Cocoa, powd., alkalized

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

There is no information on the non-human skin irritation potential of cocoa powder itself, but there isin vivo,ex vivo, andin vitrodata that demonstrates a protective effect of cocoa powder extracts on skin cells (see below). There is also information on the skin irritation potential of cocoa powder from human skin sensitization/provocation studies (see section 5.3.1.2).

Human Information:

Mucous membranes are generally more sensitive to irritants. Human oral uptake of chocolate, which can be defined as cocoa powder that has not or has been partially depleted from cocoa butter, is tolerated by the mucous membranes of the mouth and gut without any signs of irritation. The same holds true for chocolate drinks, i.e., cocoa powder suspended/dissolved in water.

 

Full cocoa powder or parts of it are actually components of several skin care products, including face masks (http://www.cosmeticsdesign-europe.com/content/search?SearchText=cocoa; last visit Sep. 2012). Indeed, cocoa butter is “widely used as an active excipient in skin care products” (Gasser et al. 2008).

 

Despite the handling of cocoa powder in industrial settings over more than 200 years, there are no recorded reports of skin irritation in workers at these sites.

 

A search of PubMed with cocoa and (irritant or irritancy and skin) in title or abstract gives no publication on its irritative action. (http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed; last search Jan., 2013).

 

Cocoa powder and chocolate have both been used in several human skin sensitization studies using skin prick and dermal patch testing methods in potentially highly sensitized individuals (for example: long-term confectionery workers employed in dusty areas, children with known allergic contact dermatitis, and in patients with a history of immediate adverse reaction following food ingestion). Although in each study, some individuals demonstrated a typical sensitization response to skin challenge with chocolate and/or cocoa powder, there was no identified effect on the skin of the majority of individuals in each study following direct provocation.

 

Eye irritation:

In assays with two cocoa powder samples (assayed to be at extremes of lipid content found in commercial cocoa powders) the Bovine Corneal Opacity and Permeability (BCOP) tests were negative for corrosion and severe irritation to the eye as expected. It is believed that cocoa would cause irritation if any by a mechanical process due to its physical form as a dust and not via any chemical action of its constituents. This is based on a long history of human exposure to cocoa powder by workers and consumers.

Justification for classification or non-classification

The following information is taken into account for any hazard / risk assessment.

Skin irritation: The lack of any irritative effects of cocoa powder extracts inin vivoandex vivosystems, along with a lack of effects after oral uptake in rats and in humans, and no effects after skin contact in workers and consumers are considered to be sufficient to indicate no irritation of cocoa powder to the skin.

 

Eye irritation: The lack of positive ex-vivo findings in the BCOP assay and a lack of mucosal irritation/corrosion, or any treatment related ophthalmoscopy findings in a 104 week dietary rat carcinogenicity study, along with a lack of reported eye related damage in cocoa manufacturers and consumers of cocoa are considered to be sufficient to indicate no irritation of cocoa powder to the eye.