Fatty acids, tall-oil, manganese salts

Carcinogenicity

Justification for classification or non-classification

Fatty acids, tall-oil, manganese salts is not expected to be carcinogenic, since the two constituents manganese and fatty acids, tall-oil are also not classified as carcinogenic. Thus, Fatty acids, tall-oil, manganese salts is not classified according to regulation (EC) 1272/2008 as carcinogenic.

Additional information

Read-across approach

Selected endpoints for the human health hazard assessment are addressed by read-across, using a combination of data on the metal cation and the organic acid anion. This way forward is acceptable, since metal carboxylates are shown to dissociate to the organic anion and the metal cation upon dissolution in aqueous media. No indications of complexation or masking of the metal ion through the organic acid were apparent during the water solubility and dissociation tests (please refer to the water solubility and dissociation in sections 4.8 and 4.21 of IUCLID). Once the individual transformation products of the metal carboxylate become bioavailable (i.e. in the acidic environment in the gastric passage or after phagocytosis by pulmonary macrophages), the “overall” toxicity of the dissociated metal carboxylate can be described by a combination of the toxicity of these transformation products, i.e. the metal cation and carboxylate anion according to an additivity approach.

Fatty acids, tall-oil, manganese salts is the manganese metal salt of fatty acids, tall-oil, which readily dissociates to the corresponding divalent manganese cation and tallate anions. The manganese cation and the tallate anions are considered to represent the overall toxicity of Fatty acids, tall-oil, manganese salts in a manner proportionate to the free acid and the metal (represented by one of its readily soluble salts). 

A detailed justification for the read-across approach is added as a separate document in section 13 of IUCLID.

 

 

Carcinogenicity

No carcinogenicity study with Fatty acids, tall-oil, manganese salts is available, thus the carcinogenicity will be addressed with existing data on the dissociation products as detailed in the table below.

 

Table: Summary of carcinogenicity data of Fatty acids, tall-oil, manganese salts and the individual constituents.

	Manganese sulfate (CAS# 7785-87-7)	Fatty acids, tall-oil	Fatty acids, tall-oil, manganese salts (CAS# 8030-70-4)
Carcinogenicity	Negative		Negative (read-across)

 

Manganese

An extensive review of literature (Assessment of Genotoxicity and Carcinogenicity of inorganic-forms of Manganese, MHRP 2009) concluded through weight-of-evidence that the registered substance, manganese dichloride, is not carcinogenic. This is further supported by the UK HSE report Manganese and its inorganic compounds (EH64 1999), which concludes that there is no evidence linking Manganese and its inorganic compounds to carcinogenicity in humans. The Scientific Committee on Occupational Exposure Limits (SCOEL 2009) states “data on carcinogenicity mutagenicity and genotoxicity are inconclusive and inadequate to establish a definitive position on the carcinogenicity on manganese and its compounds”.

 

Tallate

Tallate is not mutagenic. Taking into account the lack of genotoxic effects, it is concluded that carcinogenicity should not be an endpoint of concern.

 

Fatty acids, tall-oil, manganese salts

Fatty acids, tall-oil, manganese salts is not expected to be carcinogenic, since the two moieties manganese and fatty acids, tall-oil have not shown carcinogenic properties. Further testing is not required. Thus, fatty acids, tall-oil, manganese salts is not to be classified according to regulation (EC) 1272/2008 as carcinogen. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.