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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.02.2020 - 05.03.2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 405
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of the test item in undiluted form, as a single dose.
- Duration of treatment / exposure:
- The test item was instilled into the conjunctival sac of the left eye of each animal. The eye lids were gently held closed for about one second to prevent the loss of the test item. The contralateral eye served as control.
The eyes of the test animals were not washed out 24 hours after test item application, because the test item had been removed from the eye of test animal by
physiological mechanisms. - Observation period (in vivo):
- The eyes were examined at 1, 24, 48, 72 hours and 1 week after the application. The duration of the observation period was sufficient for the statement of
reversibility or irreversibility of changes.
Any clinical signs of toxicity or signs of pain and/or distress were recorded at least twice daily, with a minimum of 6 hours between observations.
It was no humane sacrificing connected with severe eye lesions during the study. At the end of the observation period the animals were humanely sacrificed
(RELEASE 300 mg/mL sodium-pentobarbital injection). - Number of animals or in vitro replicates:
- Two male animals were selected for the test. As in the initial test slight to moderate irritant effects were observed 24 hous after treatment, the confirmatory test
was conducted using a second animal.
The confirmatory test was not conducted using a third animal, because the results from two animals were sufficient to allow a hazard classification determination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- not fully reversible within: 1 week
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: Mean value considering readings at 24, 48, and 72 hours after the treatment
- Score:
- 1
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- According to GHS Classification Criteria for Eye Irritation/Corrosion, the test item should be classified into "Category 2B Mild Irritant", because the mean value of cornea opacity was 1.00 in both animals and both animals recovered within 7 days.
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