Registration Dossier
Registration Dossier
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EC number: 217-699-5 | CAS number: 1934-21-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- EC Number:
- 217-699-5
- EC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Cas Number:
- 1934-21-0
- Molecular formula:
- C16H12N4O9S2.3Na
- IUPAC Name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Test material form:
- solid: particulate/powder
- Details on test material:
- No data
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 1; 2,5 and 5%
- No. of animals per dose:
- 4 females per group
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 1.48
- Test group / Remarks:
- 1% : 1,48
- Parameter:
- SI
- Value:
- 1.46
- Test group / Remarks:
- 2,5%: 1.46
- Parameter:
- SI
- Value:
- 2.16
- Test group / Remarks:
- 5 %: 2.16
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Per group: Vehicle: 309.20 1%: 458.7 2,5%: 450.02 5%: 667.02 Per node: Vehicle: 38.65 1%: 57.34 2,5%: 56.25 5%: 83.38
Any other information on results incl. tables
No clinical signs, no mortality and no noteworthy increase in ear thickness were observed during the study.
Concerning the lymphoproliferative response, no positive lymphoproliferative response (SI > 3) and no dose-response relationship were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to EEC (European Economie Community) and CLP classification the tested substance Acid yellow 23 is not a skin sensitizer.
- Executive summary:
The purpose of this skin sensitization study was to assess the allergenic potential of Acid Yellow 23 when administered to the skin of CBA mice following OECD 429, murine local lymph assay.
Based on the results, the tested item should not be considered as skin sensitizer under defined experimental conditions in the two vehicles tested.
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