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Registration Dossier
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EC number: 943-350-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-10-23 to 1984-10-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Complete guideline conform study report available. Study is performed under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
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:
- Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers
- EC Number:
- 943-350-8
- Molecular formula:
- not applicable (UVCB)
- IUPAC Name:
- Reaction products resulting from the esterification of C18 unsaturated fatty acid with glycerol and glycerol oligomers
Constituent 1
- Specific details on test material used for the study:
- - Chemical name: Diglycerinsesquioleat
- Purity: about 100 %
- Lot No. FMFP355
- Appearance: yellow liquid
- Storage: In the dark at about 22°C
- Solubility: not soluble in water, soluble in most organic solvents
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- In order to assess the eye irrtating potential of the test substance, 0.1 g of the undiluted test item was applied into the conjunctival sac of the left eye of each rabbit. The untreated eye serves as control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no adverse effect observed
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.
- Executive summary:
In order to assess the eye irritating potential of the test substance, 0.1 ml of the undiluted test item was applied into the conjunctival sac of the left eye of each of 3 rabbits. The untreated eye serves as control. After one hour the treated eye was washed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48 and 72 hours after application of test item. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:
- No mortality or signs of systemic toxicity occurred.
- Hyperemia was observed in two of three animals at the 24 hour time point (score 1 -1 -0). This effect was reversible within 48 hours.
- No Chemosis of the conjunctiva was observed in all animals 24, 48 and 72 hours after application (score 0-0-0).
- No Corneal opacity were observed in all three animals 24, 48 and 72 hours after application of the test substance (score 0-0-0).
- No effects at Iris was observed in all animals 24, 48 and 72 hours after application of the test substance (score 0-0-0).
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.
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