Registration Dossier
Registration Dossier
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EC number: 227-458-6 | CAS number: 5850-86-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- other: experimental result on similar substance
- Adequacy of study:
- key study
- 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:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
- EC Number:
- 211-199-0
- EC Name:
- Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
- Cas Number:
- 633-96-5
- Molecular formula:
- C16H12N2O4S.Na
- IUPAC Name:
- Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: mixture ethanol/water (50/50)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 28.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic symptoms were observed..
- Parameter:
- SI
- Remarks on result:
- other: 2.5%: 1.10 5%: 1.10 10%: 1.59
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Per Node: Negative control: 43.43 2.5%: 47.90 5%: 47.88 10%: 69.20 Per group: Negative control: 347.47 2.5%: 383.17 5%: 383.04 10%: 553.59
Any other information on results incl. tables
No clinical signs, no mortality and no noteworthy increase in ear thickness were observed during the study.
Conceming the lymphoproliferative response, the incorporation of tritiated methyl thymidine in the treated groups was similar to that ofthe vehicle control group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- According to EEC (European Economie Community) and CLP classification the tested substance Acid Orange 7 is not a skin sensitizer.
- Executive summary:
The purpose of this skin sensitization study was to assess the allergenic potential of similar substance 01 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.
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