Registration Dossier
Registration Dossier
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EC number: 215-833-7 | CAS number: 1423-46-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- January 26, 2015 to January 30, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- The Cosmetic directive is phasing out of animal testing for new products. This has led to the
development of potential alternative assays to screen for sensitizing potential. These new assays
were tested against a large list of reference chemicals in order to prove their applicability domain.
The Direct peptide reactivity Assay (DPRA) is an in chemico test to determine the reactivity of test
substances towards peptides.
Test material
- Reference substance name:
- Isocyclocitral Tech
- IUPAC Name:
- Isocyclocitral Tech
- Test material form:
- other: liquid
- Details on test material:
- - Trivial name: Isocyclocitral Tech
- Chemical Name: 3-Cyclohexene-1-carboxaldehyde, 2,4,6-trimethyl-
- Physical state: liquid
- Analytical purity: 95.7 %
- Supplier: Givaudan Schweiz AG
- Lot/batch No.: VE00154585
- Expiration date of the lot/batch: 04.03.2016
- Supplier: Givaudan Schweiz AG
Constituent 1
In chemico test system
- Details on the study design:
- The Lys-peptide Ac-RFAAKAA is incubated at a final concentration of 0.5 mM in an ammonium
acetate buffer at pH 10.5 in presence of a final level of 25% acetonitrile and in presence of a 50-fold
excess of the test substance (25 mM) dissolved in acetonitrile.
The Cys-peptide Ac-RFAACAA is incubated at a final concentration of 0.5 mM in phosphate buffer
at pH 7.5 in presence of a final level of 25% acetonitrile and in presence of a 10-fold excess of the
test substance (5 mM) dissolved in acetonitrile.
24 h after start of the incubation the remaining peptide is quantified with HPLC-UV.
In vivo test system
Test animals
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Not applicable.
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- Not applicable
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Run / experiment:
- other: Cys-peptide depletion
- Value:
- 23
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Run / experiment:
- other: Lys-peptide depletion
- Value:
- 51
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
- Acceptance criteria met for positive control:
Cys-peptide depletion: 60.8 – 100%
Lys-peptide depletion: 40.2- 69.4%
- Acceptance criteria met for variability between replicate measurements:
Cys-peptide depletion: coefficient of variation < 14.9
Lys-peptide depletion: coefficient of variation < 11.6
Any other information on results incl. tables
Average Standard deviation Cys-peptide depletion 25.5 2.2 Lys-peptide depletion 52.0 0.2 Average depletion Cys-and Lys-peptide 38.7 Reactivity Class MODERATE Prediction Sensitizer Elution time Cys peptide 10.7 Elution time test substance Cys peptide run 15 / 15.8 (2 Peaks) Elution time Lys peptide 8.12 Elution time test substance Lys peptide run 15 / 15.8 (2 Peaks)
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Key Study is used for classification
- Conclusions:
- ISOCYCLOCITRAL TECH was reactive and classified into the MODERATE reactivity class according to the prediction model. It is therefore considered a sensitizer according to the prediction model of the DPRA.
- Executive summary:
ISOCYCLOCITRAL TECH was reactive and classified into the MODERATE reactivity class according to the prediction model. It is therefore considered a sensitizer according to the prediction model of the DPRA.
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