Registration Dossier
Registration Dossier
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EC number: 810-797-4 | CAS number: 331711-99-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
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
- Physical state: solid
- Analytical purity: approx. 98.153%
- Test substance No.: 13/0254-1
- Batch No.: LJ-008-09-136
- pH: ca. 5 (undiluted test material, moistened with water)
Constituent 1
Test animals
- Species:
- other: not applicable (in vitro test)
- Strain:
- other: not applicable (in vitro test)
Test system
- Type of coverage:
- other: not applicable (in vitro test)
- Preparation of test site:
- other: not applicable (in vitro test)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable (in vitro test)
- Amount / concentration applied:
- see "Any other information on materials and methods incl. tables"
- Duration of treatment / exposure:
- see "Any other information on materials and methods incl. tables"
- Observation period:
- see "Any other information on materials and methods incl. tables"
- Number of animals:
- not applicable (in vitro test)
- Details on study design:
- TEST SYSTEM:
Three dimensional human epidermis model
The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: mean tissue viability (%)
- Value:
- 111
- Remarks on result:
- other:
- Remarks:
- Basis: other: Thane 003-6. Remarks: no potential for skin irritation. (migrated information)
- Irritation / corrosion parameter:
- other: other: mean tissue viability (%)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: negative control. Remarks: no potential for skin irritation. (migrated information)
- Irritation / corrosion parameter:
- other: other: mean tissue viability
- Value:
- 3
- Remarks on result:
- other:
- Remarks:
- Basis: other: positive control: 5% SDS. Remarks: skin irritation potential. (migrated information)
In vivo
- Irritant / corrosive response data:
- The substance is not able to reduce MTT directly. The mean viability of the test substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 111%.
Any other information on results incl. tables
Results from EpiDerm(TM) Skin irritation test:
Test substance |
|
Tissue 1 |
Tissue 2 |
Tissue 3 |
Mean |
SD |
NC |
mean OD570 |
2.340 |
2.311 |
2.223 |
2.291 |
|
viability (% of NC) |
102.1 |
100.9 |
97.0 |
100 |
2.66 |
|
Thane 003 -6 |
mean OD570 |
2.500 |
2.476 |
2.622 |
2.533 |
|
viability (% of NC) |
109.1 |
108.1 |
114.5 |
111 |
3.42 |
|
PC |
mean OD570 |
0.075 |
0.066 |
0.0836 |
0.075 |
|
viability (% of NC) |
3.3 |
2.9 |
3.6 |
3 |
0.37 |
NC, negative control; PC, positive 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.
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