Registration Dossier
Registration Dossier
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EC number: 205-249-0 | CAS number: 136-51-6
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
Calcium bis(2-ethylhexanoate) is not expected to be carcinogenic, since the two dissociation products calcium and 2-ethylhexanoic acid are also not classified as carcinogenic. Thus, calcium bis(2-ethylhexanoate) 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.
Calcium bis(2-ethylhexanoate) is the calcium salt of 2-ethylhexanoic acid, which readily dissociates to the corresponding divalent calcium cation and monovalent 2-ethylhexanoate anions. The calcium cation and the 2-ethylhexanoate anion are considered to represent the overall toxicity of calcium bis(2-ethylhexanoate) 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 calcium bis(2-ethylhexanoate) 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 calcium bis(2-ethylhexanoate) and the individual constituents.
| Calcium substances | 2-ethylhexanoic acid (CAS# 149-57-5) | Calcium bis(2-ethylhexanoate) |
Carcinogenicity | Negative | Negative | Negative |
Calcium
Taking into consideration the biochemical role of calcium in the human body and the normal daily dietary requirements, carcinogenicity is not an endpoint of concern.
2-ethylhexanoic acid
2-ethylhexanoic acid is not mutagenic in the Ames test or in mammalian cell systems both in the absence and presence of metabolic activation. 2-ethylhexanoic acid did not induce micronuclei in bone marrow of mice. Taking into account the lack of genotoxic effects, it is concluded that carcinogenicity should not be an endpoint of concern.
Calcium bis(2-ethylhexanoate)
Calcium bis(2-ethylhexanoate) is not expected to be carcinogenic, since the two dissociation products calcium and 2-ethylhexanoic acid are also not classified as carcinogenic. Further testing is not required. Thus, calcium bis(2-ethylhexanoate) is not classified according to regulation (EC) 1272/2008 as carcinogenic. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.
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