Registration Dossier
Registration Dossier
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EC number: 209-481-3 | CAS number: 582-25-2
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
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium benzoate
- EC Number:
- 209-481-3
- EC Name:
- Potassium benzoate
- Cas Number:
- 582-25-2
- Molecular formula:
- C7H6O2.K
- IUPAC Name:
- potassium benzoate
Constituent 1
Test system
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- ca. 2.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of the test system, Potassium benzoate is considered as eye irritant in the EpiOcularTM Eye Irritation Test.
After treatment with the test item, the relative absorbance values were reduced to 2.5 %.
This value is below the threshold for eye irritation potential (≤ 60%).
All validity criteria were met. The criterion for optical density of the negative control was fulfilled
The positive control induced a decrease in the relative absorbance as compared to the negative control to 39%. - Executive summary:
Note the viability score of 2.5 is almost identical to that of lithium benzoate (2.6) and this was concluded to be Eye Dam 1 as a result of an subsequent BCOP study
For this reason, it is proposed to classify potassium benzoate as Eye Dam 1.
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