1,1'-(4-chlorobutylidene)bis[4-fluorobenzene]

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine)

Cas Number:

55514-22-2

Molecular formula:

C36H24N6

IUPAC Name:

3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine)

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 or test system 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.