Dibutyltin maleate

Short-term toxicity to fish

Description of key information

The following study was provided as the key study to fulfil the data requirement short-term toxicity to fish:
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.
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.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

5.7 mg/L

Additional 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.

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 following studies were provided as supporting information:

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 OECD 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 OECD 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 and so is considered the key study for this endpoint.

The study has been performed to the appropriate guideline and to GLP and is allocated a Klimisch score of 1.

Steger-Hartmann and Wendt has been performed using dibutyltin oxide and so is used a supporting information due to the fact that it is known that organotin ligand will hydrolyse to this form over time.

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 read-across purposes.

The Nagase et al (1991) studies have been allocated a Klimisch score of 4 because of missing information in the study reports and are considered to be supporting studies.