Registration Dossier
Registration Dossier
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EC number: 213-022-2 | CAS number: 915-67-3
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:
- other: data from peer - reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- 402. Amaranth (WHO Food Additives Series 8)
- Author:
- Joint FAO/WHO Expert Committee on Food Additives which met in Geneva, 14‐23 April 1975
- Year:
- 1 975
- Bibliographic source:
- WHO FOOD ADDITIVES SERIES NO. 8, 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- to assess the skin sensitizing potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate
- EC Number:
- 213-022-2
- EC Name:
- Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 915-67-3
- Molecular formula:
- C20H14N2O10S3.3Na
- IUPAC Name:
- trisodium 3-hydroxy-4-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-2,7-disulfonate
- Reference substance name:
- trisodium (4E)-3-oxo-4-[(4- sulfonato-1- naphthyl)hydrazono]naphthalene- 2,7-disulfonate
- IUPAC Name:
- trisodium (4E)-3-oxo-4-[(4- sulfonato-1- naphthyl)hydrazono]naphthalene- 2,7-disulfonate
- Reference substance name:
- Amaranth dye
- IUPAC Name:
- Amaranth dye
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of test material (as cited in study report): Amaranth dye
Molecular formula (if other than submission substance): C20H11N2Na3O10S3
Molecular weight (if other than submission substance): 604.47
Smiles notation (if other than submission substance): c1ccc2c(c1)c(ccc2S(=O)(=O)[O])N=Nc3c4ccc(cc4cc(c3O)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChl (if other than submission substance): 1S/C20H14N2O10S3.3Na/c23-20-18(35(30,31)32)10-11-9-12(33(24,25)26)5-6-13(11)19(20)22-21-16-7-8-17(34(27,28)29)15-4-2-1-3-14(15)16;;;/h1-10,23H,(H,24,25,26)(H,27,28,29)(H,30,31,32);;;/q;3*+1/p-3
Substance type: Organic
Physical state: Solid
Constituent 1
Constituent 2
Constituent 3
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)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- no data
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- no data
- 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
In vivo (non-LLNA)
Results
- Reading:
- other: mean
- Group:
- test chemical
- Dose level:
- no data
- No. with + reactions:
- 0
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: other: mean. Group: test group. Dose level: no data. No with. + reactions: 0.0. Clinical observations: no data.
Any other information on results incl. tables
Not Specified
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- In experiments with guinea-pigs, it was found that Amaranth had no sensitization activity
- Executive summary:
In experiments with guinea‐pigs, it was found that Amaranth had no sensitization activity
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