Registration Dossier
Registration Dossier
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EC number: 293-106-3 | CAS number: 91051-53-5
Eye irritation
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:
- 1 988
- 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
- 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
Constituent 1
- 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.
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