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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Remarks:

But audited by Quality Assurance

Test material

Test material information

Constituent 1

Reference substance name:

3-[4-(5,6-diphenyl-1,2,4-triazin-3-yl)phenyl]-5,6-diphenyl-1,2,4-triazine

EC Number:

700-823-1

Cas Number:

55514-22-2

Molecular formula:

C36H24N6

IUPAC Name:

3-[4-(5,6-diphenyl-1,2,4-triazin-3-yl)phenyl]-5,6-diphenyl-1,2,4-triazine

Details on test material:

- Name of test material (as cited in study report): CH022 WP30
- Physical state: powder
- Analytical purity: 99.8 %
- Purity test date: January 7th, 2012
- Lot/batch No.: LP140
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in a dark and well ventilated place

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Weight at study initiation: males: approximately 250 g, females: approximately 200 g
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2
- Humidity (%): between 40 and 70
- Air changes (per hr): > 10 full air changes
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): direct application of 2000 mg/kg bw

Duration of treatment / exposure:

24 +/- 1 hours

Observation period:

14 days

Number of animals:

5 males and 5 females

Details on study design:

TEST SITE
- Area of exposure: 6 x 5 cm
- % coverage: 10 %
- Type of wrap if used: Gauze patch held in close contact with the skin by means of a non occlusive tape Micropore

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the testsite was wiped with a cotton pad soaked with purified water
- Time after start of exposure: 24 +/- 1 hours

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

0

Basis:

mean

Time point:

other: 15 days

Score:

0

Irritant / corrosive response data:

None

Other effects:

Desquamation on D5 in one female and on D8 in 2 females

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Neither erythema nr edema was observed in any animal tested so the individual irritation index was 0 for all animals. Consequently the Primary Irritation Index of the group was also 0.

Executive summary:

The objective of this study was to evaluate the potential toxicity of the test item CH0222 WP30 after a single topical application for a 24-hour exposure period on Wistar rat skin.

5 male and 5 female Wistar rats (RjHan: WI, SPF albino rats from Janvier) were treated at 2000 mg/kg corresponding to the limit test.

On the day of application (Dl), a weight based quantity of test item was moistened with purified water and applied directly onto the dorsal part of the trunk of each animal which had been clipped the day before. The test item was evenly spread over the application site which represented at least lO% of the body surface. The application site was then covered with a gauze patch held in close contact with the skin by means of a non occlusive tape for a 24h exposure period. At the end of the exposure period, the patch was removed and the test site was wiped with a cotton pad soaked with purified water.

Animals were observed at least once daily for mortality and general clinical signs for 15 days and were weighed on Dl, D3, D8 and D15.

Skin reactions were evaluated for all animals approximately 1 hour (D2), 24h (D3), 48h (D4) and 72h (DS) after patch removal at the end of the contact period and on D8 and Dll. The responses, erythema and edema, were scored according to a table graded from 0 (no skin reaction) up to 4 (severe reaction).

Neither erythema nor edema was observed so that the Individual Irritation Index was equal to o for all animals. Consequently, the Primary Irritation Index of the group was also equal to O. Desquamation was present on DS in one female and on D8 in 2 females.

CH0222 WP30 was non irritating to skin.