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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
