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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 06, 2007-November 19, 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 Resin 5
- Substance type: UVCB
- Physical state: beige solid granules
- 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:
Amount applied: 0.1 ml (average 59.8 mg)
The test substance was ground to a powder using a mortar and pestle prior to weighing.
Duration of treatment / exposure:
After 24 hours observation, a solution of 2% fluorescein in water was instilled in both eyes to determine corneal epithelial damage.
Observation period (in vivo):
7 days
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:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0 - 0.3
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0 - 0.3
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0.3 - 1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Corneal injury was observed in one animal and consisted of slight dulling of the normal lustre of the cornea and epithelial damage (maximum 15%).
There was no evidence of ocular corrosion.
Remnants of the test substance were present in the eye on Day 1.
No staining of (peri) ocular tissues by the test substance was observed.

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.