Registration Dossier
Registration Dossier
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EC number: 810-797-4 | CAS number: 331711-99-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- other: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented GLP study, in-house validated procedure
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 442C (adopted 4 February 2015): In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- other: direct peptide reactivity assay
Test material
- Reference substance name:
- 8-(benzoyloxy)naphthalen-1-yl benzoate
- EC Number:
- 810-797-4
- Cas Number:
- 331711-99-0
- Molecular formula:
- C24 H16 O4
- IUPAC Name:
- 8-(benzoyloxy)naphthalen-1-yl benzoate
- Details on test material:
- - Name of test material (as cited in study report): Thane 003-6
- Analytical purity: approx. 98.153%
- Test substance No.: 13/0254-1
- Lot/batch No.: LJ-008-09-136
Constituent 1
In vivo test system
Test animals
- Species:
- other: synthetic peptides (Cysteine- (C-) containing peptide: Ac-RFAACAA-COOH; Lysine- (K-) containing peptide: Ac-RFAAKAA-COOH)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: peptide depletion (K-peptide)
- Group:
- test chemical
- Dose level:
- 0.23
- Remarks on result:
- other: Reading: other: peptide depletion (K-peptide). Group: test group. Dose level: 0.23.
- Reading:
- other: peptide depletion (K-peptide)
- Group:
- negative control
- Dose level:
- 0
- Remarks on result:
- other: Reading: other: peptide depletion (K-peptide). Group: negative control. Dose level: 0.
- Reading:
- other: peptide depletion (K-peptide)
- Group:
- positive control
- Dose level:
- 16.89
- Remarks on result:
- other: Reading: other: peptide depletion (K-peptide). Group: positive control. Dose level: 16.89.
- Reading:
- other: peptide depletion (C-peptide)
- Group:
- test chemical
- Dose level:
- 16.01
- Remarks on result:
- other: Reading: other: peptide depletion (C-peptide). Group: test group. Dose level: 16.01.
- Reading:
- other: peptide depletion (C-peptide)
- Group:
- negative control
- Dose level:
- 0
- Remarks on result:
- other: Reading: other: peptide depletion (C-peptide). Group: negative control. Dose level: 0.
- Reading:
- other: peptide depletion (C-peptide)
- Group:
- positive control
- Dose level:
- 69.69
- Remarks on result:
- other: Reading: other: peptide depletion (C-peptide). Group: positive control. Dose level: 69.69.
Any other information on results incl. tables
|
Cysteine-Peptide |
Lysine-Peptide |
Mean of both depletions (%) |
||
Mean depletion (%) |
SD |
Mean depletion (%) |
SD |
||
Thane 003-6 |
16.01 |
4.43 |
0.23 |
0.55 |
8.12 |
PC: EGDMA in AC |
69.69 |
9.83 |
16.89 |
0.85 |
43.29 |
PC: EGDMA in ACN |
54.66 |
3.77 |
12.86 |
1.14 |
33.76 |
AC, acetone; ACN, acetonitrile; PC, postitive control
Applicant's summary and conclusion
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