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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:
From 23 september 1992 To 26 September 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Draize test.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: white powder
- Stability under test conditions:
- Storage condition of test material: room temperature under silica gel

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.31-2.82 kg
- Housing: individually in suspended metal cages
- Diet : ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, U.K.)
- Water : ad libitum
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 56-58
- Air changes (per hr): 15
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 23 September 1992 To: 26 September 1992

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE: none
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: dorsal/flank area
- % coverage: no data
- Type of wrap if used: elasticated corset (TUBIGRIP)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material were removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: no data


SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, and 72 hr
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was noted at three treated skin sites one hour after patch removal. all treated skin sites appeared normal 24 hours after treatment.
Other effects:
None

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corosive response data for each male animal after 4h exposure under semiocclusive coverage

score at time point/ Reversibility Erythema
Max. score:4
Edema
Max. score:2
1h 1/0/0/1/0/1 0/0/0/0/0/0
24h 0/0/0/0/0/0 0/0/0/0/0/0
48h 0/0/0/0/0/0 0/0/0/0/0/0
72h 0/0/0/0/0/0 0/0/0/0/0/0
Average 24h, 48h, 72h 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, ITC 288 was non-irritant to rabbit skin. Therefore, no classification is required according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).
Executive summary:

In a primary dermal irritation study (Tuffnell, 1992), six male New Zealand rabbits were dermally exposed to 0.5 g of ITC 288, moistened with 0.5 ml of distilled water for 4 hours under an semi-occlusive dressing. Animals were observed for 3 days. Irritation was scored by the draize scale. A single 4-hour, semi-occluded application of ITC 288 to the intact skin of six rabbits produced very slight erythema. All treated skin sites appeared normal after treatment. Mean scores (24, 48, 72 hours) was 0.0 for erythema and edema. Under the test conditions of this study, ITC 288 is not considered as skin irritant according to the EU legislation (CLP regulation (1272/2008) and Directive 67/548/EEC).

This skin irritation study is classified as acceptable. It satifies the guideline requirement for a skin irritation in the rabbit.