Registration Dossier
Registration Dossier
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EC number: 240-006-2 | CAS number: 15876-40-1
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)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- REPORTS of the Scientific Committee on Cosmetology (seventh series)
- Author:
- European Commission (EC) - Scientific Committee on Cosmetology (SCC)
- Year:
- 1 988
- Bibliographic source:
- COMMISSION OF THE EUROPEAN COMMUNITIES; Brussels, Luxembourg, 1988.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Kligman maximisation test was conducted to the skin of 25 human subjects to determine the sensitization potential of chemical FD and C Red 4 (CAS No.4548-53-2).
- GLP compliance:
- not specified
- Type of study:
- other: Kligman maximisation test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
- EC Number:
- 224-909-9
- EC Name:
- Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
- Cas Number:
- 4548-53-2
- Molecular formula:
- C18H16N2O7S2.2Na
- IUPAC Name:
- disodium 3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):FD&C Red No. 4
- Molecular formula :C18H14N2O7S2.2Na
- Molecular weight :480.4276 g/mol
- Substance type:Organic
- Physical state:Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):FD&C Red No. 4
- Molecular formula :C18H14N2O7S2.2Na
- Molecular weight :480.4276 g/mol
- Substance type:Organic
- Physical state:Solid
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: no data available
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.3%(300 mg)
- Day(s)/duration:
- 48hr
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.3%(300gm)
- Day(s)/duration:
- 48hr
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 25
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3%(300gm)
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Clinical observations:
- No skin sensitization reaction observed
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- Non-sensitizing effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test material FD and C red 4 (CAS No.4548-53-2) was considered to be not sensitizing to the skin of human subjects in Kligman maximization test.
- Executive summary:
Kligman maximisation test was conducted onto the skin of 25 human subjects to determine the sensitization potential of chemical FD and C Red 4 (CAS No.4548-53-2).
Each subjects were exposed to the FD and C red 4 atconcentration of 0.3% (0.3 gm) in petrolatum and applied under occlusion for 48-hrs.
Since none of the subject showed skin sensitizing effects, the chemicalFD and C red 4(CAS No.4548-53-2)was considered to be not sensitizing to the skin of human subjects.
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