Registration Dossier
Registration Dossier
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EC number: 228-391-5 | CAS number: 6258-06-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according to GLP according to a standardized and validated produre.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Peptide reactivity determined by incubation with two model peptides and HPLC-analysis of peptide concentration.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Peptide-binding assay (DPRA)
Test material
- Reference substance name:
- Sodium 1-amino-4-bromo-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 228-391-5
- EC Name:
- Sodium 1-amino-4-bromo-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 6258-06-6
- Molecular formula:
- C14H8BrNO5S.Na
- IUPAC Name:
- sodium 1-amino-4-bromo-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Details on test material:
- - Name of test material (as cited in study report): Bromaminic acid sodium salt
- Substance type: no data
- Physical state: no data
- Analytical purity: given as 100% , analytical characterization ongoing
- Purity test date: 2012
- Lot/batch No.: 0005790051
- Expiration date of the lot/batch: 14 Dec 2013
- Stability under test conditions: stable (indicated by sponsor)
- Storage condition of test material: no data
-Other: The test substance was homogeneous by visual inspection.
Constituent 1
In vivo test system
Test animals
- Species:
- other: not applicable
- Strain:
- other: not applicable
Study design: in vivo (non-LLNA)
- Positive control substance(s):
- yes
- Remarks:
- Ethylene glycol dimethacrylate
Results and discussion
- Positive control results:
- Ethylene glycol dimethacrylate was used as positive control. It caused a mean peptide depletion of 24%.
Any other information on results incl. tables
The mean K-peptide depletion, caused by the test substance was determined to be 99.0%.
The mean C-peptide depletion, caused by the test substance was determined to be 10.1% in the first test run and 5.8% in the second evaluable test run. Hence, the mean C-peptide depletion was detrmined to be 8.0%.
Thus, the mean peptide depletion was calculated to be 53.5%.
No co-elution of test substance and peptides was noticed.
Based on the observed results and applying the prediction model proposed in Gerberick et. al (2007) it was concluded that Bromaminic acid sodium salt shows a high protein binding reactivity in the DPRA under the test conditions chosen.
Applicant's summary and conclusion
- Interpretation of results:
- other: The substance binds to peptides in vitro.
- Executive summary:
Depletion of the Cystein-Peptide was 5,8%; depletion of the Lysin-Peptide was 99%. Therefore, the substance shows strong peptide-binding reactivity.
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