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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
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:
2020
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.