Registration Dossier
Registration Dossier
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EC number: 825-571-0 | CAS number: 60428-79-7
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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer
- EC Number:
- 825-571-0
- Cas Number:
- 60428-79-7
- Molecular formula:
- C18H36Mo2N2O2S6
- IUPAC Name:
- Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer
- Test material form:
- solid: particulate/powder
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): approx. 60 mg - Duration of treatment / exposure:
- 6 hours ± 15 minutes
- Duration of post- treatment incubation (in vitro):
- 18 hours ± 15 minutes
- Number of animals or in vitro replicates:
- 2 tissues
- Details on study design:
- see attached documents "S-600 - Eye irritation (EpiOcular) Study Design.pdf"
Results and discussion
In vitro
Results
- Irritation parameter:
- other: mean tissue viability (& of control)
- Value:
- 104
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
for detailed results see attached document "S-600 - Eye irritation (EpiOcular) Results.pdf"
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since the mean relative tissue viability for S-600 was above 60% S-600 is considered to be non-irritant, i.e. no classification according to REGULATION (EC) 1272/2008.
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