Registration Dossier
Registration Dossier
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EC number: 231-274-1 | CAS number: 7474-78-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: New Guideline Study under GLP-Conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0.1, 0.3 and 0.75 %
- No. of animals per dose:
- 5
- Positive control substance(s):
- other: p-Phenylenediamine (CAS 106-50-3)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- 0.1 %
- Value:
- 0.6
- Test group / Remarks:
- 5 female
- Parameter:
- SI
- Remarks:
- 0.3 %
- Value:
- 0.9
- Test group / Remarks:
- 5 female
- Parameter:
- SI
- Remarks:
- 0.75 %
- Value:
- 1.3
- Test group / Remarks:
- 5 female
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3. Consequently, according to OECD 429 the test item 3,4-Diaminobenzenesulfonic acid as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser. According to EU 286/2011 as well as GHS the test item has no obligatory labbelling requirement for skin sensitation and is unclassified.
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