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Registration Dossier
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EC number: 305-748-4 | CAS number: 95009-22-6
- 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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Alkalised cocoa powder is a UVCB that is the result of a manufacturing process including the alkalisation of cocoa powder with potassium carbonate and/or sodium hydroxide. Neither alkalisation substance is present in the final product. Since the above alkalization step is taking place prior to the roasting step, ACP is considered to be the same as the EINECS-listed substance "Cocoa, powder, alkalized" with EC number 305-748-4 and CAS number 95009-22-6.
Table 2 of the CSR showed a comparison of the constituents of alkalised cocoa powder and cocoa powder and the compositions are essentially similar.
Based on the similar structures and compositions, as well as the rapid biodegradation and the overall lack of toxicity discussed in this section, cocoa powder (EC 283 -480 -6 and CAS 84649 -99 -0)
is an appropriate read-across substance for alkalised cocoa powder (EC 305 -748 -4 and CAS 95009 -22 -6). Therefore, the data presented in the IUCLID dossier for cocoa powder can be used to directly read-across to alkalised cocoa powder with respect to toxicological hazard.
Acute toxicity studies by the oral route report LD50>20g/kg bw, which is considerably above the threshold for classification in the EU.
Inhalation of cocoa powder and other organic dusts are associated with short-term effects in the respiratory tract, including reductions in ventilatory capacity. These effects are not considered to be due to biological effects of cocoa powder, but to the biological effects associated with inhalation of nuisance dusts.
Cocoa powder is not irritating to skin or to eyes, as demonstrated by the results of two bovine corneal opacity and permeability tests, which is supported by epidemiological human data.
Following repeated exposure over long periods to high levels of air-borne cocoa powder, effects on the respiratory tract of some industrial workers has been noted, and in a few of these individuals this was associated with an enhanced IgE-response. It is questionable however, whether the action of cocoa powder is a true allergenic response, or rather, a general effect resulting from inhalation of an organic dust.
In vitroandin vivostudies indicate that cocoa powder is not genotoxic.
Reproductive toxicity studies on the effects of cocoa powder on fertility and foetal development in rats and rabbits have not demonstrated adverse effects that would lead to a classification for these end-points.
On the basis of all of the toxicological data that has been accumulated on cocoa powder, this substance is not considered to be hazardous to human health for any of the identified end-points. Furthermore, due to an absence of adverse effects, quantification of DNELs (Derived No Effect Levels) is not considered to be appropriate.
Also, in relation to those end-points for which there is no derivation of DNEL (for example, irritation and sensitisation), risk characterisation is also not considered to be required as the substance is not irritating or corrosive. However, due to the physical nature of cocoa powder, in situations where dust may be generated, it would be sensible to recommend use of appropriate respiratory and other personal protection (such as goggles and gloves), and for dust concentrations (including air-borne cocoa dust) in the working environment to be kept below safe maximum occupational exposure levels.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Alkalised cocoa powder is a UVCB that is the result of a manufacturing process including the alkalisation of cocoa powder with potassium carbonate and/or sodium hydroxide. Neither alkalisation substance is present in the final product. Since the above alkalization step is taking place prior to the roasting step, ACP is considered to be the same as the EINECS-listed substance "Cocoa, powder, alkalized" with EC number 305-748-4 and CAS number 95009-22-6.
Table 2 of the CSR showed a comparison of the constituents of alkalised cocoa powder and cocoa powder and the compositions are essentially similar.
Based on the similar structures and compositions, as well as the rapid biodegradation and the overall lack of toxicity discussed in this section, cocoa powder is an appropriate read-across substance for alkalised cocoa powder. Therefore, the data presented in this IUCLID dossier for cocoa powder can be used to directly read-across to alkalised cocoa powder with respect to toxicological hazard.
Acute toxicity studies by the oral route report LD50>20g/kg bw, which is considerably above the threshold for classification in the EU. Inhalation of cocoa powder and other organic dusts are associated with short-term effects in the respiratory tract, including reductions in ventilatory capacity. These effects are not considered to be due to biological effects of cocoa powder, but to be systemic in character.
Cocoa powder is not irritating to skin or to eyes, as demonstrated by the results of two bovine corneal opacity and permeability tests, which is supported by epidemiological human data.
Following repeated exposure over long periods to high levels of air-borne cocoa powder, effects on the respiratory tract of some industrial workers has been noted, and in a few of these individuals this was associated with an enhanced IgE-response. It is questionable however, whether the action of cocoa powder is a true allergenic response, or rather, a general effect resulting from inhalation of an organic dust.
In vitroandin vivostudies indicate that cocoa powder is not genotoxic.
Reproductive toxicity studies on the effects of cocoa powder on fertility and foetal development in rats and rabbits have not demonstrated adverse effects that would lead to a classification for these end-points.
On the basis of all of the toxicological data that has been accumulated on cocoa powder, this substance is not considered to be hazardous to human health for any of the identified end-points. Furthermore, due to an absence of adverse effects, quantification of DNELs (Derived No Effect Levels) is not considered to be appropriate.
Also, in relation to those end-points for which there is no derivation of DNEL (for example, irritation and sensitisation), risk characterisation is also not considered to be required as the substance is not irritating or corrosive. However, due to the physical nature of cocoa powder, in situations where dust may be generated, it would be sensible to recommend use of appropriate respiratory and other personal protection (such as goggles and gloves), and for dust concentrations (including air-borne cocoa dust) in the working environment to be kept below safe maximum occupational exposure levels.
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