Registration Dossier

Diss Factsheets

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

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no findings
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