Registration Dossier
Registration Dossier
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EC number: 406-690-3 | CAS number: 43136-14-7 MDI/ODA
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data available, ECHA provided study summaries migrated from the SNIF format.
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
- EC Number:
- 406-690-3
- EC Name:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
- Cas Number:
- 43136-14-7
- Molecular formula:
- C51H88N4O2
- IUPAC Name:
- 3-octadecyl-1-[4-({4-[(octadecylcarbamoyl)amino]phenyl}methyl)phenyl]urea
- Test material form:
- other: No data available, ECHA provided study summaries migrated from the SNIF format.
- Details on test material:
- No data available, ECHA provided study summaries migrated from the SNIF format.
Constituent 1
Test animals / tissue source
- Species:
- other: Rabbit (New Zealand White)
Test system
- Amount / concentration applied:
- 66 MG
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- Following fluorescein application to the eyes of all three animals at 24 hours, 30% of the total cornea area in animal number 2 was stained indicating epithelial damage. A repeat of fluorescein treatment at 72 hours yielded negative findings.
Immediately after fluorescein examination at 24 hours, both eyes of all three animals were rinsed with water. Residual test substance remained in the eye of animal no. 3.
Any other information on results incl. tables
Comments: 66 mg of powder is equivalent to 0.1 ml of bulk substance.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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