Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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