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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
Remarks:
Test substance represents a main component (stereoisomer) of the registered substance
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(Paris, 1981)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Levomenol
EC Number:
245-423-3
EC Name:
Levomenol
Cas Number:
23089-26-1
Molecular formula:
C15H26O
IUPAC Name:
(2S)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol
Test material form:
other: Liquid
Details on test material:
(-)-α-Bisabolol

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Animal Breeder: gaukler; D-6050 Offenfach/ Main, FRG
- Weight at study initiation: male 2.84 kg, females 3.0 kg
- Housing: Singly housing in stainless steel cages with wire mesh walk floors (floor area: 40 x 51 cm).
- Diet: Kilba 341, 4 MM (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: at least 8 days before study start (same housing conditions as during the study).

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod: 12 h /12 h (6.00 - 18.00 hours / 18.00 - 6.00 hours)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
no vehicle
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
Application of 0.5 mL of the undiluted test substance to test patches (2.5 x 2.5 cm).
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
Clipping of the fur: at least 15 hours before study start
Test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage)
Application site: upper third of the back or flanks
Removal of the test substance at the end of the exposure period with Lutrol and Lutrol/water (1:1).
Readings: 30 - 60 minutes after removal of the test patch and 24 h, 48 h, 72 h and 7 d after beginning of application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48h, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: only one animal showed a slight edema after 24 h

Any other information on results incl. tables

Readings Animal Erythema Edema Further findings
4h 1 1 0  
  2 1 0  
  3 1 0  
24h 1 2 0  
  2 1 0  
  3 2 1  
48h 1 1 0  
  2 0 0  
  3 2 0  
72h 1 0 0 scaling
  2 0 0  
  3 1 0 scaling
7d 1 0 0 scaling
  2 0 0 scaling
  3 0 0 scaling
Mean (24h-72h) 1 1,0 0,0  
  2 0,3 0,0  
  3 1,7 0,3  
Mean (24h-72h) all animals 1,0 0,1  

Applicant's summary and conclusion

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