Registration Dossier

Administrative data

Description of key information

The following studies have been submitted to address the acute toxicity: oral endpoint:
Sarasin G (1982). TK 10422: ACUTE ORAL LD50 IN THE RAT. Testing laboratory: Ciba Geigy Ltd., Basle, Switzerland, GU2 Toxicology. Report no.: 811808. Owner company: Crompton GmbH. Report date: 1982-02-02.
Schafer EW & Bowles WA (1985). Acute Oral Toxicity and Repellency of 933 Chemicals to House and Deer Mice. Arch. Environ. Contam. Toxicol, 14: 111-129.
Sarasin (1982) was allocated a Klimisch score of 2 because the highest dose level (2500 mg/kg bw) exceeded the limit dose (2000 mg/kg bw) in rats and the source and purity of the test material was not reported. Schafer and Bowles (1985) contains insufficient information for assessment and is allocated a Klimisch score of 4. Sarasin (1982) is considered to be the key study for this endpoint.
The following study has been submitted to address the acute toxicity: inhalation endpoint:
Bretz R (1982). Report on acute aerosol inhalation toxicity in the rat of TK-10422. Testing laboratory: Ciba Geigy Ltd., Basle, Switzerland, GU2 Toxicology. Report no.: 81-1811. Owner company: Crompton GmbH. Report date: 1982-02-26.
The study was allocated a Klimisch score of 2 because it is considered to be comparable to a guideline study but the source and purity of the test material were not reported. The study is considered to be the key study for this endpoint.
The following study has been submitted to address the acute toxicity: dermal endpoint:
Sanders A (2010a). Title: CAS No 78-04-6: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT. Testing Laboratory: Harlan Laboratories Ltd, Shardlow Business, London Road, Shardlow, Derbyshire, DE72 2GD, UK. Report No 4100/3380. Owner Company: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160 Brussels, BELGIUM
The study was conducted to GLP and in line with a recognised guideline (OECD 402)
and has been allocated a Klimisch score of 1.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
510 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
317 mg/m³

Acute toxicity: via dermal route

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

Additional information

The following studies have been submitted to address the acute toxicity: oral endpoint:

Sarasin G (1982). TK 10422: ACUTE ORAL LD50 IN THE RAT. Testing laboratory: Ciba Geigy Ltd., Basle, Switzerland, GU2 Toxicology. Report no.: 811808. Owner company: Crompton GmbH. Report date: 1982-02-02.

The acute lethal dose (LD50) and 95% confidence limits for dibutyltin maleate (DBTM) were reported as:

Males: 422 (11 - 932) mg/kg bw

Females: 647 (233 - 1254) mg/kg bw

Both sexes: 510 (263 - 777) mg/kg bw

Schafer EW & Bowles WA (1985). Acute Oral Toxicity and Repellency of 933 Chemicals to House and Deer Mice. Arch. Environ. Contam. Toxicol, 14: 111 -129.

In an acute toxicity study in deer mice the approximate lethal dose (ALD50) was determined and reported as 470 mg/kg bw. The lethal dose reported for a 3-day feeding test (as a 2.0% treatment rate) was reported as >250 mg/kg bw/day.

Sarasin (1982) was allocated a Klimisch score of 2 because the highest dose level (2500 mg/kg) exceeded the limit dose (2000 mg/kg bw) in rats and the source and purity of the test material was not reported. Schafer and Bowles (1985) contains insufficient information for assessment and is allocated a Klimisch score of 4. Sarasin (1982) is considered to be the key study for this endpoint.

The following study has been submitted to address the acute toxicity: dermal endpoint:

Sanders A (2010a). Title: CAS No 78-04-6: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT. Testing Laboratory: Harlan Laboratories Ltd, Shardlow Business, London Road, Shardlow, Derbyshire, DE72 2GD, UK. Report No 4100/3380. Owner Company: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160 Brussels, BELGIUM

In this key study Sanders (2010a), the acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. The study was conducted to GLP and in line with a recognised guideline (OECD 402) a

nd has been allocated a Klimisch score of 1. The study is considered to be the key study for the acute dermal toxicity endpoint.

The following study has been submitted to address the acute toxicity: inhalation endpoint:

Bretz R (1982). Report on acute aerosol inhalation toxicity in the rat of TK-10422. Testing laboratory: Ciba Geigy Ltd., Basle, Switzerland, GU2 Toxicology. Report no.: 81-1811. Owner company: Crompton GmbH. Report date: 1982-02-26.

The study was allocated a Klimisch score of 2 because it is considered to be comparable to a guideline study but the source and purity of the test material were not reported. The study is considered to be the key study for this endpoint.

Justification for classification or non-classification

Based on results of animal studies the substance should be classified under Directive 67/548/EEC with R22 Harmful if swallowed and R23 Toxic by inhalation. Accordingly under Regulation (EC) No 1272/2008 the substance is assigned to Category 4 for acute oral and Category 2 for acute inhalation toxicity (hazard statements: H302 Harmful if swallowed and H330 Fatal if inhaled).