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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Guideline:
other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
GLP compliance:
no

Test material

1
Reference substance name:
not applicable being a mixture
IUPAC Name:
not applicable being a mixture
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Black powderwater solubility: 40g/lstorage: room temperatureexpiration date: March 2003

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. They were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 +/- 2° C, at a relative humidity of 55 +/- 10 % and on a 10 hours light cycle day. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.

Test system

Type of coverage:
not specified
Preparation of test site:
other: shaved, one side intact and one side abraded
Vehicle:
other: propylene glycol + saline (70 : 30 parts)
Amount / concentration applied:
0.5g of test item, 50% in the vehicle
Duration of treatment / exposure:
24h
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and duringan observation period of 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
results on the abraded skin are also available, and the maximum mean value is 1, fully reversible within 72h. They were not inserted since the Regulation 1272/2008 does not take into account results on scarified skin for the skin irritation evaluation

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Rehulation 1272/2008
Conclusions:
The test item was tested for skin irritation potential. Under the experimental conditions the test item did not show skin irritation properties.
Executive summary:

The test item was tested for skin irritation potential. A group of three males and females NZW rabbits were tested on shaved intact and abraded skin by a 24h exposure to the test item and readings were performed at 24h, 48 and 72h, 4 and 7 days for edema and erythema. Mean values over 24, 48 and 72h were used for assessing he skin irritation potential. Under the experimental conditions the tes item is not considered a skin irritant.