Registration Dossier
Registration Dossier
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EC number: 610-522-6 | CAS number: 503155-49-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from handbook or collection of data.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Skin sensitization potential of test chemical.
- Author:
- WHO
- Year:
- 1 981
- Bibliographic source:
- WHO, 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human maximization test
- Principles of method if other than guideline:
- Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- -IUPAC name :Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate-Common name-1-(2-methoxy-5-methyl-4-sulfophenyl-1-azo)-6 sulfo-2-hydroxynapthalene, disodium salt ( ALLURA RED AC)-Molecular formula:C18H16N2O8S2.2Na-Molecular weight:496.4266 g/mol- Substance type: Organic- Physical state: solid-InChI:1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;Smiles:c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N=N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O.[Na+].[Na+]
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Aqueous solution
- Concentration / amount:
- No data available
- Day(s)/duration:
- 24 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqueous solution
- Concentration / amount:
- 24 hours
- Day(s)/duration:
- No data available
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 200 subjects
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period:24 hours
- Test groups: 200 subjects
- Control group: no data
- Site: volvar forearms
- Frequency of applications:
- Duration: 10 alternate days
- Concentrations: no data
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 14 days
- Exposure period: 24 hours
- Test groups: 200 subjects
- Control group:
- Site: scapular backs
- Concentrations: no data
- Evaluation (hr after challenge): after 24 hours - Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- No data available
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- None of the subjects showed any signs of contact sensitization.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period. Therefore the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.
- Executive summary:
Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical .In this study, the chemical applied to the subject’s volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period. Therefore the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.
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