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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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Standard guideline study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH 88353 Kißlegg
- Weight at study initiation: 2.0-2.2 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: sesame oil
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 50 % suspension

VEHICLE
- Amount(s) applied (volume or weight with unit): 500µL
Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: cellulose patch on a piece of surgical plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water after exposure
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4-72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
a transient, very slight erythema was recorded at the end of exposure only
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 this study test item is not irritating to skin.
Executive summary:

PROCEDURE

About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm². Only animals with intact skin were used.

Each animal was treated with 0.5 g of the test item pasted with 0.5 ml sesame oil DAB 10.

The substance was administered over the whole surface of a 2.5 x 2.5 em cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage .

The exposure period was 4 hours.

After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE

All other changes of the skin were recorded.

RESULTS

30 - 60 minutes after decontamination two animals showed very slight erythema. 24 hours after decontamination all signs of irritation disappeared.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated: Erythema and eschar all animals: 0.0

Oedema formation all animals: 0.0

Conclusion

Based on the results of this study the test item is not irritating to skin.