Registration Dossier
Registration Dossier
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EC number: 251-807-1 | CAS number: 34041-09-3
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
2-ethylhexanoic acid, molybdenum salt is not expected to be carcinogenic, since the two constituents molybdate and 2-ethylhexanoic acid have not shown carcinogenic properties. Thus, 2-ethylhexanoic acid, molybdenum salt is not classified according to regulation (EC) 1272/2008 as carcinogen.
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.
2-ethylhexanoic, molybdenum salt is the molybdenum metal salt of 2-ethylhexanoic acid, which readily dissociates to the corresponding molybdenum and 2-ethylhexanoate ions. These ions are considered to represent the overall toxicity of 2-ethylhexanoic, molybdenum salt 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 2-ethylhexanoic acid, molybdenum salt 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 2-ethylhexanoic acid, molybdenum salt and the individual constituents.
| Disodium molybdate (CAS# 7631-95-0) | 2-ethylhexanoic acid (CAS# 149-57-5) | 2-ethylhexanoic acid, molybdenum salt |
Carcinogenicity | Negative | Negative (Waiver) | Negative |
Disodium molybdate
The key study regarding carcinogenicity of molybdenum substances is a 2 -year inhalation toxicity and carcinogenicity study with MoO3 in rats and mice by the US National Toxicological Programme (NTP, final report 1997). No evidence of systemic carcinogenicity was seen in these inhalation study with MoO3, which is a suitable surrogate for other molybdenum substances regarding systemic effects. The marginal evidence for carcinogenicity in the lung (and other local effects in the respiratory tract) in the study with MoO3 are considered substance specific local effects without relevance for the substance under consideration in this dossier
Overall, there are no data available that would indicate that disodium molybdate is carcinogenic.
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 and no carcinogenicity studies are performed.
2-ethylhexanoic acid, molybdenum salt
2-ethylhexanoic acid, molybdenum salt is not expected to be carcinogenic, since the two constituents molybdate and 2-ethylhexanoic acid have not shown carcinogenic properties. Thus, 2-ethylhexanoic acid, molybdenum salt is not classified according to regulation (EC) 1272/2008 as carcinogen. Further testing is not required. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.
Justification for selection of carcinogenicity endpoint
Read-across information.
Short description of key information:
2-ethylhexanoic acid, molybdenum salt is not expected to be a carcinogen.
Endpoint Conclusion: No adverse effect observed (negative)
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