Registration Dossier
Registration Dossier
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EC number: 432-240-0 | CAS number: 12056-51-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Based on the existing sub-chronic inhalation study and toxicokinetic properties for TXAX, the substance is not absorbed via inhalation and no significant systemic effects were observed at any dose level tested in the repeat dose inhalation studies. The effects observed in the 90-day repeated dose study was considered to be due to the material being phagocytosed by alveolar macrophages and that the material accumulates in these macrophages and that is the limit to systemic exposure (Section 7.5.3 Repeated dose toxicity: inhalation). Therefore there is no value in conducting an OECD 421 study – the results will not be influenced by systemic toxicity.
The attached chemical safery report demonstrates that potential health risks from acute and long-term occupational inhalation exposure to TXAX are adequately controlled under the conditions of use given in the respective exposure scenarios . The fibre-based and dust-based risk characterisation ratios for potential adverse health affects that may arise from such exposure are all well below 1 for all identified uses.
Short description of key information:
Based on the existing sub-chronic inhalation study and toxicokinetic properties for the substance, the substance is not absorbed via inhalation and no significant systemic effects were observed at any dose level tested in the repeat dose inhalation studies. The effects observed in the 90-day repeated dose study was considered to be due to the material being phagocytosed by alveolar macrophages and that the material accumulates in these macrophages and that is the limit to systemic exposure (Section 7.5.3 Repeated dose toxicity: inhalation). Therefore there is no value in conducting an OECD 421 study – the results will not be influenced by systemic toxicity.
The attached chemical safery report demonstrates that potential health risks from acute and long-term occupational inhalation exposure to the substance are adequately controlled under the conditions of use given in the respective exposure scenarios . The fibre-based and dust-based risk characterisation ratios for potential adverse health affects that may arise from such exposure are all well below 1 for all identified uses.
Effects on developmental toxicity
Description of key information
Based on the existing sub-chronic inhalation study and toxicokinetic properties for the substance, the substance is not absorbed via inhalation and no significant systemic effects were observed at any dose level tested in the repeat dose inhalation studies. The effects observed in the 90-day repeated dose study was considered to be due to the material being phagocytosed by alveolar macrophages and that the material accumulates in these macrophages and that is the limit to systemic exposure (Section 7.5.3 Repeated dose toxicity: inhalation). Therefore there is no value in conducting studies in developmental toxicity / teratogenicity are not conducted based on the lack of bioavailability.
The attached chemical safery report demonstrates that potential health risks from acute and long-term occupational inhalation exposure to the substance are adequately controlled under the conditions of use given in the respective exposure scenarios . The fibre-based and dust-based risk characterisation ratios for potential adverse health affects that may arise from such exposure are all well below 1 for all identified uses.
Additional information
Based on the existing sub-chronic inhalation study and toxicokinetic properties for the substance, the substance is not absorbed via inhalation and no significant systemic effects were observed at any dose level tested in the repeat dose inhalation studies. The effects observed in the 90-day repeated dose study was considered to be due to the material being phagocytosed by alveolar macrophages and that the material accumulates in these macrophages and that is the limit to systemic exposure (Section 7.5.3 Repeated dose toxicity: inhalation). Therefore there is no value in conducting studies in developmental toxicity / teratogenicity are not conducted based on the lack of bioavailability.
The attached chemical safery report demonstrates that potential health risks from acute and long-term occupational inhalation exposure to the substance are adequately controlled under the conditions of use given in the respective exposure scenarios . The fibre-based and dust-based risk characterisation ratios for potential adverse health affects that may arise from such exposure are all well below 1 for all identified uses.
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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