Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 October 1992 to 16 October 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

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)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Appearance: Dark yellow powder
- Storage conditions of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 12 to 16 weeks old
- Weight at study initiation: 2.50 to 3.18 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: ad libitum access to food
- Water: ad libitum access to mains drinking water
- Acclimation period: A minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 20 °C
- Humidity: 54 to 59 % (relative)
- Air changes: approximately 15 changes per hour
- Photoperiod: Lighting was controlled by a time switch to give 12 hours of continuous light and 12 hours of continuous darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL of the test material which was found to weigh approximately 62 mg (as measured by gently compacting the required volume into an adapted syringe).
Duration of treatment / exposure:
The upper and lower eyelids were held together for about one second immediately after application to prevent loss of the test material, and were then released.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3; 2 males and 1 female
Details on study design:
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope.

INSTALLATION OF TEST MATERIAL
One rabbit was initially treated. The test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. Immediately after administration of the test material an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on installation of the test material, one drop of local anaesthetic (Ophthaine, 0.5 % proxymetacaine hydrochloride) was instilled into both eyes of the third animal 1 - 2 minutes before treatment.

REMOVAL OF TEST MATERIAL
- Washing: No

SCORING SYSTEM
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize scale. Any other adverse ocular effects were also noted.

TOOL USED TO ASSESS SCORE
Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all three animals
Time point:
other: Mean of the 24, 48 and 72 hour examinations
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all three animals
Time point:
other: Mean of the 24, 48 and 72 hour examinations
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
of all three animals
Time point:
other: Mean of the 24, 48 and 72 hour examinations
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all three animals
Time point:
other: Mean of the 24, 48 and 72 hour examinations
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
of all three animals
Time point:
other: Mean of the 24, 48 and 72 hour examinations
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The individual scores are presented in Table 2.
No adverse corneal effects were noted during the study. Iridial inflammation was noted in two treated eyes one hour after treatment; no other adverse iridial effects were noted.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation.
No adverse ocular effects were noted 24 to 48 hours after treatment.
Other effects:
Residual test material was noted around the treated eye of all animals throughout the study.

Any other information on results incl. tables

Table 2: Individual Scores for Ocular Irritation

 

276 Male

239 Male

281 Female

Examination Interval (hours)

24

48

72

24

48

72

24

48

72

Cornea

Degree of opacity

 

0

 

0

 

0

 

0

 

0

 

0

 

0

 

0

 

0

Iris

0

0

0

0

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

 

1

0

1

 

0

0

0

 

0

0

0

 

0

0

0

 

0

0

0

 

0

0

0

 

1

0

0

 

0

0

0

 

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test material was found to be non irritating to the eye.
Executive summary:

The irritancy potential of the test material was investigated in a study conducted in accordance with the standardised guidelines OECD 405 and EU Method B.5 under GLP conditions.

A single application of the neat test material was made to the non-irrigated eye of three New Zealand White rabbits. One rabbit was initially treated. Immediately after administration of the test material an assessment of the initial pain reaction was made.

After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on installation of the test material, one drop of local anaesthetic (Ophthaine, 0.5 % proxymetacaine hydrochloride) was instilled into both eyes of the third animal 1 to 2 minutes before treatment.

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize scale. Any other adverse ocular effects were also noted.

No adverse corneal effects were noted during the study. Iridial inflammation was noted in two treated eyes one hour after treatment; no other adverse iridial effects were noted. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation. No adverse ocular effects were noted 24 to 48 hours after treatment.

Under the conditions of this study the test material was found to be non irritating to the eye.