Registration Dossier
Registration Dossier
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EC number: 220-491-7 | CAS number: 2783-94-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Magnusson & Kligman Maximization Study in the Guinea Pig;
- Author:
- R.L. Guest,
- Year:
- 1 989
- Bibliographic source:
- Safepharm Project No. 140/80R; Test Report, Derby; DE1 2BT; U.K; 1989
- Reference Type:
- publication
- Title:
- OPINION ON Acid Orange 7
- Author:
- European Commission
- Year:
- 2 011
- Bibliographic source:
- Scientific Committee on Consumer Safety SCCS OPINION ON Acid Orange 7 COLIPA n° C15;22 March 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- other: Magnusson & Kligman Maximisation test
- Justification for non-LLNA method:
- The available non LLNA data is sufficent for deciding the classification of the substance.
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)diazenyl]benzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report):Acid Orange 7
- Substance type:organic
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: liquid paraffin
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- other: liquid paraffin
- No. of animals per dose:
- 20 females in test group, 10 females in control group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 20 females in test group
- Control group: 10 females in control group
- Site: intradermal
- Duration:25 days
- Frequency of applications: daily
- Concentrations: 25% in liquid paraffin, 25% dilution of the test item in FCA plus liquid paraffin; ratio 1:1. One week later, the epidermal induction of sensitization was conducted under occlusion with the test item at 50% in paraffin for 48 hours.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Site: Cutaneous
- Concentrations: 10% and 5% in liquid paraffin
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: induction
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- By epidermal induction under occlusion with the test item at 50% in paraffin for 48 hours no any sensitization effects was observed.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: induction. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 30.0. Clinical observations: By epidermal induction under occlusion with the test item at 50% in paraffin for 48 hours no any sensitization effects was observed..
- Reading:
- other: challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- No any cutaneous reactions were evaluated at 24 and 48 hours of observation.
- Remarks on result:
- other: Reading: other: challenge. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 30.0. Clinical observations: No any cutaneous reactions were evaluated at 24 and 48 hours of observation..
Any other information on results incl. tables
not sensitising
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After challenge no skin reactions were observed. Therefore, based on the result in this adjuvant test in guinea pigs the test article Acid Orange 7 was considered as a non-sensitizer.
- Executive summary:
After challenge no skin reactions were observed. Therefore, based on the result in this adjuvant test in guinea pigs the test article Acid Orange 7 was considered as a non-sensitizer.
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