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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 07, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
other: Bovine eyes
Strain:
other: Corneas

Test system

Controls:
yes

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
3.01
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Corneal Opacity :
The opacity reading for the test article was 2.67, 1.67 and 4.67.
The mean opacity reading for the negative control was 1.33.
The opacity reading for the positive control was 78.67, 74.67 and 81.67.

Corneal Permeability:
The optical density for the test article was 0.004, 0.001 and -0.003.
The mean optical density for the negative control was 0.048.
The optical density for the positive control was 0.486, 0.209 and 0.318.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
According to the current study and under the experimental conditions reported, the test item SINODOR CQ U/A - 6099932 is not corrosive to the eye.