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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-793-6 | CAS number: 126-57-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent well documented GLP study according to international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate
- EC Number:
- 204-793-6
- EC Name:
- 2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate
- Cas Number:
- 126-57-8
- Molecular formula:
- C33H62O6
- IUPAC Name:
- 2,2-bis[(nonanoyloxy)methyl]butyl nonanoate
- Test material form:
- liquid: viscous
- Details on test material:
- Details of the test item received at RTC were as follows:
Identity: Trimethylolpropane Tripelargonate
Label name: Trimetilolpropano Tripelargonato
IUPAC name: Nonanoic acid, 1,1’-[2-ethyl-2-[[(1-oxononyl)oxy)methyl]-1,3-propanediyl]ester
Batch no.: P_F54 + P_MAGGIO 2013
CAS Number: 126-57-8
EINECS number: 204-793-6
Expiry date: 30 November 2014
Storage conditions: Room temperature, protected from light
RTC Number: 14050
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The eye of each animal treated with the anaesthetic but not with the test item served as control.
- Duration of treatment / exposure:
- Animals were dosed once only on the day of dosing (Day 1). Each animal was treated with 0.1 mL aliquot of the test item onto the right eye.
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after the end of dosing.
- Number of animals or in vitro replicates:
- 3 animals/group
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h post-dose observation.
- Score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 0 - 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 0 - 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 0 - 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 0 -72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 0 - 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 0 - 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 0 - 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 0 - 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 0 - 72h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- These results indicate that the test item, Trimethylolpropane Tripelargonate, has no relevant irritating effect on the eye of the rabbit.
- Executive summary:
The acute eye irritation of Trimethylolpropane Tripelargonate was investigated in rabbits. A 0.1 mL aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed approximately 1, 24, 48, and 72 hours after dosing. No significant irritation at either the conjunctivae, iris or cornea was recorded in any treated animal during the study. There were no signs of pain/distress after dosing. Changes in body weight were not remarkable. There was no indication of a systemic effect related to treatment. These results indicate that the test item, Trimethylolpropane Tripelargonate, has no relevant effect on the eye of the rabbit.
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.
