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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 222-264-8 | CAS number: 3398-33-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21/03/2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2012
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:
- Sodium undec-10-enoate
- EC Number:
- 222-264-8
- EC Name:
- Sodium undec-10-enoate
- Cas Number:
- 3398-33-2
- Molecular formula:
- C11H20O2.Na
- IUPAC Name:
- sodium undec-10-enoate
Constituent 1
- Specific details on test material used for the study:
- sodium undec-10-enoate in a 33.2% aqueous solution
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A single dose of 0.1ml of the test substance was instilled into the conjunctival sac of the left eye of one male New Zealand White rabbit.
- Observation period (in vivo):
- the ocular reactions
- Number of animals or in vitro replicates:
- 3
Due to the ocular reactions recorded in the first animal, the study was not undertaken in the 2 other animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 3
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- eleven days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The substance sodium undec-10-enoate ( in a 33.2% aqueous solution) is considered as irritant in the rabbit. the ocular lesions were more marked after 72 jours and were totally reversible on the eleventh day of observation.
- Executive summary:
The eye irritation study was performed according to the OECD 405 guideline. -
A single dose of 0.1ml of the substance sodium undec-10-enoate (in a 33.2% aqueous solution) was instilled into the conjunctival sac of one rabbit.
The substance is considered as eye irritant in 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.
