Registration Dossier
Registration Dossier
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EC number: 235-437-8 | CAS number: 12227-62-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 16185:1.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: 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 from peer- reviewed journals
Data source
Referenceopen allclose all
- Reference Type:
- other: Authoritative data base
- Title:
- Skin Irritation in rabbits
- Author:
- U S National Library of Medicine
- Year:
- 2 012
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC
- Reference Type:
- publication
- Title:
- 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:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the skin irritation potential of Amaranth in rabbits
- GLP compliance:
- 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 (4E)-3-oxo-4-[2-(4-sulfonatonaphthalen-1-yl)hydrazin-1-ylidene]-3,4-dihydronaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name of test material (as cited in study report): Amaranth dye
Molecular formula : C20H11N2Na3O10S3
Molecular weight : 604.47g/mol
Smiles notation : c1ccc2c(c1)c(ccc2S(=O)(=O)[O])N=Nc3c4ccc(cc4cc(c3O)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChl : 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
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Amaranth dye
Molecular formula : C20H11N2Na3O10S3
Molecular weight : 604.47g/mol
Smiles notation : c1ccc2c(c1)c(ccc2S(=O)(=O)[O])N=Nc3c4ccc(cc4cc(c3O)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChl : 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
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: Distilled water or ointment
- Controls:
- not specified
- Amount / concentration applied:
- 0.1% X 1% dye in ointment or water vehicle
- Duration of treatment / exposure:
- no data
- Observation period:
- no data
- Number of animals:
- Six groups of rabbits
- Details on study design:
- no data
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data available
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No significant dermal or systemic toxicity related to treatment was seen.
- Other effects:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- In a Primary Skin Irritation Test in rabbits with 0.1% X 1% of Amaranth in distilled water or ointment, no irritation or significant dermal [systemic] toxicity was observed.
Hence, Amaranth can be considered to be not irritating to skin. - Executive summary:
A study was performed to determine the dermal irritation and percutaneous toxicity of Amaranth dye in rabbits.
0.1% X 1% of Amaranth in distilled water or ointment was applied to the skin of six groups of nine rabbits and observed for signs of irritation(duration not specified).
No irritation or significant dermal [systemic] toxicity was observed.
Hence, Amaranth can be considered to be not irritating to skin.
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