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EC number: 281-897-8 | CAS number: 84057-80-7
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
Zirconium propionate is not expected to be carcinogenic, since the two constituents zirconium and propionic acid are also not classified as carcinogenic. Thus, zirconium propionate 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.
Zirconium propionate is the zirconium metal salt of propionic acid, which readily dissociates to the corresponding zirconium cation and propionate anions. The zirconium cation and the propionate anion are considered to represent the overall toxicity of zirconium propionate 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 zirconium propionate 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 zirconium propionate and the individual constituents.
| Zirconium | Propionic acid (CAS# 79-09-4) | Zirconium propionate (CAS# 84057-80-7) |
Carcinogenicity | Negative | Negative | Negative |
Zirconium
No carcinogenicity data available. Nevertheless from the data available on zirconium dioxide, testing is not required as zirconium dioxide is not mutagenic and no evidence of hyperplasia or pre-neoplastic lesions is observed from the repeated dose studies.
Propionic acid
In a 2 year repeated dose toxicity study in rats, no carcinogenic effect was observed at the highest dose tested : 4000 ppm (2640 mg/kg bw). It is therefore concluded that propionic acid is negative for Carcinogenicity.
Zirconium propionate
Zirconium propionate is not expected to be carcinogenic, since the two constituents zirconium and propionic acid have not shown carcinogenic properties. Thus, zirconium propionate 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.
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