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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
Study period:
November 6 - 15, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

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
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Corsair Clear #34
- Substance type: Clear white lumpy solid
- Physical state: Solid
- Stability under test conditions: Stable
- 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:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands.
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: Individually in labeled cages with perforated floors
- Diet (e.g. ad libitum): approximately 100 grams per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8 – 22.6°C
- Humidity (%): 44 - 73%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of each rabbit remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL: The test substance was ground to a powder using a mortar and pestle prior to weighing.
- Amount(s) applied (volume or weight with unit): 0.1 ml (60 mg)



Duration of treatment / exposure:
The eyes of the test animals have not been washed.
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal: #2 and #3 means
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #2 and #3 means
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3 means
Time point:
other: 24, 48 and 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Instillation of approximately 60 mg of Corsair Clear #34 (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae.
In one animal, corneal injury was observed and consisted of epithelial damage (maximum 15%). No corneal injury was visible without the use of fluorescein. The corneal injury had resolved within 72 hours.
Iridial irritation grade 1 was observed and had resolved within 24 hours in two animals and within 48 hours in the other animal.
The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 72 hours.
Other effects:
Remnants of the test substance were present in the eye on Day 1 and on the outside of the eyelids on Days 2 and 3.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this in vivo eye irritation test, the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation.