Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 May 1999 - 07 May 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EEC Directive 92/69/EEC, Annex V, Test 85, July 1992
GLP compliance:
yes
Remarks:
OECD Principles of Good Laboratory Practice, Statutory Instrument No. 654, 1997, ISBN 0-11- 064105-1

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
white, 99.9% purity. Stored in dark at ambient temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Age at study initiation: 3 months
- Weight at study initiation: 2.37-2.71 kg
- Housing: individually in stainless steel cages (dimensions 77.2 x 70.1 x 48 cm) with a Noryl moulded dual level interior and perforated floor beneath which was an absorbent paper lined tray
- Diet: Teklad Diet supplied by Harlan UK was available ad libitum. Each animal was also offered a supplement of hay or organically grown cabbage ca. twice weekly
- Water: Domestic mains quality water was available ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C - 21°C
- Humidity (%): 57%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other: left eye of each animal was untreated
Amount / concentration applied:
Amount instilled (weight equivalent of 0.1 ml)
0.0365 g - Animal 1
0.0365 g - Animal 2
0.0363 g - Animal3
Duration of treatment / exposure:
0.0365 g of test material was placed into the right eye of three rabbits by gently pulling the lower eye lid away from the eyeball to form a sac into which the test material was dropped. The lids were then gently held together for 1-2 seconds. The left eye was left untreated to serve as the control.
Observation period (in vivo):
One rabbit was treated first and observed for signs of severe irritation for up to 24 hours. As none were noted, the remaining 2 rabbits were treated in the same way
The eyes were examined using a hand held magnifier and pen torch 1, 24, 48 and 72 hours after instillation of the test material.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
Both eyes of each rabbit were examined prior to dosing and no ocular defects were detected.
All the animals were examined for reaction to treatment. The onset, intensity and duration of any signs were recorded.
The eyes were examined using a hand held magnifier and pen torch 1, 24, 48 and 72 hours after instillation of the test material.

Results and discussion

Any other information on results incl. tables

 

Area of Eye

Animal/BodyWeight(kg)/Time After Instillation

1

2

3

3.83

3.56

3.83

1h

24h

48h

72h

1h

24h

48h

72h

1h

24h

48h

72h

 

Cornea:

 

 

0

 

 

0

 

 

0

 

 

0

 

 

0

 

 

0

 

 

0

 

 

0

 

 

0

 

 

0

 

 

0

 

 

0

Degree/Opacity

Area/Opacity

0

0

0

0

0

0

0

0

0

0

0

0

Iris

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae:

 

 

 

 

 

 

 

 

 

 

 

 

Redness

0

0

0

0

0

0

0

0

0

0

0

0

Chemosis

0

0

0

0

0

0

0

0

0

0

0

0

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

h= hours

Acute Eye Irritation Test in Rabbits Scoring System

CORNEA

 

Opacity:          Degree of Density (area most dense taken for reading)

 

No ulceration or opacity.········································································0

Scattered or diffuse areas of opacity (other than slight dulling of normal

lustre) details of iris clearly visible...............................................1

Easily discernible translucent area, details of iris slightly obscured..............................2

Nacreous area, no details or iris visible, size of pupil barely discernible··············· ··3

Opaque cornea, iris not discernible through the opacity.............................................4

 

Area of Opacity

 

A quarter (or less) but not more...........................................................1

Between a quarter and a half...............................................................2

Between half and three quarters  ·····-··········-·············----······---3

Between three quarters and the whole surface ....................................4

 

  IRIS

 

Normal ............. ................................................................................................0

Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof,

iris still reacting to light (sluggish reaction is positive)...............................................1

No reaction to light, haemorrhage, gross destruction (any or all of these)..................2

 

CONJUNCTIVAE

 

Redness:           (refers to palpebral and bulbar conjunctivae, cornea and iris)

 

Bloodvessels normal ··--··-······-·-·-···-···-·········-·········-·--·····O

Some blood vessels definitely hyperaemic (injected)·····-····-·-······1

Diffuse,crimson colour, individual vessels not easily discernible··-·-·2

Diffuse beefy red ··-·--··-····-····-······--·-··········-········-·-·······3

Chemosis:     lids and/or nictitating membranes

 

No swelling            -··········-··················--···················O

Any swelling above normal (includes nictitating membrane).......1

Obvious swelling with partial eversion of lids·-······-····-·-····2

Swelling with lids about half closed···-·-··..······-·-·-············3

Swelling with lids more than half closed-····-··-·-----····-··-··--4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the study, it is considered that the test substance is not irritating to the rabbit eye.
No responses were noted in any animal during any of the observation periods.
Executive summary:

One group of three female rabbits was treated with the weight equivalent of

0.1ml of the test material instilled into the conjunctival sac of one eye. The treated eye was then examined for evidence of irritation 1,24, 48 and 72 hours after instillation.

No responses were noted in any animal during any of the observation periods.