Registration Dossier

Administrative data

Description of key information

Oral:
The acute oral LD50 of TK 10708 in rats of both sexes observed over 14 days is 2071 mg/kg in a study conducted using a method which is considered similar to that in OECD Guideline 401. The test material is considered to be slightly toxic to the rat by this route of administration.
Dermal:
The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat observed over 14 days was determined to be greater than 2000 mg/kg bodyweight (in an GLP study conducted to OECD 402). Irritation was observed, and one female animal exhibited some symptoms of toxicity, however the test material did not meet the criteria for classification as acutely toxic via the dermal route.
Inhalation:
A waiver has been submitted to address the acute toxicity: inhalation endpoint on the basis of lack of exposure

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 071 mg/kg bw

Additional information

The following studies are available to address the acute oral toxicity endpoint:

Sarasin, G. (1981). Report on Acute Oral LD50 in the Rat of TK 10708. Testing laboratory: Ciba-Geigy Limited. Report no.: Project No. 811182. Owner company: Plastics and Additives Division, CIBA-GEIGY Ltd. Report date: 1981-11-13.

Schafer, E. W. and Bowles, W. A. (1985). Acute oral toxicity and repellancy of 933 chemicals to house and deer mice. Archives of Environmental Contamination and Toxicology. 14:111-129. Testing laboratory: U. S. Department of Interior - Fish and Wildlife Service.

Result: These authors reported an ALD (approximate lethal dose) for dibutyltin dilaurate of 710 mg/kg in wild caught deer mice.

Walterson, E., Sangfors, O. and Landner, L. (1994). A collection of results of toxicological evaluation of substances and products. Mono- and Di-Substituted Organotins Used as Plastic Additives. Vol 1 Environmental Hazard Assessment, Swedish National Chemicals Inspectorate, Solna, Sweden. Report no.: KEMI Report No. 11/94.

Result: The acute oral LD50 value reported for rats as between 33 and 300 mg Sn/kg body weight in the KEMI Report.

Nordenhall, K., Dock, L. and Vahter, M. (1994a). Dibutyltin dilaurate. Toxicity Profile. Mono- and Di-Substituted Organotins Used as Plastic Additives. Vol 2 Health Hazard Identification, Swedish National Chemicals Inspectorate, Solna, Sweden. Report no.: KEMI Report No. 11/94.

Nordenhall, K., Dock, L. and Vahter, M. (1994b). Dibutyltin dilaurate. Mono- and Di-Substituted Organotins Used as Plastic Additives. Volume 2 Health Hazard Identification. Swedish National Chemicals Inspectorate, Solna, Sweden. Report no.: KEMI Report No. 11/94.

Sarasin (1981) and Schafer and Bowles (1985) have been allocated a Klimisch score of 2; the other three references are secondary literature and have been allocated a Klimisch score of 4. Sarasin is a study report, whereas Schafer and Bowles is a scientific paper, and so Sarasin, 1981 has been allocated as the key study.

A waiver has been submitted to address the acute toxicity: inhalation endpoint on the basis of lack of exposure.

Acute toxicity via the dermal route was addressed with the study Sanders A (2010). The study was conducted in accordance with the OECD guideline 402 (also EU Method B.3). The study was performed in compliance with GLP. The study was assigned a reliability score of 1 and considered adequate for assessment as a stand alone study. The study was designated as the key study for the acute toxicity endpoint via the dermal route.

Justification for classification or non-classification

In accordance with the directive 67/548/EEC and the regulation (EC) No 1272/2008, the substance does not meet the criteria for classification as acutely toxic.