Registration Dossier
Registration Dossier
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EC number: 273-381-6 | CAS number: 68958-92-9
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 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)
- Version / remarks:
- October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum
- EC Number:
- 273-381-6
- EC Name:
- Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum
- Cas Number:
- 68958-92-9
- Molecular formula:
- C32H68Mo2O6P2S6
- IUPAC Name:
- Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- human
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 10 ± 1 minutes
- Duration of post- treatment incubation (in vitro):
- 120 ± 10 minutes
- Number of animals or in vitro replicates:
- 3 corneas
- Details on study design:
- see attached documents "S-930 - Eye irritation (BCOP) Study Design.pdf"
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Value:
- 5.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no prediction can be made
- Irritation parameter:
- cornea opacity score
- Value:
- 2.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein leakage
- Value:
- 0.206
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Since S-930 induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.
Any other information on results incl. tables
for detailed results see attached document "S-930 - Eye irritation (BCOP) Results.pdf"
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Since S-930 induced an IVIS > 3 ≤ 55, the study cannot be used for classification. An EpiOcular™ Cornea Epithelial Model assay was performed.
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