Registration Dossier

Diss Factsheets

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:
2014
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

Constituent 1
Chemical structure
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)

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