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Administrative data

Description of key information

Subchronic repeated-dose (90 day) studies are available for the two hydrolysis products of tin bis(2 -ethylhexanoate), stannous chloride and ethylhexanoic acid. These studies report a decrease in body weight gain at higher doses for both materials and mild effects on liver and kidney weights and liver histopathology for EHA only. The liver effects for EHA were considered to be adaptive in nature and not toxic effects. The NOAELs for both materials were nearly the same, 300 mg/kg/d.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subchronic
Species:
rat
System:
hepatobiliary

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Tin bis(2 -ethylhexanoate), stannous chloride and EHA have all been evaluated in repeat-dose subacute oral toxicity studies in rats. These studies have been assigned a K-2 evaluation. All three materials had a low order of toxicity in these study protocols. Body weight gain depression was seen at 750 or 800 mg/kg/d doses, while a dose of 3000 mg/kg/d was needed to cause body weight depression for stannous chloride. In these studies, none of the three substances caused serious target organ toxicity even at very high doses. EHA caused slight effects in liver but only at a dose of 2728 mg/kg, males and 3139 mg/kg, female; tin bis(2 -ethylhexanoate) did not have target organ effects including liver and kidney, but doses in this study only went as high as 750 mg/kg/d. No pathology was noted for stannous chloride, but liver and kidney were not weighed or evaluated for histopathology in this study. For the three test substances, the LOAELs ranged between 706 -1608 mg/kg; NOAELs ranged between 250- 706 mg/kg/d.

Subchronic repeated-dose (90 day) studies are available for the two hydrolysis products of tin bis(2 -ethylhexanoate), stannous chloride and ethylhexanoic acid. These studies reported a decrease in body weight gain at higher doses for both materials and mild effects on liver and kidney weights and liver histopathology for EHA only. The liver effects for EHA were considered to be adaptive in nature and not toxic effects. The NOAELs for both materials were nearly the same, 300 mg/kg/d.

Justification for classification or non-classification

For the subacute oral toxicity studies on tin bis(2 -ethylhexanoate) and the two hydrolysis products all three materials had a low order of toxicity.

In subchronic studies on the two hydrolysis products, a decrease in body weight gain at higher doses for both materials and mild effects on liver and kidney weights and liver histopathology for EHA only were observed. The liver effects for EHA seen in subchronic studies were considered to be adaptive in nature and not toxic effects.

No repeated dose classification is necessary.