Registration Dossier
Registration Dossier
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EC number: 482-410-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The submission substance was found to be non-toxic by the oral route of exposure during an OECD Guideline study. Studies to determine the dermal and inhalation toxicity of the submission substance have not been conducted due to them being deemed inappropriate with regard to the lack of exposure by both these routes.
Physicochemical properties such as the high log Pow (> 6.50) indicate that the substance would hardly penetrate the skin so a study by the dermal route of exposure was considered as unnecessary. Uptake by inhalation is considered unlikely because of the relatively large particles, so a study by the inhalation route of exposure was considered as unnecessary.
Key value for chemical safety assessment
Additional information
A study was conducted to assess the acute oral toxicity of the submission substance in the Sprague-Dawley CD strain rat. The method used followed OECD Guidelines for Testing of Chemicals No. 420 "Acute Oral Toxicity - Fixed Dose Method." Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. At the end of the 14 -day observation period, animals were sacrificed and the LD50 was determined to be >2000 mg/kg.
The above study has been ranked Reliability 1 according to the scoring system of Klimisch et al. This ranking was deemed appropriate because the study was conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which do not affect the quality of relevant results.
Studies to assess the toxicity of the submission substance by both the dermal and inhalation ruotes of exposure were deemed inappropriate due to the lack of exposure by both these routes.
Justification for classification or non-classification
The submission substance did not meet the criteria for classification as toxic or harmful by the oral route of exposure according to the EU labelling regulations during the study. Data is lacking as regards the submission substance's classification as regards the dermal and inhalation routes of exposure.
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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