Registration Dossier
Registration Dossier
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EC number: 617-393-5 | CAS number: 82834-12-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 june 2017
- Reliability:
- 1 (reliable without restriction)
- 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 Opac
ity and Permeability Assay”
• Method B.47 of Commission Regulation (EC) No. 440/2008
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2S)-2-[[(2S)-1-ethoxy-1-oxopentan-2-yl]amino]propanoic acid
- EC Number:
- 617-393-5
- Cas Number:
- 82834-12-6
- Molecular formula:
- C10 H19 N O4
- IUPAC Name:
- (2S)-2-[[(2S)-1-ethoxy-1-oxopentan-2-yl]amino]propanoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- White powder
Constituent 1
- Specific details on test material used for the study:
- Batch: 18128093
Purity: 100.5%
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Test System: Freshly isolated bovine cornea (at least 9 month old donor cattle)
Rationale: OECD 437
Source: AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany
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. 0.53
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, CARBANINE CRIST is not categorized (GHS).
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