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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:
other: Guideline study conducted in accordance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Citronellyl acetate
EC Number:
205-775-0
EC Name:
Citronellyl acetate
Cas Number:
150-84-5
Molecular formula:
C12H22O2
IUPAC Name:
3,7-dimethyloct-6-en-1-yl acetate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Citronellyl acetate
- Substance number: 94/369
- Physical state: liquid
- Appearance: achromatic
- Analytical purity: 98.8%
- Lot/batch No.: 4 + 5, ABL. NR. 08-0194
- Stability under test conditions: stable over testing period (acc. to reanalysis)
- Storage condition of test material: refrigerator, exclusion of light, tightly closed
- Other: Manufactory date: 24-05-1994

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR. K. Thomae GmbH, Biberach
- Age at study initiation: young adult
- Animal identification: ear tattoo
- Weight at study initiation: female: 3.76 kg; male: 3.41 and 3.48 kg
- Housing: single housing, stainless stell wire mesh cages with grating, floor area: 3000 cm2
- Bedding: no bedding in the cages; sawdust in the waste trays
- Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g/animal/day)
- Water: Tap Water (about 250 ml/animal/day)
- Acclimation period: at least 1 week

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: negative control: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml on intact untreated skin
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
3
Details on study design:
TEST SITE
- Preparation: at least 24 h before the test, the fur was removed by clipping the dorsal of the trunk of the animal; only animals with healthy/intact skin were used
- Area of exposure: upper third of back or flanks
- Application: 2.5 x 2.5 cm test patch moistened with 0.5 ml of the test substance
- Type of wrap if used: test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adheasive Fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol (BASF SE) and Lutrol in water (1:1)
- Time after start of exposure: 4 h

READING
- 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after patch removal

OBSERVATIONS
- Check for general observations and dead or moribund animals: twice daily (Mo - Fr), once daily (Sa/Su)
SCORING SYSTEM
- According to OECD guideline 404 (adopted july 17, 1992) and EEC L 383A, B.4 (december 29, 1992)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals tested
Time point:
other: 24, 48, 72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals tested
Time point:
other: 24, 48, 72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

For calculation of the means only the 24, 48 and 72 hours readings were taken into consideration.

Irritant response data:

Readings Animal Exposure period: 4 h
Erythema Edema Additional findings
1h 1 2 1  
2 2 1  
3 2 1  
24 h 1 3 2  
2 3 1  
3 3 1  
48 h 1 3 1  
2 2 1  
3 2 1  
72 h 1 3 0  
2 2 0  
3 2 0  
8 d 1 1 0 scaling
2 0 0 scaling
3 0 0 scaling
15 d 1 0 0 scaling
2 0 0  
3 0 0  
Mean 24 - 72 h 1 3 1  
2 2.3 0.7  
3 2.3 0.7  
Mean   2.5 0.8  

Animal 1: female; animal 2: male; animal 3: male

Applicant's summary and conclusion