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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, available as unpublished report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Adopted 12 May 1981
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
8-azaspiro[4,5]decane-8-{4-[4''-(2'''-pyrimidinyl)-1''-piperazinyl]-butyne/2/-yl}-7,9-dione /E/-2-butenedionate
EC Number:
947-290-3
Cas Number:
118286-97-8
Molecular formula:
C21H27N5O2 × C4H4O4
IUPAC Name:
8-azaspiro[4,5]decane-8-{4-[4''-(2'''-pyrimidinyl)-1''-piperazinyl]-butyne/2/-yl}-7,9-dione /E/-2-butenedionate
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Buspiron XI. fázistermék
- Physical state: white odourless powder
- Lot/batch No.: 1/1992
- Storage condition of test material: room temperature, protected from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Species: Rabbit
- Strain: New Zealand
- Sex of animals: male
- Number of animals: 3
- Source of animals: Mezőgazdasági Kombinát, Környe 2851
- Weight of study animals determined at the beginning of the study: 3500-3700 g

ENVIRONMENTAL CONDITIONS
- Housing conditions: Animals were kept in cages - 1 animal / cage
- Size of cages: 34 x 37 x 50 cm
- Temperature in the experimental animal room: 20ºC +/- 3ºC
- Relative humidity: 50-70%
- Lighting: artificial - sequence: 12 hours light, 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g test material / animal / area

1. area: control - intact skin, no treatment
2. area: 0.5 g test material, intact skin
3. area: control - abraded skin, no treatment
4. area: 0.5 g test material, abraded skin
Duration of treatment / exposure:
exposure time: 4 hours
Observation period:
Observations were made
- 30 minutes after the treatment
- 1 hour after the treatment
- 4 hours after the treatment
- 24 hours after the treatment
- 48 hours after the treatment
- 72 hours after the treatment
Number of animals:
3 animals were used for the study

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Mortality

 ID of the animal  Day 0 (day of the treatment)  Day 1  Day 2  Day 3
 1133  -  -  -  -
 1134  -  -  -  -
 1135  -  -  -

 -

Clinical signs

 ID of the animal  Day 0  Day 1  Day 2  Day 3
 1133 showed no clinical signs of toxicity showed no clinical signs of toxicity showed no clinical signs of toxicity showed no clinical signs of toxicity
 1134 showed no clinical signs of toxicity showed no clinical signs of toxicity showed no clinical signs of toxicity showed no clinical signs of toxicity
 1135 showed no clinical signs of toxicity showed no clinical signs of toxicity  showed no clinical signs of toxicity showed no clinical signs of toxicity

Body weight

ID of the animal Body weight measured prior to treatment (g)  Body weight measured at the end of the observational period (g)
 1133  3700  3800
 1134  3500  3800
 1135  3600

 3700

Dermal irritation

          Irritation observed after the treatment                                                                
              30 min        1 hour          4 hours           24 hours               48 hours        72 hours   
 ID of animal  area  1  2  3  4  1  2  3  4  1  2  3  4  1  2  3  4  1 2   3  4  1  2  3  4
 1133  Erythema  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0 0   0  0  0  0
   Oedema  0  0  0  0  0  0  0  0 0   0  0 0   0  0  0  0  0 0   0  0  0  0  0  0
 1134   Erythema  0  0  0  0  0  0  0 0   0  0 0  0   0 0   0 0   0  0  0  0  0  0  0  0
     Oedema  0  0  0  0 0   0 0   0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 1135   Erythema  0  0  0  0  0 0   0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0
     Oedema  0  0  0  0  0  0  0 0   0  0  0  0  0  0  0  0  0  0  0  0  0 0   0  0

0: no changes have been observed

areas:

1.area: control - intact skin, no treatment

2. area: 0.5 g test material, intact skin

3. area: control - abraded skin, no treatment

4. area: 0.5 g test material, abraded skin

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material did not cause dermal irritation in the tested dose.