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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
2-Propenoic acid, C12-14-alkyl esters
EC Number:
282-516-8
EC Name:
2-Propenoic acid, C12-14-alkyl esters
Cas Number:
84238-60-8
Molecular formula:
Unspecified
IUPAC Name:
84238-60-8

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Amount applied: 0.1 mL
Duration of treatment / exposure:
168 hour(s)
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritant / corrosive response data:
No eye irritation was observed in this study 24 hours after exposure

Any other information on results incl. tables

The test compound caused slight lesions of the conjunctivae in all  rabbits. After 24 hours these lesions had subsided completely.

Individual eye irritation scores:
---------------------------------
 
rabbit         cornea          iris             conjunctivae                     Total score
          opacity   area                 redness  chemosis  discharge     
-------------------------------------------------------------------------- -----------------
                                       after 1 hour
  1          0       0           0          1         0         0                    2
  2          0       0           0          1         1         0                    4
  3          0       0           0          1         0         0                    2
  4          0       0           0          1         0         0                    2
  5          0       0           0          1         0         0                    2
  6          0       0           0          1         0         0                    2

                                        after 24 hours
  1          0       0           0          0         0         0                    0
  2          0       0           0          0         0         0                    0
  3          0       0           0          0         0         0                    0
  4          0       0           0          0         0         0                    0
  5          0       0           0          0         0         0                    0
  6          0       0           0          0         0         0                    0

After 48, 72 hours and 7 days all scores were recorded as 0.
-------------------------------------------------------------------------- ------------------

Mean values over 24, 48, and 72 hours for the single animals for cornea,  iris and conjunctivae were without exception zero.  
Thus, the eye irritation score was calculated to be zero.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the available data, the test item is not considered to be eye irritating in rabbits.
Executive summary:

In this in vivo eye irritation study, six healthy adult New Zealand White albino rabbits were used for the test substance. The eyes of the animals were examined before testing and only those animals without observable eye defects are used. 0.1 mL of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid were then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.The other eye remaining untreated, served as a control. The eyes were not washed following instillation.The eyes were examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material. Eye reactions were evaluated by the method published by Draize and Kelley (1952). After 48, 72 hours and 7 days all scores were recorded as 0. No eye irritation was observed in the study.

Based on the results, the test substance is considered to be not irritating to the eyes.