Registration Dossier
Registration Dossier
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EC number: 226-952-9 | CAS number: 5577-13-9
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)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl [(4-methylphenyl)sulphonyl]carbamate
- EC Number:
- 226-952-9
- EC Name:
- Ethyl [(4-methylphenyl)sulphonyl]carbamate
- Cas Number:
- 5577-13-9
- Molecular formula:
- C10H13NO4S
- IUPAC Name:
- ethyl [(4-methylphenyl)sulfonyl]carbamate
- Test material form:
- other: In vitro
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine corneal
Test system
- Vehicle:
- physiological saline
- Remarks:
- 20% Imidazole
- Controls:
- other: Yes: There were positive and negative control in this study.
- Amount / concentration applied:
- 305 to 307mg was added pure on top of the corneas
- Duration of treatment / exposure:
- 4 hours.
- Number of animals or in vitro replicates:
- No animals in this test but 3 in vitro bovine cornea samples.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Tolfamato
- Value:
- ca. 94
- Negative controls validity:
- valid
- Remarks:
- Mean In vitro Irritation Score Negative control -1.0
- Positive controls validity:
- valid
- Remarks:
- Mean In vitro Irritation Score Positive control 113
- Remarks on result:
- other: Data shown are Mean IVIS taken into account: 1) Calculated using the negative control mean opacity and mean permeability values. 2) In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Any other information on results incl. tables
The corneas trated with the positive control were turbid after the 240 minutes of treatment.
Corneas treated showed opacitiy values ranging from 74 to 106 and permeability values ranging from -0,021 to 0,064.
Irritancy score was 94 after 240 minutes of treatment with Tolfamato. The induced irritation was mainly observed at one endpoint.Since Tolfamato induced an IVIS>55,1. It is concluded that tolfamato is corrosive or severe irritante in the Bovine corneal Opacity and Permeability Test under the experimental conditions described in this report.
Applicant's summary and conclusion
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