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EC number: 239-594-3
CAS number: 15546-11-9
The following studies have been submitted to address the immunotoxicity endpoint:Li, A. P., Dahl, A. R. and Hill, J. O. (1982). In Vitro Cytotoxicity and Genotoxicity of Dibutyltin Dichloride and Dibutylgermanium Dichloride. TOXICOLOGY AND APPLIED PHARMACOLOGY 64, 482-485.Penninks, A. H. and Seinen, W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.Schobel, C. (1991). ZK 22.663: Local dermal tolerance test in rats after a single application and a subsequent rinsing. Report no.: IC 1/91. Report date: 1991-06-13.Seinen, W. and Penninks, A. (1979). IMMUNE SUPPRESSION AS A CONSEQUENCE OF A SELECTIVE CYTOTOXIC ACTIVITY OF CERTAIN ORGANOMETALLIC COMPOUNDS ON THYMUS AND THYMUS-DEPENDENT LYMPHOCYTES. Ann. N. Y. Acad. Sci. USA. 320:499-517.Seinen, W., Vos, J. G., van Kreiken, R., Penniks, A., Brands, R. and Hooykaas, H. (1977). Toxicity of Organotin Compounds. III. Suppression of Thymus-Dependent Immunity in Rats by Di-n-Butyltindichloride and Di-n-Octyltindichloride. TOXICOLOGY AND APPLIED PHARMACOLOGY 42, 213-224.Snoeij, N. J., Penninks, A. H. and Seinen, W. (1988). Dibutyltin and tributyltin compounds induce thymus atrophy in rats due to a selective action on thymic lymphoblasts. Int. J. Immunopharmac. 10: 891-899.DeWitt et al, 2005, Immune Responses in Sprague–Dawley Rats Exposed to Dibutyltin Dichloride in Drinking Water as Adults, Journal of Immunotoxicology, 2:151–160, 2005.DeWitt et al, 2005, Developmental Exposure to 1.0 or 2.5 mg/kg of Dibutyltin Dichloride Does Not Impair Immune Function in Sprague-Dawley Rats, Journal of Immunotoxicology, 3:245–252, 2006.Schobel (1991), Seinen et al (1977), Snoeij et al (1988), De Witt et al (2005) and De Witt et al (2006) have been allocated a Klimisch score of 2 with Seinen et al (1977) and Snoeij et al (1988) considered to be the key studies for this endpoint.
According to the European Food Safety
Authority (EFSA) Option of the Scientific Panel on Contaminants in the
Food Chain on request from the Commission to assess the risks to
consumers associated with exposure to organotins in foodstuffs (2004), specific
experimental data for Dibutyltin (chloride) indicate immunotoxic effects
at doses as low as 1 mg/kg bw in preweaning exposure studies. This value
is then apparently disregarded, and a LOAEL for DBT is cited as 2.5
mg/kg bw/day. The EFSA Option also indicate read-across from tributyltin
to dibutyltin to be appropriate since the mechanism of action is similar
and the immunotoxicity of TBT may be attributable to DBT as a
metabolite; an immunotoxicity NOAEL for TBT is identified at 0.025 mg/kg
bw/day by repeated dietary exposure. It
must be noted that dose spacing in the critical study of TBTO (Wester et
al 1988, 1990) is large and the NOAEL correspondingly imprecise. Further,
if toxicity of TBTO is even in part due to formation of DBT as the
ultimate toxicant, then a NOAEL based on an appropriate study of DBTC is
the preferable endpoint.
Modern and robust studies of the
immunotoxicity of DBTC in adult rats and in pups exposed during
gestation and lactation (DeWitt et al, 2005, 2006) found no repeatable
effect on immune function at doses up to 2.5 mg/kg bw/day, although at
this dose an effect on bodyweight was reported (possibly due to
palatability); 1 mg/kg bw/day was a NOAEL. In a series of other
appropriate studies of the substance (Gaunt et al., 1968; Pennincks et
al., 1982; Osterburg, 1993; Waalkens et al., 2003) dose levels of
approximately 2-2.5 mg/kg/bw/day are an inconsistent NOAEL/LEL; but no
effects are detected at 1 mg/kg bw/day or below.The
EFSA Opinion of the Scientific Panel on Contaminants in the Food Chain
on a request from the Commission to assess the health risks to consumers
associated with exposure to organotins in foodstuffs (2004),did
not include the significant studies by Osterburg (1993), Waalkens
(2003), and DeWitt et al (2005, 2006). Use of a NOAEL at 0.3 mg/kg
bw/day from Waalkens (2003) for DNEL setting is therefore a robust and
The substance is classified and labelled with
T; R48/25 due to toxicity to the immune system at doses below 50 ppm in
diet. Further, the substance is assigned to STOT (Specific Target Organ
Toxicant) - single exposure Category 1 based on results obtained in
Snoeij, N. J., Penninks, A. H. and Seinen, W. (1988) which indicate 50%
reduction of thymus weight following a single oral dose of 18 mg/kg bw.
Signal word: Danger; Hazard statement: H370 Causes damage to thymus.
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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