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Registration Dossier
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EC number: 642-902-2 | CAS number: 163802-53-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 January - 05 July, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- An in vivo study was conducted because at the time the study was commissioned the available OECD test guidelines for in vitro eye irritation were not validated for silicon-containing substances.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate
- EC Number:
- 642-902-2
- Cas Number:
- 163802-53-7
- Molecular formula:
- C12H22O5Si
- IUPAC Name:
- 3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate
- Reference substance name:
- 3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate
- IUPAC Name:
- 3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate
- Reference substance name:
- 2,4-Hexadienoic acid, 3-(trimethoxysilyl)propyl ester, (2E,4E)-
- IUPAC Name:
- 2,4-Hexadienoic acid, 3-(trimethoxysilyl)propyl ester, (2E,4E)-
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- The test item was applied at a single dose (0.1 mL) in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The treated eye was not rinsed 24 hours after the application. - Observation period (in vivo):
- The animals were observed for 72 hours after dosing.
- Number of animals or in vitro replicates:
- 3 (male)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Other effects:
- none observed.
Any other information on results incl. tables
There were no significant body weight changes during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single ocular application of the test item2,4-hexadienoic acid, 3-(trimethoxysilyl) propyl ester to rabbits at a dose of 0.1 mL produced no irritant effects.
- Executive summary:
The study was performed in order to assess the potential of the test item to induce the irritant and/or corrosive effects on eyes when applied to rabbits. Animals were exposed to 0.1 mL of the test item administered as a single dose in the conjunctival sac of one eye. The lids were gently held together for about 1 second in order to prevent loss of the test item. The eyes were examined 1 hour and then 24, 48, and 72 hours after the application of the test item. Three male New Zealand White rabbits (Crl: KBL (NZW)) were selected for testing. An initial test was conducted with one of the animals to determine if the test item produced significant irritation. The test item was applied to the two remaining animals selected for testing when the initial test showed that the test item was neither corrosive nor a severe irritant. During the initial test, no irritant or corrosive effects were observed for animal no. 1 following the administration of the test item. In addition, no irritation was observed at any of the scoring intervals for the remaining two animals selected for testing. The study was terminated at the end of the 72 hour observation period. Under the conditions of the present study, a single ocular application of the test item 2,4 -hexadienoic acid, 3-(trimethoxysilyl) propyl ester to rabbits at a dose of 0.1 mL produced no irritant effects.
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