Registration Dossier
Registration Dossier
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EC number: 208-237-3 | CAS number: 517-28-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Haematoxylin
- EC Number:
- 208-237-3
- EC Name:
- Haematoxylin
- Cas Number:
- 517-28-2
- Molecular formula:
- C16H14O6
- IUPAC Name:
- haematoxylin
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 30 mg
- Duration of treatment / exposure:
- 10 sec
- Number of animals or in vitro replicates:
- 3 enucleated chicken eyes
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- ca. 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Value:
- ca. 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Value:
- ca. 2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.0, corresponding to ICE class I;
- mean score of fluorescein retention: 3.0, corresponding to ICE class IV;
- maximal mean corneal swelling: 2%, corresponding to ICE class I.
The combination of the three endpoints for the test HEMATOXYLIN HPL (CAS 517-28-2) was 1 x IV, 2 x I.
The combination of the three endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as “No Category”, as expected.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category “no prediction can be made”, as defined by the OECD guideline No.438. Therefore, the test item HEMATOXYLIN HPL (CAS 517-28-2) is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing (in vitro and/or in vivo) are required to establish a definitive classification.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category “no prediction can be made”, as defined by the OECD guideline No.438. Therefore, the test item HEMATOXYLIN HPL (CAS 517-28-2) is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing (in vitro and/or in vivo) are required to establish a definitive classification. - Executive summary:
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category “no prediction can be made”, as defined by the OECD guideline No.438. Therefore, the test item HEMATOXYLIN HPL (CAS 517-28-2) is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing (in vitro and/or in vivo) are required to establish a definitive classification.
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