Registration Dossier

Administrative data

Description of key information

The key information for each exposure route for acute toxicity was chosen as follows:
Acute toxicity: oral
5 studies were available to address the acute toxicity endpoint, with one from a literature source. Terrell, Y (1979) has been selected as key study.
Terrell, Y (1979). ACUTE ORAL TOXICITY OF: 1185-13 (DIOCTYLTIN DICHLORIDE), 28GO82, 28HO47, 1185-114, 1219-21 (DIMETHYLTIN DICHLORIDE), 1185-150, 1185-119 AND 1185-138 IN WEANLING SPRAGUE-DAWLEY RATS. Testing laboratory: Cannon Laboratories, Inc., P. O. Box 3627, Reading Pa., 19605. Owner company: Cincinnati Milacron, West Street, Reading, Ohio 45215. Report date: 1979-03-21.
Sarasin. G (1982). Acute Oral LD50 in the Rat. Testing laboratory: Ciba-Giegy LTD. Report no.: 820546. Owner company: KA. Report date: 1982-06-30.
Anon. (1978). Extended Acute Oral LD50 Studies of Nine Studies. Testing laboratory: Hill Top - Toxicology, Miamiville, Ohio, USA. Report no.: 77-1094-21. Owner company: Cincinnati Milacron. Report date: 1978-05-26.
Günzel. P (1968). Systemic Tolerance to a Single Application (DL50). Testing laboratory: Schering AG. Report no.: 21.979. Owner company: Crompton GmbH. Report date: 1968-08-15.
Mesch, K. A. and Kugele. T. G. (1992). Use of Organotin Stabilizers - Risk Assesment Analysis. Journal of Vinyl Technology, September 1992, Vol.14, No. 3. Report no.: Vol 14, No. 3.
Acute toxicity: dermal
No information was available for this exposure route.
Acute toxicity: inhalation
Sachsse K (1976). ACUTE INHALATION TOXICITY IN THE RAT OF TK 11339. Testing laboratory: Ciba-Giegy Limited, Basle, Switzerland. Report no.: Siss 5354. Owner company: Ciba-Giegy Limited, Basle, Switzerland. Study number: Siss 5354. Report date: 1976-05-14.
Sachsse, 1976, is the only four hour exposure study available and therefore was considered to provide a reliable result for hazard assessment purposes. Additional data is provided for supporting purposes only.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
3 300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
439 mg/m³

Additional information

Acute Toxicity: oral

3 reliable sources of information are available for this exposure route, Sarasin, 1982; Anon, 1978, and Terrell, 1979, are all rated as reliability 2 according to the criteria of Klimisch et al, 1997, based upon their test methodologies and depth of reporting of test substance information, methodology and results.

Mesch & Kugele, 1992, was given a reliability score of 4 according to the above criteria due to insufficient reporting of methodology and result to allow for a thorough reliability assessment to be completed.

Günzel, 1968, was assigned a reliability score of 3 according to the above criteria as information on test substance, necropsy and test conditions were not reported.

 

The key value was chosen on a worst case basis from Terrell, 1979. This study was conducted with a similar methodology to OECD guideline 401 and EPA.OPPTS 870.1100. Testing was conducted using the gavage method with the test material suspended in corn oil, doses of 1000, 5000, 10000 and 15000 mg/kg bw (actual ingested) were used in the study. Based upon mortality observed during the study the LD50 of 3300 mg/kg bw was calculated for the registered substance.

Acute Toxicity: inhalation

Several sources of information were available for this route of exposure. Gleason, 1976 and Sachsse, 1976, were both rated as reliability 2 according to the criteria of Klimisch et al, 1997, based upon the level of reporting of methodologies and results.

The principles of the test method employed in Luy, 1976, would severely affect the reliability of the study result, and the study was therefore awarded the reliability score of 3 according to the above criteria.

Sachsse, 1976, was the only study which was conducted with a 4 hour exposure period, meaning it is the only study that could be used to assess the potential acute toxicity hazard of the registered substance by the inhalation route. Sachsse, 1976, was therefore selected as the key study. Sachsse, 1976, reported a result of 0.439 mg/l after a 4 hour exposure. A value of 439 mg/m3 is equivalent to 0.439 mg/L.

Acute toxicity: dermal

No information for this route of exposure was available.

Justification for classification or non-classification

On the basis of the available data, the substance should be classified as toxic via the inhalation route. Under the EU Dangerous Substances Directive (67/548/EEC), dioctyltin dichloride should be classified as T; R23, and under EC Regulation 1272/2008 dioctyltin dichloride should be classified as a category 2 toxin via the inhalation route H33 (Fatal if inhaled) with the signal word "Danger".