Registration Dossier
Registration Dossier
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EC number: 245-122-7 | CAS number: 22613-51-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970s-1980s
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-acetoxyethyl stearate
- EC Number:
- 245-122-7
- EC Name:
- 2-acetoxyethyl stearate
- Cas Number:
- 22613-51-0
- Molecular formula:
- C22H42O4
- IUPAC Name:
- 2-acetoxyethyl stearate
- Reference substance name:
- Reference substance 002
- Cas Number:
- 8001-25-0
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- other: olive oil
- Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- 1, 6, 10, 24, 48 and 72h
- Number of animals or in vitro replicates:
- 6
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:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Conclusions:
- CLP criteria not met
- Executive summary:
The introduction into eyes of 0.2 ml of a 3% AGS solution in olive oil, without washing, caused in 2 of the 6 rabbits the injection of few conjunctival vessels. Recovery was complete within 48 h. The results showed no irritant activity on the rabbits' eye. The results obtained indicate that, at concentration tested, AGS is practically devoid of any significant irritant activity. In fact, according to the method, a material is considered irritant if 4 or more animals, in a test group of 6 rabbits, exhibit a positive reaction in any tissue.
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