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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov 14 - Dec 11, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
July 26, 2013
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006. B.40.bis. In vitro skin corrosion: human skin model test
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2’-Phenyl-biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-2-yl)-amine
EC Number:
949-957-4
Molecular formula:
C58H41N
IUPAC Name:
2’-Phenyl-biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-2-yl)-amine
Test material form:
solid

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from a single donor
Justification for test system used:
standard model
Vehicle:
unchanged (no vehicle)
Remarks:
No vehicle used in this study; The test item was applied neat to the tissues.
Details on test system:
CELL CULTURE
- Supplier: EpiSkin/SkinEthic Laboratories, Lyon, France)
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 18-RHE-135
- Expires: Nov 26, 2018

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: room temperature
- Temperature of post-treatment incubation: 37°C

REMOVAL OF THE TEST MATERIAL AND CONTROL
At the end of the exposure periods, the test item, positive and negative control was removed immediately by gently rinsing with a minimum volume of 20 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the tissue inserts and blotting the bottom of the tissue inserts with blotting paper.

Control samples:
yes, concurrent negative control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg ± 2 mg of solid test material
- Concentration (if solution): n/a

VEHICLE
- Amount(s) applied (volume or weight with unit): n/a
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL ± 0.5 µl (deionised water )
- Concentration (if solution): n/a

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL ± 0.5 µl
- Concentration (if solution): A dodecyl sulfate sodium salt solution dissolved deionised water pure was used as positive control.
Duration of treatment / exposure:
42 min
Number of replicates:
3

Test system

Controls:
yes, concurrent negative control
Amount / concentration applied:
16 mg
Duration of treatment / exposure:
42 min

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean relative viability in %
Value:
91.3
Vehicle controls validity:
not applicable
Remarks:
The test item was applied neat to the tissues
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: none
- Colour interference with MTT: none

ACCEPTANCE OF RESULTS:


-Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
The negative control OD values were 1.749, 1.681 and 1.853 and, thus, in the range of ≥0.8 and ≤3.0

-Acceptability of the Positive and Negative Control:
After treatment with the negative control (DPBS-buffer) the mean OD was 1.761 (standard deviation: 4.9%) and, thus, higher than the historically established boundary of 1.424.
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 1.30% (standard deviation: 7.7%) and, thus, lower than the historically established boundary of 2.82%.
The standard deviation of the negative control and the positive control was ≤18%, respectively.


-Test Substance Data Acceptance Criteria:
The standard deviation of the three tissues treated with the test item was 6.7% and, thus, ≤18%.
Therefore, the study fulfilled the validity criteria.




Any other information on results incl. tables

 Group Time / [min]  Mean OD  Mean Relative viability / [%]
 Negative Control 42 1.761 100.00 

 Positive Control

42

0.022

1.30

 Test Material 42 1.608 91.30

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Non-corrosive
Conclusions:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. Under the conditions of the present study, the test item is not considered to be irritant to skin.
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439.Under the conditions of the present study, the test item is not considered to be irritant to skin.