Registration Dossier
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EC number: 201-077-5 | CAS number: 78-04-6
Water solubility
Administrative data
Link to relevant study record(s)
Description of key information
The following study was performed to fulfil the data requirement for the water solubility of dibutyltin maleate:
Walker JA & White DF (2010) DETERMINATION OF GENERAL PHYSICO-CHEMICAL PROPERTIES. Testing laboratory: Harlan Laboratories Limited, Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD, UK. Owner company: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160, Brussels, BELGIUM. Report No.: 3109/0048. Report date: 2010-08-10
The water solubility of the test item has been determined to be less than 1.00 x 10^-2 g/l of solution at 20.0 ± 0.5°C, by visual assessment using a flask method, based on Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995 and Method A6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008.
During method development, it was found that the test item was insoluble in all of the typical laboratory solvents tested; the solvents used were methanol, acetonitrile, tetrahydrofuran, dichloromethane, water, hexane, chloroform, toluene, ethyl acetate, methyl-tert-butyl ether and isooctane and so therefore the test item can be interpreted as being insoluble.
Available data on the solubility of the test material was submitted as the collective findings of the solubility of dibuytltin maleate as the freshly prepared WSF in the test mediums from the ecotoxicity test:
Hooftman R.N. and De Wolf J.M. (2003) Report #: V4017/03, V4017/04 and V4017/05. Testing laboratory: TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P.O. Box 360, 3700 AJ Zeist, The Netherlands. Owner company: Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force.
For the acute B. rerio (fish) study, the 100% WSF was 5.70 mg dibutyltin maleate (DBTM)/L. For the acute daphnia study, the 100% WSF was 7.96 mg (DBTM)/L. For the S. subspicatus study, the 99% WSF was 4.08 mg DBTM/L.
Key value for chemical safety assessment
Additional information
Value used for CSA:< 10 mg/l at 20.0 ± 0.5°C
A reliability rating of 1 was assigned to the key study, Walker & White (2010), according to the criteria of Klimisch, 1997 as the study was conducted in accordance with recognised guidelines and GLP, however it was not technically feasible to undertake this study and so a visual study was carried out. It is not possible to visually assess water solubility at less than 10 mg/L and so this value should be taken with caution as it was noted in the discussion that during method development, it was found that the test item was insoluble in all of the typical laboratory solvents tested; the solvents used were methanol, acetonitrile, tetrahydrofuran, dichloromethane, water, hexane, chloroform, toluene, ethyl acetate, methyl-tert-butyl ether and isooctane and so therefore the test item can be interpreted as being insoluble.
Supporting information is also available from various aquatic studies (Hooftman R.N. and De Wolf J.M. (2003) Report #: V4017/03, V4017/04 and V4017/05.), where the water solubility has been estimated.
An estimate of the water solubility of dibutyltin maleate was obtained from the freshly prepared 99 -100% Water-soluble fraction (WSF) used to conduct the GLP ecotoxicity studies. The 99 -100% WSF were prepared at a loading rate of 100 mg/L. The 99 -100% WSFs were analyzed on the basis of the alkyltin, dibutyltin and all measured dibutyltin was attributed to the named substance. The preparation of the WSF allowed both the solubilized portion of the test substance, the hydrolysis products, and trace impurities to be present in the medium used to conduct the ecotoxicity studies. For the acute B. rerio study, the measured concentration of the freshly prepared 100% WSF was 5.70 mg dibutyltin maleate (DBTM)/L. For the acute daphnia study, the measured concentration of the freshly prepared 100% WSF was 7.96 mg (DBTM)/L. For the S. subspicatus study, the measured concentration of the freshly prepared 99% WSF was 4.08 mg DBTM/L.
The water soluble fraction is thought to be between 4.08 -7.96 based on the three ecotoxicology studies
Acceptable well-documented study reports which meets basic scientific principles, hence Klimisch 2 assigned.
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