Registration Dossier
Registration Dossier
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EC number: 903-139-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- A read-across justification is provided in the IUCLID chapter "assessment reports"
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
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 (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- A read-across justification is provided in the IUCLID chapter "assessment reports"
Test material
- Reference substance name:
- Pentan-1-ol
- EC Number:
- 200-752-1
- EC Name:
- Pentan-1-ol
- Cas Number:
- 71-41-0
- Molecular formula:
- C5H12O
- IUPAC Name:
- pentan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Pentanol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Tk287_20151217
- Expiration date of the lot/batch: 17.12.2016
- Purity test date: 20.04.2016
- Purity: 99.9%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: guaranteed by the sponsor
- Solubility and stability of the test substance in the solvent/vehicle: soluble, no analysis performed because the dissolved test substance was used shortly after preparation
In vitro test system
- Details on the study design:
- The test substance is incubated with synthetic peptides for 24 hours at room temperature in the dark. The remaining non-depleted peptide concentration is determined thereafter by high performance liquid chromatography with gradient elution and UV-detection at 220 nm.
The peptide depletion of test-substance incubated samples is compared to the peptide depletion of the NC samples and expressed as relative peptide depletion.
Synthetic peptides:
Cysteine- (C-) containing peptide:
Ac-RFAACAA-COOH (MW=751.9 g/mol)
Lysine- (K-) containing peptide:
Ac-RFAAKAA-COOH (MW=776.2 g/mol)
The peptides are custom material (Supplier: GenScript, Piscataway, NJ, USA and RS Synthesis, Louisville KY, USA) containing phenylalanine to aid in detection and either cysteine or lysine as the reactive center.
Concentrations:
C-peptide: 5mM test substance, 0.5mM peptide
K-peptide: 25mM test substance, 0.5mM peptide
Test substance preparations were prepared on a weight per volume basis within 4 hours of the start of the experiment.
No. of replicates: 3
Vehicle control: acetonitrile
Reason for vehicle: solubility
Positive control: Ethylene glycol dimethacrylate (50mM in acetonitrile)
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Parameter:
- other: Peptide depletion
- Value:
- 1.44
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Parameter:
- other: C-peptide depletion
- Value:
- -1.46
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Parameter:
- other: K-peptide depletion
- Value:
- 2.88
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The standard calibration curve should have an r² >0.99.
The vehicle control samples should be 0.50 mM +/- 0.05mM.
The CV of the nine vehicle controls should be < 15%.
The variability between these samples should be acceptably low (SD <14.9% for % cysteine depletion and <11.6% for % lysine depletion).
The positive control should cause depletion of both peptides comparable to historic data.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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