Registration Dossier
Registration Dossier
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: 701-350-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th November- 10th November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione
- EC Number:
- 701-350-3
- Molecular formula:
- Not possible to assign, UVCB
- IUPAC Name:
- 3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione
- Test material form:
- liquid
- Details on test material:
- - Appearance: brown liquid
- Storage: room temperature, in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Male New Zealand White Rabbits ten to twelve weeks old, weighing between 2.57 and 2.70 kilograms at the start of the study were individually housed in stainless stell cages in a temperature, humidity and light controlled room. Purina Rabbit chow and water were available ad libitum. The animals were conditioned for at least 5 days prior to study initiation.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye to treatment served as the untreated control for each rabbit
- Amount / concentration applied:
- 0.1 mL of undiluted test sample
- Duration of treatment / exposure:
- Three animals were dosed by instilling 0.1 mL of the test article into one eye and then holding the eye lids together for one second to prevent loss of the material. The contralateral eye served as the untreated control for each rabbit.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test susbtance is not considered to be irritating to the eye.
- Executive summary:
The test substance was administered into one eye of each of three albino rabbits. The eyes were observed and
scored at 1, 24, 48 and 72 hours. There was minimal irritation observed in all of the test subjects
and the maximum group mean score was 10.67/110.0 at the 1 hour observation. All irritation
cleared within 72 hours. In accordance with GHS and OECD 405 guidelines, the substance is not classified for eye irritation.
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.
