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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.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Remarks:
- Keratinosens
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Deviations:
- yes
- Remarks:
- without impact on the study conclusion (experimentation was redone due to a technical error which made results uninterpretable).
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM DB-ALM protocol 155: KeratinoSensTM
- GLP compliance:
- yes
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- Alternative methods are recommended first before performing the LLNA test.
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
In vitro test system
- Details on the study design:
- Cells (KeratinoSens™) are cultured in maintenance medium at 37°C, 5% CO2. Cells are exempt of mycoplasma. Cells were used at passage 17 in repetition 1 and passage 19 in repetition 2.
Test item
The test item was tested at 12 concentrations according to a geometric progression of ratio 2 from 0.2 μg/ml to 400 μg/ml.
Reference item
Negative control: 6 wells of solvent control (1% DMSO in treatment medium) with cells and 1 well of solvent control without cell by culture plate.
Positive control: 5 concentrations of cinnamaldehyde on each culture plate. The concentration varies from 4 to 64 μM according to a geometric progression of ratio 2.
The study was composed of two independent repetitions. For each repetition the test item and the reference items were replicated on three independent plates for the measurement of induction and two plates for the measurement of cytotoxicity. Each repetition was performed on a different day with fresh stock solution.
Results and discussion
- Positive control results:
- The positive control (cinnamaldehyde) gave the following results:
-EC1.5 = 7.19 (geometric mean)
-Imax = 6.36
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: repetition 1
- Parameter:
- other: EC1.5 (ug/mL)
- Value:
- 200
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: repetition 2
- Parameter:
- other: EC1.5 (ug/mL)
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not measured/tested
- Remarks:
- EC1.5 was not calculated since Imax was lower than 1.5
- Other effects / acceptance of results:
- The positive control (cinnamaldehyde) fulfilled the acceptability criteria of the study:
-the gene induction was statistically significant above the threshold of 1.5 in at least one dose
-the EC1.5 value was between historical data of the laboratory: mean EC1.5 value ± 2 SD
-the average induction, in each repetition, for cinnamaldehyde at 64 μM was between 2 and 8.
The negative control (control solvent) fulfilled the acceptability criteria of the study:
For each repetition, the coefficient of variation (CV) of the solvent controls (3 x 6 wells) was less than 20% (Repetition 1: CV of 16.1 and Repetition 2: CV of 17.3)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the retained experimental conditions, Caramel E150 C may be classified as not skin sensitizer.
The test method KeratinoSensTM is considered scientifically valid to be used as part of an integrated approaches to testing and assessment, to support the identification of the sensitization potential of test item for hazard classification and labeling purposes.
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.
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