Corsair Clear #12

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Corsair Clear #12
- Substance type: Soft waxy beige 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
- Amount(s) applied (volume or weight with unit): 0.1 ml

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

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Time point:

other: 24, 48, and 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

Instillation of 0.1 mL of Corsair Clear #12 into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and/or discharge. The irritation had completely resolved within 24 hours. No iridial irritation or corneal opacity were observed and treatment of the eyes with 2% fluorescein, 24 hours after test substance instillation, revealed no corneal epithelial damage.

Other effects:

None.

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.