Registration Dossier
Registration Dossier
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EC number: 234-398-4 | CAS number: 11140-04-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 6th - April 11th, 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- purity of test substance not given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- purity of test substance not given
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octanoic acid, ester with 1,2,3-propanetriol
- EC Number:
- 234-398-4
- EC Name:
- Octanoic acid, ester with 1,2,3-propanetriol
- Cas Number:
- 11140-04-8
- Molecular formula:
- C8H16O2.xC3H8O3
- IUPAC Name:
- Octanoic acid, ester with 1,2,3-propanetriol
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- Imwitor 908
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., Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.70 - 3.29 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Ltd., Lincolnshire, U.K.
- Water (e.g. ad libitum): yes
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 167- 20
- Humidity (%): 52 - 58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single eye instillation
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
No
SCORING SYSTEM:
Draize
TOOL USED TO ASSESS SCORE:
standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 tested animals and mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 30
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 tested animals and mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.6
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 tested animals and mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.9
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7d
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
- Executive summary:
The test material, octanoic acid, ester with 1,2,3-propanetriol, was found to be a moderate irritant to the rabbit eye.
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