Registration Dossier
Registration Dossier
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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.
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EC number: 232-435-9 | CAS number: 8028-89-5 The substance obtained by controlled heat treatment of food-grade carbohydrates. Food-grade acids, alkalies, and salts may be used to assist carmelization. Food-grade antifoaming agents may be used in an amount not greater than that required to produce the intended effect. Consists essentially of colloidal aggregates that are dispersible in water but only partly dispersible in alcohol-water solutions. Depending upon the particular carmelizing agent used, may have a positive or negative colloidal charge in solution.
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Absence of mutagenic activity in Salmonella and of clastogenic activity in CHO cells of caramel colours I, II, III and IV
- Author:
- Allen JA et al.
- Year:
- 1 992
- Bibliographic source:
- Fd Chem. Toxic. Vol 30, No 5, pp. 389-395
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Caramel (color)
- EC Number:
- 232-435-9
- EC Name:
- Caramel (color)
- Cas Number:
- 8028-89-5
- Molecular formula:
- C6H12OH
- IUPAC Name:
- Caramel
Constituent 1
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced S9 mix, prepared from rat liver
- Test concentrations with justification for top dose:
- 2.5, 5, 10, 20 mg/plate (standard plate-incorporation assay)
0.01, 0.1, 1, 10 mg/plate (pre-incubation assay) - Vehicle / solvent:
- sterile distilled water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 4-nitro-o-phenylenediamine, 2-aminoanthracene, neutral red
- Details on test system and experimental conditions:
- Permanent stock cultures of strains TA1535, TA1537, TA1538, TA98 and TA100 were maintained frozen in nutrient broth containing 10% (v/v) dimethyl sulphoxide at -196°C. The histidine requirement, ampicillin and crystal violet sensitivity, and mutational response of the strains were checked using the techniques recommended by Ames et al. (1975). Bacteria were thawed and cultured at 37°C in Oxoid Nutrient Broth No. 2 for 18 hr. 0.1 ml of the appropriate bacterial culture containing approx. 2 x 108 cells together with 0.5ml Aroclor-induced S-9 mix, prepared from rat liver according to the methods of Ames et al. (1975), or 0.5 ml 0.1 M-sodium phosphate buffer (pH 7.4) were combined with 0.1 ml test solution and 2ml histidine-deficient agar and layered on to 15 ml pre-poured minimal glucose agar.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In both assays (pre-incubation assay and standard plate-incorporation assay), caramel E150 class III was not mutagenic in bacteria, with or without metabolic activation.
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