Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Principles of method if other than guideline:
Each of 3 animals had 0.1 ml of test sample instilled into the right eye. The untreated left eye served as the control. Both the treated and control eyes were examined every 24 hours for 4 days and then again on the 7th day. Scorings were made according to the Draize scale for scoring ocular lesions.
GLP compliance:
no
Remarks:
Study predates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Lemonile
- Substance type: Clear colourless liquid
- Physical state: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
other: Propylene glycol
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.1 mL
- Concentration: 0.5 % in propylene glycol.
Duration of treatment / exposure:
Test material applied once.
Observation period (in vivo):
7 days (observations at 24 hrs, 48 hrs, 72 hrs, 96 hrs and 7 d).
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: None

SCORING SYSTEM:
- Draize scale for scoring ocular lesions.
- Cornea, iris and conjunctiva examined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
No animals showed any reaction to the test substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Lemonile was not irritating to the eyes.