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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
CAS: 078567-28-9
Specific details on test material used for the study:
CAS No.: 078567-28-9; Batch No.: WDJ 1853 D-3; Purity: 100 %; Appearance: yellowish liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
Species / strain / stock / breeder: rabbit / Himalayan / LPT Laboratory of Pharmacology and Toxicology KG branch Lohndorf, D-24601 Lohndorf/Post Wankendorf,
Number of animals examined: 3 male rabbits,
Initial age: approx. 5 - 5.5 months,
Body weight at start of study: 2.4 - 2.6 kg,
Identification: by tattooed number assigned by the Lohndorf breeding station and continuous number 1 - 3,
Duration of study: at least 20 adaptation days,
Administration route: 0.5 ml/patch and animal, once epicutaneous.

Diet: ssniff K-H (ssniff Spezialdiaten GmbH, D-59494 Soest: Composition of the diet) served as food. The food was available ad libitum before and after the exposure period. At regular intervals (at least twice a year) the food is analysed for contaminants by AUA.

Drinking water: Tap water was offered ad libitum before and after the exposure period.
Samples of the drinking water are taken twice a year by the Wasserbeschaffungsverband Harburg, and are analysed according to the Deutsche Trinkwasserverordnung, Bundesgesetzblatt, 1990. In addition, drinking water samples taken at LPT are analysed by LUFA-ITL.

Housing: For 8 hours following test substance application, the animals were kept singly in special restrainers which allowed free movement of the head but prevented a complete body turn and wiping of the eyes.
During the acclimatisation period and after the 8-hour period in restrainers, the rabbits were kept separately in cages with dimensions of 425 mm x 600 mm x 380 mm at a room temperature of 20 °C ± 3 °C (maximum range). Relative humidity was 55 % ± 15 % (maximum range).

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml of the test substance was applied to the test site (area: approx. 6 cm2).
Duration of treatment / exposure:
4 hours
Observation period:
Based on most recent guidelines the skin reactions are monitored until the changes observed have completely subsided, however for not more than 14 days after application. Animals that do not reveal any lesions anymore for 24 hours following the first 72 hours of observation are sacrificed.
Number of animals:
3
Details on study design:
Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used. A dose of 0.5 ml was applied to the test site (area: approx. 6 cm2).
The test substance was applied to the test site and then covered with a gauze patch, which was held in place with non-irritating tape for the duration of the exposure period. The surrounding untreated skin served as a control. Exposure time was four hours. During the exposure the animals were kept in comfortable restrainers.
Examination of the skin: the skin sites were evaluated immediately before the application of the test substance. After the 4 hour exposure period the patch was removed and the skin sites were evaluated. Scores were taken 60 minutes, 24, 48, 72 hours and 4 days after patch removal.
General criteria: body weight of all animals was measured at the beginning of the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was not considered to be irritating to rabbit skin
Executive summary:

A study was conducted to determine a skin irritation potential of the test substance in male Himalayan rabbits according to OECD Guideline 404 and EU Method B.4. 0.5 mL of the test substance was applied to the shaved rabbit skin and then covered with a gauze patch, which was held in place with non-irritating tape for a duration of 4 h. The surrounding untreated skin served as a control. The skin sites were evaluated immediately before the application of the test substance. After the 4 h exposure period the patch was removed and the skin sites were evaluated 60 min, 24, 48, 72 h and 4 d after patch removal. Rabbit number 3 showed an erythema of grade 1 at 48 h after patch removal and animal no. 1 and 2 until 72 h after patch removal. Under the study conditions, the the substance was not considered to be irritating to rabbit skin (Leuschner, 2002).