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EC number: 619-598-5 | CAS number: 915095-87-3
Eye irritation
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- 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
- Reference substance name:
- (3S)-3-[4-(2-chloro-5-iodobenzoyl)phenoxy]oxolane
- EC Number:
- 619-598-5
- Cas Number:
- 915095-87-3
- Molecular formula:
- C17 H14 Cl I O3
- IUPAC Name:
- (3S)-3-[4-(2-chloro-5-iodobenzoyl)phenoxy]oxolane
- 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
Constituent 1
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:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
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:
- GHS criteria not met
- 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.
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