Registration Dossier
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EC number: 946-248-1 | CAS number: -
Eye irritation
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:
- 2 012
- 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.
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