Registration Dossier
Registration Dossier
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EC number: 283-480-6 | CAS number: 84649-99-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Theobroma cacao, Sterculiaceae.
Toxicological Summary
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
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
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.
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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