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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.