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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 August - 25 September 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405) and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
IN 78281
IUPAC Name:
IN 78281
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): IN00078281 (IN78281)
- Physical state: White powder
- Analytical purity: The Certificate of Analysis was provided to the Study Director.
- Lot/batch No.: 7889-058-10
- Expiration date of the lot/batch: dec 2006
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: Stability data on bulk test material was not provided to the Study Director
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Oxford, MI
- Age at study initiation: 20 weeks at start of dosing
- Weight at study initiation: 2.5-3.0 kilograms
- Housing: individually housed according to USDA Guidelines
- Diet (e.g. ad libitum): ad libitum, PMI Certified Hi-Fiber Rabbit Diet #5325
- Water (e.g. ad libitum): ad libitum, tab water
- Acclimation period: Study animals were acclimated to their housing for a minimum of five days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 32 to 74%
- Air changes (per hr): The room in which the animals were kept was documented in the study records
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after exposure
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
The eye irritation scored were evaulated according to the scoring system by Kay JH and Calandra JC (1962) and OECD 405



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0

Any other information on results incl. tables

No ocular irritation involving the cornea or iris was observed in the test-treated eyes during the study. Non-positive conjunctival redness was observed in 3 of 3 animals at 1 hour. No signs of irritation were observed in any of the animals at 24, 48 or 72 hours post treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, IN 78281, was found to be practically non-irritating to the eyes of rabbits with a MMTS score of 2.0.