Registration Dossier
Registration Dossier
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EC number: 256-380-5 | CAS number: 49564-57-0
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: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-amino-5-methoxy-N,2-dimethylbenzenesulphonamide
- EC Number:
- 256-380-5
- EC Name:
- 4-amino-5-methoxy-N,2-dimethylbenzenesulphonamide
- Cas Number:
- 49564-57-0
- Molecular formula:
- C9H14N2O3S
- IUPAC Name:
- 4-amino-5-methoxy-N,2-dimethylbenzene-1-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): Kresidinsulfmethylamide TF
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 18.4 - 22.2 gr
- Housing: single, macrolone cage
- Diet: pelleted standard diet (Harlan Winkelmann GmbH) ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 30 - 72
- Photoperiod: 12 hrs dark /12 hrs light):
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 1.5, 3, 6 %
- No. of animals per dose:
- 5
- Details on study design:
- Administration and exposure: In RCC-CCR Study 1104502 (non-GLP) 6% of the test item was demonstrated to be the highest concentration not inducing systemic toxicity. In this study at a concentration of 12.5 % two of four animals died after treatment with the test item. The top dose of the test item (6%) is the highest technically achievable concentration whilst avoiding systemic toxicity and excessive local irritation.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- EC3 = (a-c) [(3-d)/(b-d)] + c
Results and discussion
- Positive control results:
- EC3: 6.7% (w/v)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration: 0.0 % (w/v) / number of lymph nodes: 10 / DPM per lymph node: 634.7 / Stimulation index: 1.0 Concentration: 1.5 % (w/v) / number of lymph nodes: 10 / DPM per lymph node: 679.5 / Stimulation index: 1.1 Concentration: 3.0 % (w/v) / number of lymph nodes: 10 / DPM per lymph node: 708.5 / Stimulation index: 1.1 Concentration: 6.0 % (w/v) / number of lymph nodes: 10 / DPM per lymph node: 678.5 / Stimulation index: 1.1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Concentration: 0.0 % (w/v) / number of lymph nodes: 10 / DPM per lymph node: 634.7 / Stimulation index: 1.0 Concentration: 1.5 % (w/v) / number of lymph nodes: 10 / DPM per lymph node: 679.5 / Stimulation index: 1.1 Concentration: 3.0 % (w/v) / number of lymph nodes: 10 / DPM per lymph node: 708.5 / Stimulation index: 1.1 Concentration: 6.0 % (w/v) / number of lymph nodes: 10 / DPM per lymph node: 678.5 / Stimulation index: 1.1
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item was not a skin sensitizer in this assay.
- Executive summary:
- In the study the test item Kresidinsulfmethylamide TF dissolved in
dimethyl sulfoxide was assessed for its possible contact allergenic
potential.
For this purpose a local lymph node assay according to OECD 429 was performed using test item concentrations of 1.5, 3, and 6%. Higher concentration could not be applied due to toxic effects (lethality) determined with 12.5 % of the substance.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 1.1, 1.1, and 1.1 were determined with the test item at concentrations of 1.5, 3, and 6% in dimethyl sulfoxide, respectively.
The test item Kresidinsulfmethylamide TF was not a skin sensitiser in this assay.
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