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Description of key information

A guideline 28-day subacute dietary study conducted in Wistar rats was identified as the key study.
Based on the observed effects in the high-dose animals, decrease in thymus weight (male and female animals) and microscopic findings in the thymus (female animals), the No Observed Adverse Effect Level (NOAEL) for general toxicity is established at the mid-dose level (1500 mg/kg diet which is equivalent to 86-99 mg/kg body weight/day for the male animals and to 80-141 mg/kg body weight/day for the female animals.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
80 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

A guideline 28-day subacute dietary study conducted in Wistar rats was identified as the key study.

The objective of this study was to provide data on the possible reproductive and developmental effects of tetraoctylstannane [CAS # 3590-84-9] after oral administration via the diet to Wistar rats of both sexes. The study was combined with a repeated dose toxicity study, rats were fed diets containing 0, 100, 500, 2000 and 10,000 mg/tetraoctylstannane/kg diet for 14 days. In the main study, rats were fed diets containing 0, 500, 1500, 7500 mg tetraoctylstannane/ kg diet for up to 33 days (males) or during 2 weeks premating, mating, gestation and up to day 4 or 5 of lactation (females).

No treatment-related mortalities or clinical signs were observed.

Based on the observed effects in the high-dose animals, decrease in thymus weight (male and female animals) and microscopic findings in the thymus (female animals), the No Observed Adverse Effect Level (NOAEL) for general toxicity is established at the mid-dose level (1500 mg/kg diet which is equivalent to 86-99 mg/kg body weight/day for the male animals and to 80-141 mg/kg body weight/day for the female animals.


Repeated dose toxicity: via oral route - systemic effects (target organ) glandular: thyroids

Justification for classification or non-classification

Based upon the information presented in this study, with the NOAEL established as being below 150 mg/kg/bw day in a subacute study, it is considered that the substance is classified as R48/22 Harmful: danger of serious damage to health by prolonged exposure in accordance with Directive 67/548/EEC and as STOT category 2 after repeat exposure (H373) in accordance with Regulation (EC) No 1272/2008.