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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.
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