Registration Dossier
Registration Dossier
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EC number: 214-882-1 | CAS number: 1205-30-7
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
- Report date:
- 2018
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)
- Version / remarks:
- 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 - Deviations:
- yes
- Remarks:
- Due to a failure to meet the assay acceptance criteria of the negative controls (opacity scores to high), it was necessary to repeat the test. Therefore the test performed on 11th January 2018 will not be reported and disregarded. Due to the Labtech LT-45
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-chloro-5-sulphamoylbenzoic acid
- EC Number:
- 214-882-1
- EC Name:
- 4-chloro-5-sulphamoylbenzoic acid
- Cas Number:
- 1205-30-7
- Molecular formula:
- C7H6O4NClS
- IUPAC Name:
- 4-chloro-3-sulfamoylbenzoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- cattle
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 4.2
- 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.
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