Registration Dossier
Registration Dossier
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EC number: 200-268-0 | CAS number: 56-35-9
Endpoint summary
Administrative data
Description of key information
Health surveillance data:
From the five available studies, it was apparent that some dermal intolerance to TBTO occurs under “realistic conditions” (i.e. a typical working day).
The further studies investigated the level of exposure to TBTO in an industrial setting including potential dermal contact and inhalation exposure. The studies demonstrate a level of exposure (and some minimal excretion in the urine) though this does not give a true measure of release from processes or how much of the concentration present in the workers environment is absorbed.
Exposure related observations:
The report is a summary of exposure studies that were conducted for operators that use wood preservatives containing TBTO, proposals for engineering controls, information relating to personal protective equipment, and a proposed risk assessment for users. The extent of respiratory exposure was monitored with full-shift monitoring by personal samples. Results indicate a low level of exposure far below the current occupational exposure standards. Monitoring exposure to TBTO through a full shift, and during the period immediately following the opening of treatment plants, results suggest that the maximum potential is below the current occupational exposure standards. Exposure is substantially reduced, but not eliminated by the PPE used.
Additional information
Health surveillance data:
All studies were provided for information purposes. Kochanowska-Oses M (1986) was assigned a reliability score of 3 (not reliable) due to methodological deficiencies (irritation was noted in the vehicle control). Schultze P (1991) was assigned a reliability score of 3 (not reliable) also due to methodological and reporting deficiencies. The second Schultze P (1991) study was assigned a reliability score of 2 (reliable with restrictions) as the study was performed to a good scientific standard. Schobel C & Wendt H (1986) was assigned a reliability score of 3 (not reliable) due to the interference of the formulation base inducing irritation without the presence of the test material.
Exposure related observations:
Anon. (1991) was provided for information purposes only. As the study lacked detail in areas of the reporting of the methods and the results, the study was assigned a reliability score of 4 (not assignable) as it was not possible to make an accurate assessment of the data from the level of reporting.
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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