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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:
key study
Study period:
September 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Javanol
- Physical state: Pale yellow viscous liquid
- Analytical purity: 88.4% (GC, sum of two peaks)
- Lot/batch No.: 008825
Specific details on test material used for the study:
Name of test material (as cited in study report): Javanol
- Physical state: Pale yellow viscous liquid
- Analytical purity: 88.4% (GC, sum of two peaks)
- Lot/batch No.: 008825

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
1 male and 2 females
Age at start of treatment: 15 weeks
Acclimatization: four days under test conditions after health examination. Only animals without any visual signs of illness were used for the study.
Standard laboratory conditions: 10-15 air changes per hour, temeprature target at 22 +/- 3°C and relative humidity between 40-70% (values above 70% during cleaning process possible). 12 hour dark/light cycle. Recorded music was played for approximately 8 hours during the light period.
Accomodation: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls and wood for gnawing.
Diet: Pelleted standard Kliba 341 rabbit maintenance diet ad libitum (batch no. 77/97).
Diet source: 'Kliba', Kliba Mulhen AG, Switzerland
Water: Community tap water for Itingen, ad libitum, in water bowls.

Test system

Amount / concentration applied:
0.1 ml per animal of Javanol was applied undiluted as it was delivered by the sponsor, at the conjuctival sac of left eye of each animal. The right eye remained untreated and served as te reference control.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 22
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 23
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 24
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 22
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 23
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 24
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 22
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 23
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 24
Time point:
24/48/72 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 22
Time point:
24/48/72 h
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal: 23
Time point:
24/48/72 h
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal: 24
Time point:
24/48/72 h
Score:
0.67
Irritant / corrosive response data:
Irritation: Application of the test article to healthy rabbit conjunctivae resulted in a primary eye irritation score of 0.78. Slight to moderate reddening and sweling of the conjunctivae were noted in all animals after one hour. Slight to moderate reddening of the conjunctivae persisted in all animals after 24 hours and in one animal after 48 hours. Moderate watery discharge was evident in all animals, as was hyperemia of the scleral blood vessels. All findings were reversible after 72 hours.
Corrosion: No corrosion of the cornea was observed at any of the reading times.
Other effects:
Coloration: No staining of the cornea, sclera or conjunctivae by the test article was observed.
Body weights: The body weight of all rabbits were considered to be within the normal range of viariability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the referred classification criteria, Javanol is considered to be 'not irritating' to the rabbit eye.
Executive summary:

The primary eye irritation potential of the test article was investigated by instillation of 0.1 ml into one eye of each of three young adult New Zealand White rabbits. The treated eyes were not ronsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then divding the resulting total by the number of data points. The primary irritation score was 0.78 (max. 13).

Reddening and/or swelling the conjunctivae were noted in all animals after 24 hours. Reddening was noted after 48 hours in one animal only. Watery discharge and hyperemia of the sclera blood vessels were seen in all animals after one hour. All findings were reversible after 72 hours.

No staining of the sclera, conjunctivae and cornea of the treated eyes by the test article was observed.

No corrosion was observed at any measuring intervals.

Based upon the referred classification criteria (EEC Comission Directive 93/21/EEC of April 27, 1993), Javanol is considered to be 'not irritating' to the eye.