Registration Dossier

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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Department of Toxicology, BASF AG

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): beta-Ionone
- Substanz-Nr . : 91/24 5
- Physical state: liquid, yellow
- Analytical purity: 96.9 %
- Lot/batch No.: continous prodution; 8 May 1991
- Storage condition of test material: room temperature, kept under nitrogen
- Stability under test conditions: stable under conditions used in this study, as verified by analysis from April 7th 2003, (GLP)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, Germany
- animal identification: ear tattoo
- Weight at study initiation: males 2.99 and 2.83 kg (mean weight 2.91 kg); female 2.34 kg
- Housing: cage made of stainless steel with wire mesh walk floors; floor area: 40x51 cm; no bedding in cages, saw dust in waste trays
- Diet (e.g. ad libitum): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water (e.g. ad libitum): tap water, about 250 ml/animal/day
- Acclimation period: > 8 days before begin of study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

OTHER: Feed analysis
- diet: the food in this study was assayed for contaminants. In view of the aim and duration of the study the contaminants occuring in commercail feed ought not to influence the results.
- water: drinking water was regulary assayed for contaminants by the municipal authorities of Frankenthal and the technical service of BASF AG. In view of the aim and duration of the study there were no special requirements exceeding the specifications of the drinking water.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untretaed skin site of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 h
Number of animals:
3; 2 male, 1 female
Details on study design:
TEST SITE
- Area of exposure: upper third of back or flank
- Type of wrap if used: test patch (2.5x2.5cm) secured with a porous dressing (four layers of absorbent gauze and porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (polyethylenglykol) and Lutrol:Water (1:1)
- Time after start of exposure: 4 h


SCORING SYSTEM:
Evaluation for erythema (R) and edema (ED):
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe
Calculations of the mean acc. to 83/467/EEC criteria of July 29th, 1983
(for calculation of the means of erythema and edema only the readings of 24, 48 and 72 hours were used) .

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Application of test substance for 4 hrs did not lead to any skin  findings. 
Scores for erythema and edema: 0.0 at all readings (4, 24, 48 and 72  hrs).

Any other information on results incl. tables

Results:

Animal 1: male; 2.99 kg

Animal 2: male, 2.83 kg

Animal 3. female, 2.34 kg

Readings Animal Exposure period: 4 h
Erythema Edema Additional findings
1h 1 0 1  
2 0 0  
3 0 0  
24 h 1 0 0  
2 0 0  
3 0 0  
48 h 1 0 0  
2 0 0  
3 0 0  
72 h 1 0 0  
2 0 0  
3 0 0  
Mean 24 - 72 h 1 0 0  
2 0 0  
3 0 0  
Mean   0 0  
     

Applicant's summary and conclusion

Conclusions:
Semiocclusive application of undiluted beta-Ionone for 4 hrs to rabbit skin did not lead to any signs of irritation.