Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
OPINION ON UV filter S86 - Phenylene bis-diphenyltriazine
Author:
Scientific Committee on Consumer Safety - SCCS
Year:
2015
Bibliographic source:
Scientific Committee on Consumer Safety - SCCS, OPINION ON UV filter S86 - Phenylene bis-diphenyltriazine ; 2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
Annex IB.40, Directive 2000/33/CE from the Commission, April 25th 2000.
Principles of method if other than guideline:
To assess the dermal irritation potential of 3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) using Reconstituted Human Epidermis (RHE) made from Human Normal Keratinocytes (SkinethicTM).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Name of the test chemical: 3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine)
Molecular Formula: C36H24N6
Molecular Weight: 540 g/mol
Substance Type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: 3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine)
Molecular Formula: C36H24N6
Molecular Weight: 540 g/mol
Substance Type: Organic
Physical State: Solid
Test substance: WP30
Test batch: LP110
Purity: 99.6% (HPLC, 320 nm)

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from a single donor
Source strain:
other: human
Details on animal used as source of test system:
- Source: 0.5 cm2 Reconstituted Human Epidermis (RHE) made from Human Normal Keratinocytes (SkinethicTM). Abdominal skin from a 48-year-old woman.
- Type: Reconstituted Human Epidermis (RHE) made from Human Normal Keratinocytes (SkinethicTM).
Justification for test system used:
no data available
Vehicle:
other: Paraffin oil
Details on test system:
concentration - 10%
No of replicates: 1
No of applications: 3 repeated applications
Treatment period: 20hours
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
10% in paraffin oil
Duration of treatment / exposure:
3 repeated applications
Duration of post-treatment incubation (if applicable):
no data
Number of replicates:
1

Test animals

Species:
other: not specified
Strain:
not specified
Details on test animals and environmental conditions:
no data available

Test system

Amount / concentration applied:
no data available
Duration of treatment / exposure:
no data available
Observation period:
no data available
Number of animals:
no data available
Details on study design:
no data available

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
single run
Value:
100
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) does not reduce MTT in a specific way. At the concentration of 10%, the cell viability was 100%.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) does not reduce MTT in a specific way. At the concentration of 10%, the cell viability was 100%. Hence, 3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) was considered not a skin irritant.
Executive summary:

The dermal irritation potential of 3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) was assessed using Reconstituted Human Epidermis (RHE) made from Human Normal Keratinocytes (SkinethicTM). The test was performed according to the Guidelines mentioned inAnnex IB.40, Directive 2000/33/CE from the Commission, April 25th 2000.

3 repeated applications of10% test chemical in paraffin was done to the0.5 cm2 Reconstituted Human Epidermis (RHE) made from Human Normal Keratinocytes (SkinethicTM). Abdominal skin from a 48-year-old woman was used. The treatment was continued for 20 hours.5% SDS in water and Crème reparatrice cicalfate, Avéne Laboratory, batch F2268, pure were used as positive and negative controls respectively. The MTT method was used forin vitrocytotoxicity testing. An MTT direct-interaction test was made before the main test on reconstructed epidermis.

The test chemical did not interact with MTT.

3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) does not reduce MTT in a specific way. At the concentration of 10%, the cell viability was 100%. Hence,3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) was considerednot a skin irritant.