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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, safflower-oil, Et esters
EC Number:
293-106-3
EC Name:
Fatty acids, safflower-oil, Et esters
Cas Number:
91051-53-5
IUPAC Name:
Fatty acids, safflower-oil, Et esters
Test material form:
liquid
Specific details on test material used for the study:
Identification product: SAFESTER A-75, charge 709028
Liquid
Yellowish

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six adult healthy albino rabbits (tattoed New Zealands) were used for the procedure, body weights between 2.9 and 3.1 kg.
They were housed in individual cages, at a standard laboratory diet for rabbits and were watered ad libitum.
The room temperature was kept constantly at 18°C +/- 2°C, the relativs humidity 50-60%, the daily illumination 12hours.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Before and after the test, the eyes of all animals were examined with fluorescin 0.15 p.c., Thilo (R).
After waiting (16 hours starved), 0.1 ml of the substance was applied into the conjunctival pouch of the left eye.
The right eye stayed untreated and served as control.
Observation period (in vivo):
Readings of eye alterations were made after 1, 2, 4, 12, 24, 48, 72 and 96 hours up to 7 days.
Number of animals or in vitro replicates:
6 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1,2,3,4,5,6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal: 1,2,3,4,5,6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal: 1,2,3,4,6
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other:
Remarks:
Vessels clearly more injected than normal
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 1,2,3,4,5,6
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1,2,3,4,5,6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal: 1,2,3,4,5,6
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Under conditions of the experiment, it was found :
1- Later than 24 hours after the application the animals did not show any deviations to normal findings.
Til 24 hours post application very slightly increased secretion for 12 hours p.a also.
At the beginning, 4 out of 6 anmilas did show further a slight chemosis for 4 hours p.a.
2- Eye clinical verification did not show any objection for contact of SAFESTER A-75, charge 709028 in the near eyes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
SAFESTER A-75 can be classified as non-irritating to the eye.
Executive summary:

SAFESTER A-75 can be classified as non-irritating to the eye.