Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
