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Toxicological information

Neurotoxicity

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Description of key information

The following studies are available to address the neurotoxicity endpoint:
Alam, M. S., Husain, R., Srivastava, S. P. and Seth, P. K. (1988). Influence of di-butyltin dilaurate in brain neurotransmitter systems and behavior in rats. Arch. Toxicol. 61:373-377. Testing laboratory: Industrial Toxicology Research Centre.
Alam, M. S., Husain, R., Seth, P. K. and Srivastava, S. P. (1993). Age and sex related behavioral changes induced by dibutyltin dilaurate in rats. Bull. Environ. Contam. Toxicol. 50:286-292. Testing laboratory: Industrial Toxicology Research Centre.
EFSA (2004) Opinion of the Scientific Panel on Contaminants in the Food Chain on a request from the Commision to assess the health risks to consumers associated with exposure to organotins in foodstuffs (Question No EFSA-Q-2003-110). The EFSA Journal 102: 1-119.
Subramoniam, A. R., Husain, R. and Seth, P. K. (1991). Reduction of phosphoinositides and diacylglycerol levels in repeatedly dibutyltin-dilaurate-treated rat brain. Toxicology Letters 57:245-250. Testing laboratory: Industrial Toxicology Research Centre, Lucknow, India.
All studies have been allocated a Klimisch score of 2 except for EFSA (2004) which has been allocated a score of 4 because it is a literature review and so is considered a secondary source. Alam et al (1988) is considered to be the key study for this endpoint.

Key value for chemical safety assessment

Additional information

For inclusion in Annex I the proposed classification was Reproductive Category 2 with R60 – May impair fertility and R61 – May cause harm to unborn child. Available data support such classification.The SPCFC (2004) review of organotins considered evidence of neurotoxicity and concluded that, while there is clear-cut evidence of neurotoxicity with regard to trimethyl tin, triethyltin and triphenyltin, other tri- and also di-alkyltins are less or - possibly - not neurotoxic at all. Available animal data indicate that the substance can decrease neurotransmitters levels in the central nervous system, and reduce spontaneous or anphetamine-induced motor activity. The LOEL for effects on neurotransmitter can be set at 20 mg/kg/day, given for three consecutive days and not causing mortality among the treated animals. It is however clear from available studies, that any potential neurotoxicity is not the most sensitive marker of dibutyltin toxicity.

Justification for classification or non-classification