6.1 Test Item
Designation in Test Facility: 17092503G
Date of Receipt: 25. Sep. 2017
Condition at Receipt: Room temperature, in proper conditions
6.1.1 Specification
The following information concerning identity and composition of the test item was provid-ed by the sponsor.
Name gamma-Dodecalactone
Batch no. 050170905
Appearance clear, colorless liquid
Composition gamma-Dodecalactone
CAS No. 2305-05-7
EINECS-No. 218-971-6
Molecular formula C12H22O2
Molecular weight 198.3 g/mol
Purity 99.02 %
Homogeneity homogeneous
Vapour pressure unknown
Stability H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility H2O: unknown; EtOH: 0.1 - 1 g/L; acetone: unknown; CH3CN: unknown; DMSO: unknown
Production date 19. Sep. 2017
Expiry date 18. Sep. 2018
Storage Room Temperature (20 ± 5°C)
6.1.2 Storage
The test item was stored in a closed vessel at room temperature (20 ± 5 °C).

In chemico test system

Details on the study design:
Peptides with ≥ 95 % purity, synthesized by Genecust, Dudelange, Luxemburg, were used.
6.3.1 Cys-Peptide (Cysteine)
Sequence: Ac-RFAACAA-COOH (MW = 750.9 g/mol)
Batch no.:P170415-2-LR569638
Purity: 98.10 %
6.3.2 Lys-Peptide (Lysine)
Sequence: Ac-RFAAKAA-COOH (MW = 775.9 g/mol)
Batch no.: P170415-2-LR569640
Purity: 98.85 %

Results and discussion

Positive control results:
a)The mean peptide depletion and standard deviation of the three replicates of the positive control cinnamaldehyde were in the acceptable range of 60.8 – 100.0 % and ≤ 14.9 %, respectively, for the Cys-peptide.
b)The mean peptide depletion and standard deviation of the three replicates of the positive control 2,3-Butanedione were in the acceptable range of 10.0 – 45.0 % and ≤ 11.6 %, respectively, for the Lys-peptide.

In vitro / in chemico

Results
Key result
Parameter:
other: Mean peptide depletion [%]
Value:
1.03
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mean peptide depletion in the Lys-peptide and Cys-peptide assay was 1.03 %, there-fore the test item was classified with:
DPRA Prediction: Negative
Reactivity class: Minimal

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