Registration Dossier
Registration Dossier
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EC number: 617-898-0 | CAS number: 866462-52-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was performed in compliance with the following regulations or guidelines:
• OECD Guideline for the Testing of Chemicals No. 437 (updated 26 July 2013) “Bovine Corneal Opacity and Permeability Assay”
• Method B.47 of Commission Regulation (EC) No. 440/2008
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 617-898-0
- EC Number:
- 617-898-0
- Cas Number:
- 866462-52-4
- Molecular formula:
- C17 H21 N O5
- IUPAC Name:
- 617-898-0
- Test material form:
- solid: particulate/powder
- Details on test material:
- Off white powder
Constituent 1
- Specific details on test material used for the study:
- Batch 18108859
Test animals / tissue source
- Species:
- cattle
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 0.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No category. Not requiring classification to UN GHS or EU CLP .
- Executive summary:
No category. Not requiring classification to UN GHS or EU CLP .
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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