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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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to GLP and meets OECD and EEC guideline requirements.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): T-4388
- Lot/batch No.: Lot 6
- Physical state: Colorless liquid
- Storage condition of test material: Test material was stored in the dark under ambient conditions

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited, Duddon Lodge, Tarporley, Cheshire
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays
- Diet (e.g. ad libitum): The rabbits were fed Standard Rabbit Diet, supplied by Special Diets Services, 1 Stepfield, Witham Essex, CMB 3AD.
- Water (e.g. ad libitum): Tap water was allowed ad libitum
- Acclimation period: 7 days
- IN-LIFE DATES: From: 28 March 1990 To: 31 March 1990

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean environmental maximum and minimum temperatures were 17º C and 16 º C.
- Humidity (%): Mean relative humidity was 68%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle (light hours 0700-1900 h)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml



Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 h after patch removal
Number of animals:
3 (2 male and one female)
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: The test material (0.5 ml) was applied to intact skin on each rabbit under a 2.5 cm × 2.5 cm patch of gauze.
- Type of wrap if used: The patch was covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of exposure period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material
- Time after start of exposure: 4 h


SCORING SYSTEM: See the attachment- Scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin reactions were noted following a 4 h semi-occlusive application of T-4388 to rabbit skin.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study it was concluded that T-4388 was non-irritant to rabbit skin.
Executive summary:

The acute dermal irritation potential of a test material, T-4388, a colorless liquid was investigated in New Zealand White rabbits. Two male and one female nulliparous and non-pregnant young adult rabbits were used.

The rabbits were housed individually in aluminium cages and were fed with standard rabbit diet and tap water was allowed ad libitum. Mean environmental maximum and minimum temperatures were 17º C and 16 º C and mean relative humidity was 68%. A 12 h light/dark cycle was in operation. The rabbits were allowed an acclimatisation period of 7 days before test commencement.

The rabbits were uniquely identified within the study by means of an indelible number on the inner surface of the ear. The hair was clipped from the dorsal area of the trunk of each rabbit under a 2.5 cm × 2.5 cm patch of gauze. The patch was then covered with micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage which remained in position for 4 h. At the end of this period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material.

Skin reactions were assessed 1, 24, 48 and 72 h after patch removal using the OECD recommended scoring system. No skin reactions were noted following a 4 h semi-occlusive application of T-4388 to rabbit skin.

Based on the results of the study it was concluded that T-4388 was non-irritant to rabbit skin.

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