Registration Dossier
Registration Dossier
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EC number: 231-274-1 | CAS number: 7474-78-4
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:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Chorioallantoic Membrane Assay
- Principles of method if other than guideline:
- available in study report
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,4-diaminobenzenesulphonic acid
- EC Number:
- 231-274-1
- EC Name:
- 3,4-diaminobenzenesulphonic acid
- Cas Number:
- 7474-78-4
- Molecular formula:
- C6H8N2O3S
- IUPAC Name:
- 3,4-diaminobenzene-1-sulfonic acid
- Details on test material:
- - Name of test material (as cited in study report): Orthaminsäure
- Physical state: solid
- Analytical purity: 99.1%
- Impurities (identity and concentrations): see 1.4
- Composition of test material, percentage of components: see 1.4
- Purity test date: 15.09.2011
- Lot/batch No.: N-18326
- Expiration date of the lot/batch: 15.09.2013
Constituent 1
Test animals / tissue source
- Species:
- other: Chicken Eggs
- Strain:
- other: White Leghorn
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1 - 6
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- According to the evaluation criteria the test item is classified as non irritating to mucous membranes. Under the conditions of the present study, it can be stated that no irritation can be expected if the test item comes in contact with eyes.
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