Registration Dossier

Diss Factsheets

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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