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Toxicological information

Skin sensitisation

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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:
1975
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

Constituent 1
Chemical structure
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
Constituent 2
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
Constituent 3
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

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