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EC number: 239-594-3
CAS number: 15546-11-9
The following studies have been submitted:Hooftman R. N. and De Wolf J. M. (2003). 1,3,2-Dioxastannepin-4,7-dione, 2,2-dibutyl-(dibutyltin maleate, CAS # 78-04-6): Static acute toxicity test with the crustacean species Daphnia magna. Testing laboratory: TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P. O. Box 360, 3700 AJ Zeist, The Netherlands. Report no.: V4017/04. Owner company: Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force. Report date: 2003-09-15.In this static acute toxicity test with the crustacean species Daphnia magna, the 48h EC50 for the test material was calculated to be 0.21 mg/L (2.7 vol. % of the saturated solution) and the observed 48h NOEC was 0.079 mg/L (1.0 vol% of the saturated solution), based on the mobility and condition of the test and the condition of the test animals.Steger-Hartmann, T. & Schmidt, M. (1998). Acute immobilization test of di-n-butyltin oxide (ZK 26385) with Daphnia magna. Testing laboratory: Schering AG, Experimentelle Toxikologie, D-13342 Berlin, Germany. Report no.: IC26. Owner company: Schering AG, Experimentelle Toxikologie, Berlin, Germany. Study number: TXST19980203. Report date: 1998-12-03.Result: The EC50 for 48 hours for di-n-butyltin oxide was determined to be 2.0 mg/L based on Total organic Carbon (TOC) concentration analysis. The highest concentration with no effect was 1.1 mg/l.Hooftman and De Wolf (2003) has been performed using dibutyltin maleate (CAS: 78-04-6) and is being used for read-across purposes to fulfil the endpoint for dibutyltin methyl maleate (CAS: 15546-11-9). Dibutyltin maleate is determined to be the structure most similar to dibutyltin methyl maleate and so this study is considered the key study for this endpoint.The supporting study, Steger-Hartmann and Schmidt (1998) was performed on dibutyltin oxide. The study was performed to the guideline and to GLP but is allocated a Klimisch score of 2 as it was performed on a read-across substance.
The key study Hooftman R. N. and De Wolf J. M. (2003) was performed to
the OECD guideline 202 and in compliance with GLP, the study was
considered reliable and adequate for assessment, however as the study
was performed on a read-across substance, the study was assigned a
reliability score of 2. In a static acute toxicity test with the
crustacean species Daphnia magna study, the 48h EC50 for the test
material was calculated to be 0.21 mg.l-1(2.7 vol. % of the
saturated solution) and the observed 48h No Observable Effect
Concentration (NOEC) was 0.079 mg.l-1(1.0 vol% of the
saturated solution), based on the mobility and condition of the test
animals, respectively. Partial immobility was observed at 3.2 vol. % and
the higher dilutions tested. At 1.0 vol. %, one animal was immobile,
however according to the OECD guideline 10% immobility is allowed and
therefore this immobility is not taken into account to estimate the NOEC
value for mobility. In addition effects with respect to condition were
limited to one single slow swimming animal at 10 vol. %. These data
support the conclusion that the NOEC for both the mobility and condition
endpoints is 1.0 vol. %. There were no immobile animals in the control
medium at the end of the test.
The supporting study Steger-Hartmann, T. & Schmidt, M. (1998) was
performed to the OECD guideline 202. The study was assigned a
reliability score of 2. Twenty juvenile Daphnia magna were
exposed to four test concentrations of di-n-butyltin oxide and 20 for
the tap water control. The Daphnia were exposed for a period of
48 hours under static conditions. Immobilization was recorded at 24
hours and 48 hours. For the preparation of the test solutions a
suspension with a nominal loading of 100 mg/l was stirred for 24 hours.
This suspension was filtered through a glassfibre filter. The resulting
solution served as the highest concentration (saturated solution). Since
in a preceding range-finding test, the EC50/48 h was estimated between
the saturated solution and a 1:10 dilution, the saturated solution was
diluted 1:2, 1:4, 1:8 for definitive testing. The test temperature was
in the range of 20.1 to 20.7 degrees C, the pH ranged between 7.7 and
8.6, and the oxygen concentration between 8.2 and 8.7 mg/l. The
light/dark rhythm was adjusted to 12 hours/12 hours. The organic carbon
concentration of the highest test solution (saturated) was analyzed with
a Total Organic Carbon (TOC) analyzer at the start of exposure and 48
hours thereafter. The substance concentration was calculated on the
basis of the molecular formula. The calculated concentration of the
saturated solution was 6.8 mg/l at the beginning of the test and 1.6
mg/l at the end of the exposure period with a mean of 4.2 mg/l. The
concentrations of the further dilutions were extrapolated. Statistical
evaluation regarding the observations of immobilization was performed by
probit analysis. Immobilized Daphnia were observed in the test
concentrations containing 2.1 and 4.2 mg/l di-n-butyltin oxide,
calculated on the basis of TOC analysis. The EC50 for 48 hours for
di-n-butyltin oxide was determined to be 2.0 mg/l based on TOC
concentration analysis. The highest concentration without effect was 1.1
Study Hooftman and De Wolf (2003) has been performed using dibutyltin
maelate (CAS: 78-04-6) and is being used for read-across purposes to
fulfil the endpoint for dibutyltin methyl maleate (CAS: 15546-11-9).
Dibutyltin maleate is determined to be the the structure most similar to
dibutyltin methyl maleate and so this study is considered the key study
for this endpoint.
The study has been performed to the appropriate guideline and to GLP,
however as the study is being used for read-across purposes the Klimisch
score has been reduced from a 1 to a 2.
The study has been performed to the appropriate guideline but is
allocated a Klimisch score of 2 as the reliability is reduced for
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