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Description of key information

Repeated dose toxicity: oral, 002: 6.4 mg/kg bw/day male rats and 6.8 mg/kg bw/day for females based on decreased thymus weight. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
6.4 mg/kg bw/day
Study duration:

Additional information

Although Repeated dose toxicity: oral, 001 was the study with the worst case result, Repeated dose toxicity: oral, 002 was selected as key as it was considered more reliable. It is a more recent study which used GS-MS to determine the concentration of chemical in the diet. The study was also performed to GLP standard and following a recognised OECD guideline. Thus, this study could be considered as key.

Based on the decreased thymic weights and associated histopathological findings in animals of the 500 mg/kg group, the No Observed Adverse Effect Level (NOAEL) in the sub-chronic toxicity study was placed at 100 mg Trichlorooctylstannae/kg diet. This level was equivalent to 6.4 mg/kg body weight/day in males and 6.8 mg/kg body weight/day for females.

Repeated dose toxicity: oral, 001: 1.5 - 4.8 mg/kg bw/day in males and 1.7 - 4.6 mg/kg bw/day in females based on decreased thymus weight.

Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: thymus

Justification for classification or non-classification

Taking the male NOAEL of 6.4 mg/kg body weight/day, it has been shown that trichlorooctylstannane is harmful to rats through prologed exposure via the oral route. In light of this, trichlorooctylstannane should be classified with Xn, R48/22 in accordance with the european DSD 67/548/EEC. The target organ for effect is the thymus. The substance should be classified as STOT RE2 (Oral) with the signal word Warning and H373 in accordance with the CLP 1272/2008.