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EC number: 950-485-6 | CAS number: -
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 -12 Jan 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Deviations: no initial test using one animal performed; no use of topical anesthetics and systemic analgesics
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 9 October 2017
- Deviations:
- yes
- Remarks:
- no initial test using one animal performed; no use of topical anesthetics and systemic analgesics
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate
- Molecular formula:
- C19H36O6
- IUPAC Name:
- 1-{[1-({1-[(2,2-dimethylpropanoyl)oxy]propan-2-yl}oxy)propan-2-yl]oxy}propan-2-yl 2,2-dimethylpropanoate
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Jla:JW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 15 weeks
- Weight at study initiation: 2.49 to 2.78 kg for 100% test article formulation group and 2.60 to 2.78 kg for 10% test article formulation group
- Housing: individual housed in aluminum cages with wire mesh bottoms
- Diet: RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot No. 080916), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5
- Humidity (%): 55 ± 25
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 8 Jan 2009 To: 12 Jan 2009
Test system
- Vehicle:
- other: liquid paraffine
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 10 and 100% (w/w)
VEHICLE
- Lot/batch no.: PEK3961 (Wako Pure Chemical Industries, Co., Ltd.)
- Duration of treatment / exposure:
- After application of test material eyelids were gently held together for about 1 second in order to prevent loss of the test article formulation
- Observation period (in vivo):
- 1, 24, 48, 72 and 96 h after application
- Number of animals or in vitro replicates:
- 3 per dose group
- Details on study design:
- SCORING SYSTEM:
Draize scoring system and Kay and Calandra method
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein / photographs
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- 100% test material
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Remarks:
- 100% test material
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- 100% test material
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Remarks:
- 100% test material
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- 10% test material in liquid paraffine
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- iris score
- Remarks:
- 10% test material in liquid paraffine
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- 10% test material in liquid paraffine
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- chemosis score
- Remarks:
- 10% test material in liquid paraffine
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: bot applicable
- Irritant / corrosive response data:
- In the 100% test article formulation group, conjunctival redness (score 1) and discharge (score 1) were observed in all and 1/3 animals, respectively, at 1 h after application. In the 10% test article formulation group, conjunctival redness (score 1) and discharge (score 1) were observed in all animals at 1 h after application. However, these conjunctival changes in both groups had disappeared completely at 24 h after application. There were no abnormalities in the cornea or iris, and no other ocular changes were observed in either group.
- Other effects:
- - Other observations: No abnormal clinical signs or abnormalities on body weight were observed in any animal of either group during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the performed test, the test substance does not meet the classification criteria according to Regulation(EC) No. 1272/2008.
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