Registration Dossier
Registration Dossier
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EC number: 222-733-7 | CAS number: 3590-84-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 426 mg/kg bw/day
Additional information
A guideline toxic to reproduction 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.
As no significant reproductive effects were observed in the tetraoctylstannane-treated groups, the NOAEL for reproductive toxicity was established at the high-dose level (7,500 mg/kg diet which is equivalent to 445-480 mg/kg body weight in the male animals and 426-624 mg/kg body weight in the female animals).
Short description of key information:
REPRODUCTIVE TOXICITY SCREENING STUDY:
A guideline toxic to reproduction study conducted in Wistar rats was identified as the key study.
As no significant reproductive effects were observed in the tetraoctylstannane-treated groups, the NOAEL for reproductive toxicity was established at the high-dose level (7,500 mg/kg diet which is equivalent to 445-480 mg/kg body weight in the male animals and 426-624 mg/kg body weight in the female animals).
Effects on developmental toxicity
Description of key information
REPRODUCTIVE TOXICITY SCREENING STUDY:
A guideline toxic to reproduction study conducted in Wistar rats was identified as the key study.
As no significant reproductive effects were observed in the tetraoctylstannane-treated groups, the NOAEL for reproductive toxicity was established at the high-dose level (7,500 mg/kg diet which is equivalent to 445-480 mg/kg body weight in the male animals and 426-624 mg/kg body weight in the female animals).
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 426 mg/kg bw/day
Additional information
A guideline toxic to reproduction 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.
As no significant reproductive effects were observed in the tetraoctylstannane-treated groups, the NOAEL for reproductive toxicity was established at the high-dose level (7,500 mg/kg diet which is equivalent to 445-480 mg/kg body weight in the male animals and 426-624 mg/kg body weight in the female animals).
Justification for classification or non-classification
Based upon the information presented in this study, the registered substance does not meet the criteria for classification according to 67/548/EEC or EC Regulation 1272/2008.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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