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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-07-09 - 1992-08-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol
EC Number:
411-380-6
EC Name:
2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol
Cas Number:
147315-50-2
Molecular formula:
C27 H27 N3 O2
IUPAC Name:
2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach/Riss, Germany
- Weight at study initiation: 2320 - 2430 g
- Housing: Individually in metal cages
- Diet: Standard diet, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: At least 5 days

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

IN-LIFE DATES: From: 1992-07-21 To: 1992-07-24

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: patches moistened with distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g/animal
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3 (female rabbits)
Details on study design:
TEST SITE
An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test item was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape, followed by removal of the gauze patches.

SCORING SYSTEM:
The skin reaction was assessed according to the OECD scoring system at 1, 24, 48 and 72 hours intervals (after the removal of the gauze patches).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4

Any other information on results incl. tables

The body weight gain of all rabbits was similar. No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a primary dermal irritation study three New Zealand White rabbits were dermally exposed to 0.5 g test item (as described in section 1.2). Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 3 days and the irritation was scored at 1, 24, 48, and 72 hour(s). In this study, no signs of dermal irritation were observed. Thus, the test item was not irritating to the rabbit skin under the conditions of this study.