Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 274-352-0 | CAS number: 70161-16-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- 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 peer rerviewed journal and authoritative database
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- WHO Food Additives
- Author:
- Joint FAO/WHO Expert Committee on Food Additives
- Year:
- 1 980
- Bibliographic source:
- Joint FAO/WHO Expert Committee on Food Additives, 2004
- Reference Type:
- other: Authoritative data base
- Title:
- HSDB (Hazardous Substances Data Bank)
- Author:
- U.S National Library of Medicine
- Year:
- 2 011
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank), U.S National Library of Medicine ; 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To evaluate skin sensitization potential of the test chemical on 200 human subjects
- GLP compliance:
- not specified
- Type of study:
- other: Draize-Shelanski repeated insult 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:
- - Name of test material (as cited in study report): disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC)- Substance type: Organic- Physical state: solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Not specified
- Day(s)/duration:
- 10 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Not specified
- Day(s)/duration:
- 24 hrs
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 200 human subjects
- Details on study design:
- MAIN STUDY A. INDUCTION EXPOSUREExposure period: 24 hrs - Test groups: 200 human subject - Control group: no data - Site: volvar forearms - Duration: 10 days - Concentrations: no data B. CHALLENGE EXPOSURE - No. of exposures: no data - Day(s) of challenge: 24 hrs - Exposure period: 24 hrs - Test groups: 200 human subjects - Control group: no data - Site: scapular backs - Concentrations: no data - Evaluation (hr after challenge): 24 hrs OTHER: challenge treatment was given 14 days after induction
- 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:
- Not specified
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- No positive skin allergic skings were observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical did not produce any skin allergic reaction in the induction as well as challenge treatment. Hence, the test chemical was considered to be not sensitizing to skin .
- Executive summary:
Draize- Shelanski Repeat Insult Patch Test was performed on 200 human subjects to determine the degree of dermal sensitization caused by the test chemical.
The test chemical was applied to the subject's volvar forearms as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge treatment were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The test chemical did not produce any skin allergic reaction in the induction as well as challenge treatment.
Hence, the test chemical was considered to be not sensitizing to skin .
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
