Registration Dossier
Registration Dossier
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EC number: 807-674-2 | CAS number: 109884-54-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 - 29 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2012)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 109884-54-0
- Cas Number:
- 109884-54-0
- IUPAC Name:
- 109884-54-0
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: clear colourless liquid
- Analytical purity: 100%
- Batch No.: OE31003999
- Expiration date of the batch: 03 October 2017
- Storage condition of test material: at room temperature in the dark
- pH (1% in water, indicative range): 6.5 - 5.7
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: 12 - 24 weeks
- Weight at study initiation: at least 1.5 kg
- Housing: individually housed
- Diet: pelleted diet for rabbits appr. 100 g per day, hay and wooden sticks
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required (the untreated eye served as control)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- PREEMPTIVE PAIN MANAGEMENT
One hour prior to instillation of the test substance, buprenorphine 0.01 mg/kg was administered by subcutaneous injection in order to provide a therapeutic level of systemic analgesia.
Five minutes prior to instillation of the test substance, two drops of the topical anesthetic lidocaïne eyedrops were applied to both eyes.
POST-TREATMENT OF THE ANIMALS
On Day 2, buprenorphine 0.01 mg/kg and meloxicam 0.5 mg/kg were administered by subcutaneous injection to provide a continued level of systemic analgesia.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 2% fluorescein in water (adjusted to pH 7.0)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Instillation of 0.1 mL of test substance into one eye of each of three rabbits resulted in slight irritation of the conjunctivae, which consisted of redness in all animals and discharge in one animal. The irritation had completely resolved within 24 hours in all animals.
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.
There was no evidence of ocular corrosion. - Other effects:
- No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
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