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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: Study conducted according to internationally accepted technical guideline and in compliance with GLP in recognized contract research organization. Despite some minor restrictions, the study report is fully adequate for assessment.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
of 1981
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certified by BAM according to DIN EN 45001.

Test material

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Number: 3 animals,
- Average bodyweight: 3 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: undiluted (no vehicle) after warming the test material to 40°C
Controls:
not required
Amount / concentration applied:
0.5 mL test material (after warming it to 40°C) per approx. 6 cm2 skin (2.5 cm x 2.5 cm) per animal
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 0.5 mL 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:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: erythema or scab formation was not evident
Irritation parameter:
edema score
Remarks:
as defined in Table 1
Basis:
mean
Remarks:
over 3 animals and 3 time points
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: edma formation was not evident
Irritant / corrosive response data:
In each animal, erythema, scab or edema formation was not evident at any observation time point of the study.
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU