Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The following information is available for the acute oral toxicity endpoint:
Prinsen, (2003). Tetraoctylstannane [CAS # 3590-84-9]: acute oral toxicty study with rats, Testing laboratory: TNO Nutrition and Food research. Report no.: V 4410/18. Owner company: Organotin Environmental Programme (ORTEP) Association Stabilizer Task Force.
Kopp, Gunzel, Richter (1973). Systemische Vertraglichkeitsprufung (DL50) nach einmaliger Verabreichung von ZK. 44.682 and Ratten. Testing laboratory: Schering AG. Report no.: Prot. Nr. 3532. Report date: 1973-04-19.
Prinsen, (2003), is presented as the key information as the reliability rating for this study is 1, according to the criteria of Klimisch, 1997, and so is the most reliable study.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute toxicity: oral route

In the Prinsen, (2003) study, a sample of Tetraoctylstannane [CAS # 3590-84-90] was examined for acute oral toxicity in an experiment with female rats (limit testing) according to OECD Guideline no. 423.

No mortality or clinical signs were observed after treatment with a 300 or a 2000 mg/kg b.w. dose level. Macroscopic examination of the surviving animals at the end of the observation period did not reveal any treatment-related gross changes.

Since all animals survived the 2000 mg/kg dose level, the oral LD50 of Tetraoctylstannane is considered to be higher than 2000 mg/kg body weight.

Kopp, Günzel, Richter (1973), is presented as supporting information only. The LD50 was given as > 4.0 g/kg (> 4000 mg/kg) which corroborates the results of the key study..

Acute toxicity: Dermal and Inhalation routes

No data have been provided for the dermal and inhalation routes as the substance is regarded as a transported isolated intermediate and is used under strictly controlled conditions in line with Article 18, 4.(b) of the REACH regulation EC/1907/2006 which states "procedural and control technologies shall be used that minimise emission and any resulting exposure". As such, only the data specified in Annex VII of the REACH regulation, in accordance with Article 18 (3), is required and it was considered unnecessary to generate additional data via the dermal and inhalation routes of exposure.

 

As the substance is being registered as a transported isolated intermediate, a CSR is not needed for the registration and thus DNEL values have not been calculated.

Justification for classification or non-classification

The key parameter chosen for acute toxicity for the oral route was greater than the criteria set out in Directive 67/548/EEC and also Regulation (EC) no 1272/2008, therefore classification for acute toxicity was not considered to be necessary.