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Diss Factsheets

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:
From May 14, 2001 to May 25, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
Molecular formula:
C16H28O5
IUPAC Name:
Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
Constituent 2
Chemical structure
Reference substance name:
Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
Molecular formula:
C17H30O5
IUPAC Name:
Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
Constituent 3
Chemical structure
Reference substance name:
glycerol 1,3-dineodecanoate
Molecular formula:
C23H44O5
IUPAC Name:
glycerol 1,3-dineodecanoate
Constituent 4
Reference substance name:
Sum of other constituents, each of them at <1%
Molecular formula:
Not available
IUPAC Name:
Sum of other constituents, each of them at <1%
Test material form:
liquid
Specific details on test material used for the study:
Batch no.: F016143 05
Appearance: Light-yellow, clear viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Charles River Wiga, D-97633
Acclimatization: 5 days
Body weight: 2.1-2.3 kg
Temperature: ca. 20.3°C, relative humidity : ca. 58.8% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin 2123, ad libitum
Water: tap water for human consumption, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
one application
Observation period (in vivo):
1, 24, 48 and 72h after application
Number of animals or in vitro replicates:
3
Details on study design:
- 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent loss of the test substance. The left eyes remained untreated and served as a control.
- Both eye were examinated within 24h before the instillation and approximately 1, 24, 48 and 72h after the application. The whole eyes, especially the corneas, the irises and the conjunctivae were examinated using an otoscope lamp.
- Mean data of the eye examination scores of each animal (means of the 24, 48 and 72h) for cornea opacity, iris lesions, conjunctival redness and conjunctival oedema were calculated and were classified according to the EEC Ocular Evaluation Criteria. For each group, ocular scores for each parameter (corneal opacity x area, iritis and conjunctival redness + swelling + discharge) were multiplied by the appropriate factor and totals added for each animals per interval according to the method of Draize. The group mean irritation scores were calculated at each scoring interval. The 24, 48 and 72h mean irritation scores were added and the sum divided by 3 to obtain the overall irritation score.
- In addition, the animals were observed for other than local changes at all observation times. Body weights were rmeasured at the start and at the end of the test. Genral signs of toxicity were recorded once daily.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 0
Max. score:
0
Reversibility:
other: no effects were seen
Remarks:
no effects were seen
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
All eyes treated with the test substance were normal before the instillation and at any observation time. The mean scores of all parameters investigated were 0.0 for each animal and the overall irritation score was 0.0 at any observation time. All untreated eyes were normal throughout the test.
Other effects:
No general toxic effects of the test substance were observed.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Remarks:
does not need to be classified
Conclusions:
Under the study conditions, the test substance was considered not irritating to rabbit eye.
Executive summary:

An in vivo study was conducted to determine the eye irritation of the test substance according to OECD Guideline 405, EU Method B.5 and EPA OPPTS 870.2400, in compliance with GLP. 0.1 mL of the test substance was administered per rabbit (New-Zealand White females) into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The left eyes remained untreated and served as a control. Both eye were examined within 24h before the instillation and approximately 1, 24, 48 and 72h after the application. The whole eyes, especially the corneas, the irises and the conjunctivae were examined. Mean data of the eye examination scores of each animal (means of the 24, 48 and 72h) for cornea opacity, iris lesions, conjunctival redness and conjunctival oedema were calculated and were classified according to the EEC Ocular Evaluation Criteria. For each group, ocular scores for each parameter (corneal opacity x area, iritis and conjunctival redness + swelling + discharge) were multiplied by the appropriate factor and totals added for each animals per interval according to the method of Draize. The group mean irritation scores were calculated at each scoring interval. The 24, 48 and 72h mean irritation scores were added and the sum divided by 3 to obtain the overall irritation score. In addition, the animals were observed for other than local changes at all observation times. Body weights were measured at the start and at the end of the test. General signs of toxicity were recorded once daily. No general toxic effects of the test substance were observed. All eyes treated with the test substance were normal before the instillation and at any observation time. The mean scores of all parameters investigated were 0.0 for each animal and the overall irritation score was 0.0 at any observation time. All untreated eyes were normal throughout the test. Under the study conditions, the test substance was considered not irritating to rabbit eye (Wolf, 2001).