Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: Guideline study conducted in accordance with GLP. The observation period was restricted to 72 hours since no dermal effects were seen at all in the 3 treated animals.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TKA 40135 (CGI 819)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Regal Group UK, Great Bookham, Surrey, England.
- Age at study initiation: 12 to 15 weeks
- Weight at study initiation: 3 to 3.6 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): ca. 19
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately100 mm X 100 mm.
Controls:
other: the untreated skin area served for control
Amount / concentration applied:
A 0.5 g amount of the test substance was applied under a 25 mm x 25 mm gauze pad which had been moistened with 0.5 mL distilled water to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. Aluminium foil was incorporated into the dressing to reduce photoinduced disintegration of the test material.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three animals were used
Details on study design:
REMOVAL OF DRESSING
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with lukewarm water to remove any residual test substance. The treated area was blotted dry with absorbent paper.

EXAMINATIONS
Examination of the treated skin was made on the first day after one hour following removal of the dressing, and on day 2, 3 and 4 (equivalent to 24, 48 and 72 hours) post-exposure.
Moreover, the animals were observed daily for signs of ill health or toxicity.

SCORING SYSTEM
Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation:
- No erythema 0
- Very slight erythema (barely perceptible) 1
- Well-defined erythema 2
- Moderate to severe erythema 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth) preventing erythema reading 4
Edema formation:
- No edema 0
- Very slight edema (barely perceptible) 1
- Slight edema (edges of area well-defined by definite raising) 2
- Moderate edema (raised approximately 1 millimetre) 3
- Severe edema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no signs of erythema were seen after 1 h, 24 h, 48 h and 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 -48 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no signs of erythema were seen after 1 h, 24 h, 48 h and 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no signs of erythema were seen after 1 h, 24 h, 48 h and 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema was seen after 1 h, 24 h, 48 h and 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema was seen after 1 h, 24 h, 48 h and 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: no edema was seen after 1 h, 24 h, 48 h and 72 h
Irritant / corrosive response data:
No dermal response to treatment was observed in any animal throughout the observation period.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion