Registration Dossier
Registration Dossier
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EC number: 485-290-0 | CAS number: 3021-02-1
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 485-290-0
- EC Name:
- -
- Cas Number:
- 3021-02-1
- Molecular formula:
- C2H8N10
- IUPAC Name:
- 5-(1H-1,2,3,4-tetrazol-5-yl)-1H-1,2,3,4-tetrazole diamine
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/water 70/30
- Concentration:
- 5 % , 10 %, 20 %
- No. of animals per dose:
- 4
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Indices of 0.64, 1.23 and 1.10 were determined with the test item at concentrations of 5, 10, and 20% in ethanol:deionised water (70+30).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Test item concentration % (w/v) Group Measurement DPM Calculation conc. DPM-BGa) number of lymph nodes DPM per lymph nodeb) 0 BG I 20 --- --- --- 0 BG II 23 --- --- --- 0 1 3727 3706 8 463.2 5 2 2395 2374 8 296.7 10 3 4576 4555 8 569.3 20 4 4108 4087 8 510.8
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information not classified
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