Registration Dossier
Registration Dossier
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EC number: 941-981-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (purity: 80%)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (2012)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
- EC Number:
- 941-981-3
- Molecular formula:
- not available, substance is UVCB
- IUPAC Name:
- Fatty acids, C18 unsaturated, ethyl & methyl esters
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Sevices (no further details)
- Age at study initiation: 11 weeks
- Weight at study initiation: 1956 - 2168 g
- Housing: individually housed in suspended stainless steel caging
- Diet: Harlan Teklad Global High Fiber Rabbit Diet #2031, a designated amount of the diet (approximately 150 g/day) and a Premium Timothy Cube (Ontario Dehy Inc.) were available to each rabbit
- Water: filtered tap water, ad lbitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 53 - 56
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Prior to instillation, 1 - 2 drops of ocular anesthetic (Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%) were placed into both the treated and control eye of each animal. - Duration of treatment / exposure:
- single instillation (no washing)
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: wight light source, fluorescein dye evaluation in the treated eye 24 h after administration
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility: not applicable
- Irritant / corrosive response data:
- No local, occular effects indicative for eye irritation have been observed in any test animal at any reading time point.
- Other effects:
- All animals appeared active and healthy and gained body weight during the study. There was no ocular irritation or other signs of gross toxicity, adverse clinical effects, or abnormal behavior.
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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