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EC number: 239-594-3
CAS number: 15546-11-9
The key study Hooftman RN & De Wolf JM (2003) was provided as the key study as the test material (dibutyltin maleate) was deemed the most structurally similar to the registration substance dibutyltin methyl maleate.In a semi-static acute toxicity test with the zebra fish Brachydanio rerio study the 96h LC50 for the test material was determined as >5.70 mg/l. The test was performed in two stages, first as a limit test and subsequently as an additional full test.The study was conducted to the OECD Guideline no. 203 and the EU Guideline no. C.1, and in compliance with the OECD Principles of Good Laboratory Practice.A further three studies were provided as supporting information.
The following data have been submitted to address the short-term
toxicity to fish endpoint:
Hooftman R. N. & De Wolf J. M. (2003). 1,3,2-Dioxastannepin-4,7-dione,
2,2-dibutyl-(dibutyltin maleate, CAS # 78-04-6): Semi-static acute
toxicity test with the zebra fish Brachydanio rerio. Testing laboratory:
TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P. O. Box
360, 3700 AJ Zeist, The Netherlands. Report no.: V4017/03. Owner
company: Organotin Environmental Programme (ORTEP) Association,
Stabilizer Task Force. Report date: 2003-09-15.
Nagase H, Hamasaki T, Sato T, Kito H, Yoshioka Y & Ose Y (1991).
Structure-activity relationships for organotin compounds on the red
killifish Oryzias latipes. Applied Organometallic Chemistry 5:91-97.
Results: DBTM - In a semi-static
acute toxicity test with the red killifish, Oryzias latipes,
conducted according to OCED Guideline 203, dibutyltin maleatewas
found to have a 48h LC50 value of 13.12 mg/l.
DBTO - In a semi-static acute
toxicity test with the red killifish, Oryzias latipes, conducted
according to OCED Guideline 203, di-n-butyltin oxide was found to
have a 48h LC50 value of 0.839 mg/l.
Steger-Hartmann T and Wendt B (1998). Acute toxicity of di-n-butyltin
oxide (ZK 26385) to the Zebra fish Danio rerio. Testing laboratory:
Schering AG, Experimentelle Toxikologie, D-13342, Berlin Germany. Report
no.: IC19. Owner company: Schering AG, Experimentelle Toxikologie,
Berlin Germany. Study number: TXST19980196. Report date: 1998-12-11.
Result: In a static acute toxicity test according to OECD Guideline 203,
10 Zebra fish (Danio rerio) were exposed to a saturated aqueous solution
of di-n-butyltin oxide. No mortality was observed in the control. One
fish was found dead after 72 hours of exposure in the saturated solution
of di-n-butyltin oxide. During exposure, the fish showed signs of
abnormal behaviour nearly at all time points. 10% mortality was
observed, therefore di-n-butyltin oxide is of low acute toxicity to fish
up to 3.10 mg/l (maximum of solubility, determined on the basis of Total
Organic Carbon (TOC) analysis).
Hooftman and De Wolf 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
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 and to GLP but
is allocated a Klimisch score of 2 as the reliability is reduced for
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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