Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 21, 1992 - September 24, 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD 405 (1987) and EU Method B.5 (1984) and according to GLP principles. Limited information available to verify the composition of the used test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(1984)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KY-ET
- Appearance: Light yellow solid
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 14 weeks
- Weight at study initiation: 2487 - 2704 grams
- Housing: Individually housed in cages with perforated floors.
- Diet: Free access to standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g/day
- Water: Free access to tap water diluted with decalcified water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Fluctuations from these conditions were noted, but were considered not to have affected study integrity.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 60 mg (60 +/- 1 mg per animal)
- Concentration (if solution): not applicable, the substance was tested as received
Duration of treatment / exposure:
Not applicable (the eyes were not rinsed)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
TREATMENT:
The test substance was instilled in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable

SCORING SYSTEM: The irritation was assessed according to OECD 405

TOOLS USED TO ASSESS SCORE:
- In case standard lighting was considered inadeguate for observing minor effects, eye examinations were performed using a pocket flash light.
- Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
- In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission, Washington, D.C. 20207 was used for additional control purposes.

OTHER OBSERVATIONS
- Mortality/Viability/Toxicity: Daily.
- Body Weight: Day 1 of test (day of treatment)
- Necropsy: Not performed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
other: animal #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
other: animal #1 and #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: animal #1 and #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
other: animal #1 and #2
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: Mean value of score at 24, 48 and 72 h after installation
Score:
0
Max. score:
4
Irritant / corrosive response data:
- Instillation of KY-ET into one eye of each of the 3 male albino rabbits affected the iris in animal #2 and the conjunctivae in all 3 animals
- The iridic irritation had resolved within 48 hours after instillation and the irritation of the conjunctivae had resolved within 72 hours in the animals
Other effects:
- No staining of peri-ocular tissues by the test substance was observed
- No toxic symptoms were observed in the animals during the test period and no mortality occurred

Any other information on results incl. tables

- There was no evidence of ocular corrosion

- Treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation revealed no corneal epithelial damage in any of the animals

- 1 hour after instillation, remnants of test substance were noted in the treated eyes

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study with rabbits, performed according to OECD 405 (1987) and EU Method B.5 (1984) and according to GLP principles, limited irritation was observed.
Executive summary:

Under the conditions of this study, KY-ET resulted in adverse effects on the conjunctivae in all three animals, which had resolved within 72 hours after instillation, and iridic irritation in one animal, which had resolved within 48 hours after instillation. Ocular corrosion was not observed in any of the rabbits.

No signs of systemic intoxication were observed during the study period. Based on these results, KY-ET does not have to be classified and has no obligatory labelling requirement for eye irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.