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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:
from 27th May 1997 to 3rd lune 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: B & K UNIVERSAL G.J., S.L. (Sant Vincenç; dels Horts, Barcelona, Spain) on 12th May 1997 (no. 954, 958 and 972)
- Age at study initiation: 9-11 weeks.
- Weight at study initiation: 2.0-2.4 kg
- Housing: housed individually in stainless steel cages (48 x 59 x 37 cm), with a grille floor, placed on racks.
- Diet: The animals were allowed free access to a standard rabbit diet UAR 112
- Water: water was supplied ad libitum by an automatic drinking system.
- Acclimation period: 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 40 - 75 %
- Photoperiod: 12 hours cycle dark/light (7:00 to 19:00)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
at 1, 24, 48, 72 hours and 7th day
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: 6.2 cm^2
- % coverage: 2.5 x 2.5 cm^2
- Type of wrap if used: surgical gauze. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal in order to hold the patches in place. The gauze was fixed to the body using additional adhesive tape.

EVALUATION
The observations carried out were assessed according to the numerical scale and the degree of enythema and the formation of eschars and edema were quantified, as outlined in the OECD GUIDELINE FOR TESTING OF CHEMICALS, No. 404, of 17th July 1992.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Other effects:
Clinical signs:
The behaviour and physical condition of the rabbits were normal throughout the Study.

Any other information on results incl. tables

Very slight, practically not noticeable, erythema (grade 1) was observed in all the animals as well as a yellow staining of the administered areas. Similarly, one ofthe animals was observed to present very slight edema (grade 1).

In the readings carried out at 24 -48 hours after removing the patches two of the animals continued to show very slight eiythema (grade 1) while the yellow staining of the administered areas was still observed in all the animals. At 72 hours, this presence of the yellow staining was still noted and only one animal continued to show very slight eiythema (grade 1). In the additional reading carried out 7 days post-treatment, the erythema had disappeared while the yellow staining remained in one ofthe animals.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) no. 1272/2008
Conclusions:
The test item resulted not be irritating to the rabbit skin.
Executive summary:

The degree of skin irritation caused by the substance was determined after its application to shaved rabbit skin, according to the OECD Guideline No. 404 (1992) and the method B.4 of the EEC Guidelines of 31st July 1992 (92/69/EEC). The substance was applied using a semi-occlusive patch, left for 4 hours.

The mean values (24/48/72 h) for edema scores were 0 in all animals; for erythema scores were 0.67, 1 and 0 in animals #1, #2 and #3 respectively. All the effects observed were fully reversible within the 7day-study period.