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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
of 1981
Deviations:
no
Qualifier:
according to
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Remarks:
Certified by BAM according to DIN EN 45001.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: The test material contained 50% WS400517 in organic solvent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Number: 3 animals,
- Average bodyweight: 3.0 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS

Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: The test material contained 50% WS400517 in organic solvent and was used after warming to 40°C
Controls:
not required
Amount / concentration applied:
500 mg test material (i.e. formulation containing 50.3% WS400517) per approx. 6 cm2 skin (2.5 cm x 2.5 cm) per animal.
The test material was warmed to 40°C for administration.
Duration of treatment / exposure:
4 hours
Observation period:
7 days post patch removal
Number of animals:
3
Details on study design:
TEST SITE PREPARATION

Samples of 500 mg of the warmed test substance were applied to the shaved skin of albino rabbits and covered with gauze squares of the size 2.5 cm x 2.5 cm on the skin. Patches were fixed with adhesive plaster. Untreated shaved skin served as controls.

TREATMENT PERIOD AND REMOVAL OF TEST SUBSTANCE

Semi-occlusive treatment lasted 4 hours. Then the dressings were removed and residual test substance was dabbed off the skin with a wet towel.

Time points of skin evaluation:

The treated skin patches were evaluated at 1 hour post patch removal and at 24, 48 and 72 h and 7 days post patch removal. Only differences from controls were considered to be positive reactions. The scoring system for the grading of skin reactions is listed in Table 1 (next field below).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
as defined in Table 1
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h (erythema grade 1 was seen in 3 animals at 1 hour post patch removal)
Irritation parameter:
edema score
Remarks:
as defined in Table 1
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h (edema grade 1 was seen in 1 animal at 1 hour post patch removal)
Irritant / corrosive response data:
At 1 hour post patch removal, erythema grade 1 (slight in degree and scarcely visible) was recorded in each animal and was associated with an edema grade 1 (very slight in degree and scarcely visible) in one of them. By 24 hours post patch removal and during the remainder of the 7-day observation period signs of irritation were no longer evident.
Other effects:
Mortality or behavioural changes indicative of an adverse effect were not evident. Weighing of the animals at 7 days post treatment revealed normal body weight gain.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met