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Toxicological information

Eye irritation

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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
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

Constituent 1
Chemical structure
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
Constituent 2
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)-
Constituent 3
Reference substance name:
3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate
IUPAC Name:
3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate
Test material form:
liquid

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:
other: 24, 48, 72 hours
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:
other: 24, 48, 72 hours
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:
other: 24, 48, 72 hours
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:
other: 24, 48, 72 hours
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.