Registration Dossier
Registration Dossier
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EC number: 224-924-0 | CAS number: 4553-89-3
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 The International Programme on Chemical Safety (IPCS)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- AZORUBINE
- Author:
- The International Programme on Chemical Safety (IPCS)
- Year:
- 2 015
- Bibliographic source:
- Azorubine (WHO Food Additives Series 18), 06-15-15
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Skin sensitization potential of the substance of Azorubine (Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate) in guinea pigs.
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate
- EC Number:
- 222-657-4
- EC Name:
- Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate
- Cas Number:
- 3567-69-9
- Molecular formula:
- C20H14N2O7S2.2Na
- IUPAC Name:
- disodium 4-hydroxy-3-[(E)-2-(4-sulfonatonaphthalen-1-yl)diazen-1-yl]naphthalene-1-sulfonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- No data
- Details on study design:
- No data
- Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- No clinical symptoms observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance Azorubine (Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate) was determined to be non-sensitising to skin of guinea-pigs.
- Executive summary:
The skin irritation effect of Azorubine (Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate) was tested in guinea-pigs. Azorubine was determined to be non-sensitising to skin of guinea pigs.
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