Registration Dossier
Registration Dossier
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EC number: 222-103-1 | CAS number: 3349-36-8
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Tsuda et al (1986). Bioconcentration of Butyltin Compounds by Round Crucian Carp. Toxicological and Environmental Chemistry Vol. 12, pp. 137-143.
Tsuda et al (1988). BIOCONCENTRATION AND METABOLISM OF BUTYLTIN COMPOUNDS IN CARP. Wat. Res. Vol. 22, No. 5, pp. 647-651, cited in Walterson et al (1994). KEMI report: Mono and Di-Substituted Organotins Used as Plastic Additives - Volume 1: Environmental Hazard Assessment. Report no.: 11/94. Owner company: THE SWEDISH NATIONAL CHEMICALS INSPECTORATE.
All studies have been allocated a Klimisch score of 4. The studies were performed on dibutyltin dichloride, which is similar to the substance in question, a read-across approach was therefore considered suitable for assessment of the bioaccumulation potential of the substance.
Key value for chemical safety assessment
Additional information
Two studies were available on a closely related substance (dibutyltin dichloride) and although individually neither of these studies is considered adequate to wholly address this endpoint, it is considered that together they provide sufficient weight of evidence to qualitatively conclude the bioaccumulation potential of the substance.
The two studies provided as a part of the weight of evidence approach are Tsuda et al (1986) and Tsuda et al (1988) which is referenced in the KEMI report (Waterson et al (1994)).
Both of the studies by Tsuda et al are considered to have been conducted to methods that deviate from the strict terms of the appropriate OECD guideline, and the parameters of the study were not wholly comparable to those required for accurate assessment of this data requirement. The studies were correspondingly assigned a reliability score of 4 (not assignable); this was based on methodological deficiencies and certain areas lacking in detail in the reporting of the studies.
The KEMI report is a comprehensive review of mono- and di-substituted organotins and references the later report by Tsuda et al (1988). The publication of a paper by a National REACH Competent Authority referencing the bioacculmulation data by Tsuda et al suggests that the information contained therein should be considered to lend strong weight to the argument that the substance is not bioaccumulative.
Both sources, though not sufficient for assessment on their own, indicate that the potential for bioaccumulation in aquatic species is low. In the absence of reliable and validated QSAR data, Bioconcentration Factors of 5 - 135, reported in the studies, can be considered to be a representative BCF value for the registered substance.
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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