Registration Dossier
Registration Dossier
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EC number: 231-274-1 | CAS number: 7474-78-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- other: Guideline study under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 439
- Qualifier:
- according to guideline
- Guideline:
- other: EU B.43
- Guideline:
- other: L'oréal Standard Operating Procedure: Episkin TM skin irritation test method
- 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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 mg/tissue
- Duration of treatment / exposure:
- 15 h
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 95.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 99.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 97.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The relative mean tissue viability after 15 min of exposure and 42 h post incubation was >50%. The test item is therefore classified as "non irritant"
according to UN GHS and EU CLP "no catagory".
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