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EC number: 293-215-6 | CAS number: 91052-54-9
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 May - 27 May 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. Lack of details on test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- lack of details on test material
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glycerides, C16-18 mono-, di- and tri-
- EC Number:
- 293-215-6
- EC Name:
- Glycerides, C16-18 mono-, di- and tri-
- Cas Number:
- 91052-54-9
- Molecular formula:
- C19H38O4; C21H42O4; C35H68O5; C39H76O5; C51H98O6; C57H110O6
- IUPAC Name:
- Glycerides, C16-18 mono-, di- and tri-
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: white powder
- Analytical purity: no data
- Storage condition of test material: at 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: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.42-3.02 kg
- Housing: animals were individually housed in suspended metal cages.
- Diet: Rabbit Diet (Preston Farmers Ltd., New Leake, Boston, Lincolnshire, UK), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19
- Humidity (%): 65-75
- Air changes (per hr): approx. 15
- 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 (as measured by gently compacting the required volume into an adapted syringe), which was found to weigh ca. 0.072 g. - 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:
- 1 male and 5 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 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 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: 2 animals scored 1 at 24 h; 4 animals scored 0 at 24-72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 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:
- 1 h post-instillation: slight iritis was observed in 2/6 animals, being fully reversible at the 24 h reading. Slight and moderate conjunctival redness was observed in 1 and 5/6 animals, respectively. Effects were fully reversible at the 24 h reading in 4/6 animals.Very slight and slight swelling was observed in 3 and 3/6 rabbits, respectively, the effects being fully reversible at the 24 h reading. All animals showed slight discharge at this, but not at the following reading time points.
24 h post-instillation: slight conjunctival redness was observed in 2/6 animals. Effects were fully reversible after 24 h (48 h post-instillation).
48-72 h post-instillation: no eye effects were noted in any animal. - Other effects:
- No further local or systemic effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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