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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- without impact on the study conclusion (A temperature higher than 25°C was registered on a day. The maximum value measured was 27°C.)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Three Sprague Dawley rats (SPF Caw) were used after an acclimatisation period of at least five days. The animals were nulliparous and non-pregnant. At the beginning of the study, the animals of the treated groups were 8 weeks old. They were identified prior to inclusion in the test by means of a numbered ring on the edge of one ear.
Housing: During the treatment, the animals were kept in individual cages. On D1, the animals were put together into their cage. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains dust free wood shavings which were changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry. The temperature and relative humidity of the main test were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively. The rate of air exchange was at least ten changes cycles per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Food and drink: Drinking water and foodstuff were supplied ad libitum. Microbiological and chemical analyses of the water were carried out once every six months.
Examinations of the animals
-Daily examination: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet. These observations were compared to historical control data. Observations and a mortality report were then carried out every day for 14 days.
-Periodical examinations: The animals were weighed on day 0 (just before administering the test item) then on day 2, day 7, and on day 14. Weight changes were calculated and recorded.
-Examination at the end of the test: On D14, the animals were sacrificed with sodium pentobarbital (Dolethal®). Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10 per cent of the body surface area was clear for the application of the test item CARAMEL COLOUR E150c.
Animals from treated group received by topical application, under non occlusive porous gauze dressing secured in position with a strip of surgical adhesive tape, an effective dose of 2000 mg/kg body weight administered under a volume of 1.51 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed and the treated area was rinsed with distilled water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 female rats receivent caramel at dose 2000 mg/kg bw.
- Control animals:
- no
- Details on study design:
- A preliminary study (range-finding study) was performed. Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animal by clipping. At least 10 per cent of the body surface area was clear for the application of the test item CARAMEL COLOUR E150c. The animal received by topical application, under non occlusive porous gauze dressing secured in position with a strip of surgical adhesive tape, an effective dose of 2000 mg/kg body weight administered under a volume of 1.51 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed and the treated area was rinsed with distilled water.
Results and discussion
- Preliminary study:
- At the dose of 2000 mg/kg bw, in the animal tested:
No mortality occurred during the study.
Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
The body weight evolution of the animals remained normal throughout the study.
The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item CARAMEL COLOUR E150c is higher than 2000 mg/ kg body weight by dermal route in the rat. The test item CARAMEL COLOUR E150c does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.
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