Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 243-717-6 | CAS number: 20298-05-9
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 from peer reveiwed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- An animal model assessment of common dye-induced allergic contact dermatitis
- Author:
- JOE DINARDO, RaleighN, C; and ZOE DIANA DRAELOS
- Year:
- 2 007
- Bibliographic source:
- JOURNAL OF COSMETIC SCIENCE, 58, 209-214 May/June 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: modified Buehler and the Klecak method
- Principles of method if other than guideline:
- A modified Buehler and Klecak method for open epicutaneous testing[OET] was performed to assess the sensitization potential of Tartrazine
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- EC Number:
- 217-699-5
- EC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Cas Number:
- 1934-21-0
- Molecular formula:
- C16-H12-N4-O9-S2.3Na
- IUPAC Name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Test material form:
- solid
- Details on test material:
- - Name of test material (IUPAC name): trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Common name: Acid Yellow 23,Tartrazine
- Molecular formula: C16H9N4Na3O9S2
- Molecular weight:534.3681 g/mol
- Smiles notation: n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
-InChl:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;;
- Substance type: Organic
- Physical state:Soild
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (IUPAC name): trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Common name: Acid Yellow 23,Tartrazine
- Molecular formula: C16H9N4Na3O9S2
- Molecular weight:534.3681 g/mol
- Smiles notation: n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
-InChl:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;;
- Substance type: Organic
- Physical state:Soild
In vivo test system
Test animals
- Species:
- guinea pig
- 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, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 ml of test chemical
- Day(s)/duration:
- 3 times weekly(Monday, Wednesday , Friday)
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 ml of test chemical
- Day(s)/duration:
- 24-hrs
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 1,0.5,0.25%
- Adequacy of challenge:
- other: rechallenge for positive reaction at 10% in challenge exposure
- No. of animals per dose:
- 10 albino guinea pigs
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3 times weekly(Monday, Wednesday , Friday)
- Exposure period:3 weeks
- Test groups:Yes
- Control group:No
- Site:Left flank shaved albino guinea pigs
- Frequency of applications:3 times weekly
- Duration:3 weeks
- Concentrations:0.1 ml of tartrazine
B. CHALLENGE EXPOSURE
- No. of exposures:Once
- Day(s) of challenge:After 2 weeks of rest period from induction exposure
- Exposure period:No data available
- Test groups:Yes
- Control group:No
- Site:Right flank of shaved guinea pig
- Concentrations:10,5 and 2.5 % of the induction concentration
- Evaluation (hr after challenge):24-hrs
C: Rechallenge
- Concentrations: 0.25,0.5 and 1% of the induction concentration
OTHER: All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale
0 = no reaction,
1 -- slight reaction,
2 = moderate reaction,
3 = severe reaction - Challenge controls:
- no data available
- Positive control substance(s):
- yes
- Remarks:
- 0.5% of 2,4-dinitrochlorobenzene (DNCB) in ethanol was included for both the induction and challenge phases
Results and discussion
- Positive control results:
- The positive control DNCB at the 0.5% induction/challenge concentration elicited positive responses in all animals tested
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5% in propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: challenge group
- Dose level:
- 5% in propylene glycol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- signs of dermal sensitization were observed
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 1.0,0.5,0.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no dermal reactions observations
- Remarks on result:
- other: at 1% concentration only 1 guinea pig showed some signs of dermal sensitization, but no dermal reactions were observed at 0.5,0.25%
Any other information on results incl. tables
Table 1: Allergic contact dermatitis of dyes
Name of the dye |
Color Index |
Chemical class |
Induction concentration in propylene glycol |
Challenge concentration in propylene glycol* |
||
10% |
5% |
2.5% |
||||
Tartrazine |
19140 |
Monoazo |
10% |
+(20%) |
Negative |
Negative |
Table 2: Dose-response of dyes eliciting positive response at 10% concentration
Name of the dye |
Color Index |
Chemical class |
Induction concentration in propylene glycol |
Challenge concentration in propylene glycol* |
||
1% |
0.5% |
0.25% |
||||
Tartrazine |
19140 |
Monoazo |
1% |
+(10%) |
Negative |
Negative |
*results expressed as negative or positive (+) with percent of animals in the group demonstrating an allergic reaction in parenthesis
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Tartazine produced a positive reaction at 10% challenge exposure, but in the retest no reactions were observed at 1%,0.5 and 0.25% challenge concentrations.
Hence, it was considered that Tartrazine doesnot induce any sensitization in guinea pigs when tested below 10% concentration. - Executive summary:
A modified Buehler and Klecak method for open epicutaneous testing[OET] was performed to assess the sensitization potential of Tartrazine.
Tartrazine was tested at an induction concentration of 10% and challenge concentrations of 10.0%, 5.0%, and 2 .5%.
For the induction phase, the left flanks of ten albino guinea pigs were shaved and the dye test material applied three times weekly (Monday, Wednesday, Friday) for three consecutive weeks. Each animal received 0.1 ml of the dye test material over a 1.8-cm circular area. Following the induction period, the guinea pigs entered the challenge phase. The challenge phase began after a two-week rest period when the right flank of each guinea pig was shaved and exposed to three different dye test material concentrations(10.0%, 5.0%, and 2 .5%). Twenty-four hours after the last induction and challenge application, the animals were depilated to clearly observe dermal reactions.
All test sites were graded for erythema and edema 24 and 48 hours post-application using a four-point ordinal scale.A positive control of 0.5% 2,4-dinitrochlorobenzene(DNCB) in ethanol was included for both the induction and challenge phases.
Since a positive response was observed in the challenge exposure at 10% challenge exposure, Tartrazine was retested using a 1% induction exposure and challenge concentrations of 1.0%, 0.5%, and 0.25%.
Tartazine produced a positive reaction at 10% challenge exposure, but in the retest no reactions were observed at 1%, 0.5 and 0.25% challenge concentrations.
Hence, it was considered that Tartrazine does not induce any sensitization in guinea pigs when tested below 10% concentration.
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.
