4,6-diphenyl-1,3,5-triazin-2(1H)-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

, compared to the recent version of OECD TG 404 (2002), testing was performed under occlusive conditions instead of semi-occlusive conditions.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Hydroxy-4,6-diphenyl-l, 3,5-triazin

IUPAC Name:

2-Hydroxy-4,6-diphenyl-l, 3,5-triazin

Details on test material:

- Name of test material (as cited in study report): FAT 92376/A
- Physical state: solid, white crystals
- Analytical purity: 98%
- Lot/batch No.: 10.26
- Storage condition of test material: room temperature
- Other:
Test material received: 11 Feb 1993

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: New Zealand White (Chbb:NZW) rabbits from Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: no data
- Weight at study initiation: 2610 - 2770 g
- Housing: single housing in metal cages
- Diet (e.g. ad libitum): Standard rabbit pellet (Nafag No 814), Gossau, Switzerland
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70
- Photoperiod:12 hrs dark / 12 hrs light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: The test material was moistened with the vehicle.

Duration of treatment / exposure:

4 h

Observation period:

72 h (observation period was shortened because of the lack of skin reactions 24, 48, and 72 after patch removal)

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze patch (12-16 cm2)
The patches were loosely covered with an aluminium foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

SCORING SYSTEM: Draize scheme

Observation of systemic symptoms and mortality: once daily
Evaluation of skin reactions: 1, 24, 48, and 72 hours after removing of gauze patches.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no findings

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: no findings

Irritant / corrosive response data:

No findings were observed at the side of the test patches in any of the animals. After 1 h an erythema score of 1 was observed in 2/3 animals. These findings were fully reversible within 24 h. No scores higher than 0 for erythema and edema were observed in any animal at the time points 24, 48, and 72 h.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information