Registration Dossier
Registration Dossier
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EC number: 233-465-5 | CAS number: 10191-18-1
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:
- 2 017
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid
- EC Number:
- 233-465-5
- EC Name:
- 2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid
- Cas Number:
- 10191-18-1
- Molecular formula:
- C6H15NO5S
- IUPAC Name:
- 2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): I850
- Substance type: White crystalline powder
- Composition of test material, percentage of components: 99.1%
- Lot/batch No.: 7604
- Storage condition of test material: Ambient
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The EpiOcularTM tissue model (OCL-200-MatTek Corporation) is composed of stratified human keratinocytes in a three-dimensional structure, reflecting the morphology and function of the human corneal epithelium found in vivo.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Percentage of viability
- Value:
- ca. 81
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The viability of the test result is 81% and it is higher then the classification criteria, viability < 60%. Therefore, the test substance is not classified for eye irritation.
- Executive summary:
In this study, the eye irritation potential of 2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid (CAS 10191-18-1, EC 233-465-5) was assessedin vitroaccording to OECD Test 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).
After 6h ± 15 mins’ exposure on the surface of EpiOcularTMreconstructed ocular epithelium and 18h ± 15 mins post-incubation time, the viability of the tissues was assessed and compared to a negative control. The percentage viability obtained was 81.068 % and therefore:2 -[bis(2-hydroxyethyl)amino]ethanesulphonic acid (CAS 10191-18-1, EC 233-465-5) was classified as non-Irritant to the human eye.
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