Registration Dossier
Registration Dossier
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EC number: 626-424-1 | CAS number: 59572-10-0
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:
- 2 019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.1000
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3,6,8-Pyrenetetrasulfonic acid, sodium salt (1:4)
- EC Number:
- 626-424-1
- Cas Number:
- 59572-10-0
- Molecular formula:
- C16H16O12S4.4Na
- IUPAC Name:
- 1,3,6,8-Pyrenetetrasulfonic acid, sodium salt (1:4)
Constituent 1
Test animals / tissue source
- Species:
- cattle
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- 90 minutes
- Number of animals or in vitro replicates:
- Nine corneas
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test Substance (PTSA)
- Value:
- 7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the results of this study, PTSA meets the requirements of EPA Category III and UN GHS No prediction can be made for the BCOP test.
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