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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
BIOPESTICIDES REGISTRATION ACTION DOCUMENT - l-Carvone
Author:
U.S. Environmental Protection Agency - Office of Pesticide Programs; Biopesticides and Pollution Prevention Division
Year:
2009
Bibliographic source:
BIOPESTICIDES REGISTRATION ACTION DOCUMENT - l-Carvone, U.S. Environmental Protection Agency, last updated 2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the ocular irritation potential of l-carvone in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of the test material: L-p-mentha-1(6),8-dien-2-one Common Name: l-CarvoneMolecular Formula: C10H14OMolecular Weight: 150.2196 g/molSmiles:C1[C@@H](CC=C(C1=O)C)C(C)=CInChI: 1S/C10H14O/c1-7(2)9-5-4-8(3)10(11)6-9/h4,9H,1,5-6H2,2-3H3/t9-/m1/s1Substance Type: OrganicPhysical State: Liquid
Specific details on test material used for the study:
Name of the test material: L-p-mentha-1(6),8-dien-2-one Common Name: l-CarvoneMolecular Formula: C10H14OMolecular Weight: 150.2196 g/molSubstance Type: OrganicPhysical State: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
other: Tween 80
Controls:
not specified
Amount / concentration applied:
10% test material in Tween 80
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24 hours
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
no data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
fully reversible within: 24 hours
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Slight transient conjunctivitis with unaffected corneas was observed which resolved within 24 hours

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Slight transient conjunctivitis with unaffected corneas was observed which resolved within 24 hours. Hence, l-carvone can be considered to be not irritating to eyes after 24 hours of exposure.
Executive summary:

An eye irritation study was performed in rabbits to assess the irritation potential of l-carvone.

10% l-carvone in Tween 80 was instilled into the eyes of 3 New Zealand white rabbits and observed for signs of irritation till 24 hours.Slight transient conjunctivitis with unaffected corneas was observed which resolved within 24 hours.

 Hence, l-carvone can be considered to be not irritating to eyes after 24 hours of exposure.