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:
2002-06-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(adopted 24 February 1987)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
Safepharm Laboratories Limited P.O. Box No. 45 DERBY DEI2BT U.K.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- State of aggregation: liquid
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum; certified Rabbit Diet (Code 5322) supplied by PMI Nutrition International, Nottingham, UK
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: unchanged
Duration of treatment / exposure:
single instillation, eyes not washed out
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males.
Initially, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Conjunctival Discharge observed in all three animals after 1 hour. Minimal conjunctival irritation was noted in all treated eyes one hour after treatment. All treated eyes appeared normal at the 24-hour observation.

Any other information on results incl. tables

Individual Scores

Rabbit Number and sex 81 male 121 male 34 male
IPR = 2 IPR = 2 IPR = 3
Time after treatment (h) 1 24 48 72 1 24 48 72 1 24 48 72
Corneal 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
Conjunctival redness 1 0 0 0 1 0 0 0 1 0 0 0
Chemosis 0 0 0 0 0 0 0 0 0 0 0 0
Discharge 1 0 0 0 2 0 0 0 1 0 0 0

IPR = Initial Pain reaction

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced mean scores (24 - 72 hours) of 0 in all animals for all parameters and did therefore not meet the criteria for GHS classification as irritant.
Executive summary:

An acute eye irritation study according to OECD guideline 405 and in compliance with GLP was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 24-hour observation. The test material produced mean scores (24 - 72 hours) of 0 in all animals for all parameters and was classified as not irritating based on GHS and EU labeling regulations.