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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: according to current guidelines, GLP

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 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(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
Details on test material:
- Name of the test substance used in the study report: (-)-α-Bisabolol

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Animal Breeder: Gaukler, D-6050 Offenbach/Main, FRG
- Mean weight at study initiation: males 3.59 kg, female 3.57 kg
- Housing: Singly housing in stainless steel cages with wire mesh walk floors (floor area: 40 x 51 cm).
- Diet: about 130 g per animal per day of Kliba 341, 4 MM (Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland)
- Water: about 250 mL tap water per animal per 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

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
Single application of 0.1 mL to the conjunctival sac of the right eyelid.
Duration of treatment / exposure:
72 hours (substance not washed out)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (two males, one female)
Details on study design:
The test substance was not washed out.
Readings: 1 h, 24 h, 48 h, 72 h after application
SCORING SYSTEM: acc. to guideline OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 - 72 h
Score:
1.2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Cornea Iris Conjunctiva    
Readings Animal Opacity   Redness Swelling Further findings
1h 1 0 0 2 0  
  2 0 0 2 0  
  3 0 0 2 0  
24h 1 0 0 2 0  
  2 0 0 2 0  
  3 0 0 2 0  
48h 1 0 0 1 0  
  2 0 0 2 0  
  3 0 0 2 0  
72h 1 0 0 0 0  
  2 0 0 0 0  
  3 0 0 0 0  
Mean (24h-72h) 1 0,0 0,0 1,0 0,0  
  2 0,0 0,0 1,3 0,0  
  3 0,0 0,0 1,3 0,0  
Mean (24h-72h) all animals 0,0 0,0 1,2 0,0  

Applicant's summary and conclusion

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