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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guedeline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
SafePharm Laboratories Limited, Shardlow, Derbyshire, UK

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oxooil HS9
- Physical state: pale yellow liquid
- Analytical purity: not stated
- 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: RarIan UK Limited, Bicester, Oxon, UK
- Age at study initiation: the animals were twelve to twenty weeks old
- Weight at study initiation: mean: 2.82 kg
- Housing: individually
- Diet: Certified Rabbit Diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least five days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Duration of treatment / exposure:
72 h (no washing out conducted)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 male animals
Details on study design:
SCORING SYSTEM: OECD 405 / Assessment of ocular damage/irritation was made according to Draize J. H. (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49. Using the numerical data obtained a modified version of the system described by Kay J. H. and Calandra J. C. (1962), J. Soc. Cosmet. Chem. 13, 281-289 was used to classify the ocular irritancy potential of the test material.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the 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:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal 1- 3)
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: chemosis (score 1) 1 h after substance instillation in all animals
Irritant / corrosive response data:
No corneal or iridial effects were noted. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in two treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation.
Other effects:
All animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

    Cornea Iris Conjunctiva
Animal  Reading  Opacity Area involved Redness Chemosis Discharge
1 1 h 0 0 0 2 1 1
2 1 h 0 0 0 1 1 1
3 1 h 0 0 0 1 0 1
1 24 hrs 0 0 0 1 0 0
2 24 hrs 0 0 0 1 0 0
3 24 hrs 0 0 0 1 0 0
1 48 hrs 0 0 0 0 0 0
2 48 hrs 0 0 0 0 0 0
3 48 hrs 0 0 0 0 0 0
1 72 hrs 0 0 0 0 0 0
2 72 hrs 0 0 0 0 0 0
3 72 hrs 0 0 0 0 0 0
mean animal 1 24/48/72 hrs 0.0   0.0 0.3 0.0  
mean animal 2 24/48/72 hrs 0.0   0.0 0.3 0.0  
mean animal 3 24/48/72 hrs 0.0   0.0 0.3 0.0  
mean animal 1-3 24/48/72 hrs 0.0   0.0 0.3 0.0  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU