Registration Dossier
Registration Dossier
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EC number: 208-013-5 | CAS number: 505-54-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- eye corrosion in vitro
- 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
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hexadecanedioic acid
- EC Number:
- 208-013-5
- EC Name:
- Hexadecanedioic acid
- Cas Number:
- 505-54-4
- Molecular formula:
- C16H30O4
- IUPAC Name:
- hexadecanedioic acid
Constituent 1
Test animals / tissue source
- Species:
- chicken
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg
- Duration of treatment / exposure:
- 10 seconds
- Number of animals or in vitro replicates:
- 3 enucleated chicken eyes
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- ca. 0.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- mean
- Value:
- ca. 1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- mean
- Value:
- ca. 8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.7, corresponding to ICE class II;
- mean score of fluorescein retention: 1.0, corresponding to ICE class II;
- maximal mean corneal swelling: 8%, corresponding to ICE class II.
The combination of the three endpoints for the test HEXADECANEDIOIC ACID was 3 x II.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- 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 HEXADECANEDIOIC ACID 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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