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Administrative data

Description of key information

The following key studies were submitted to fulfil the acute toxicity data requirement:
Oral:
In an acute oral toxicity study equivalent to OECD Guideline No. 401, groups of 10 young adult Sprague-Dawley rats/sex were given a single oral dose of the test item Prosper MSL (96 % Methyl-(Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oat) in vegetable oil at doses of 0 (vehicle control), 100, 200, 400, 800, and 1600 mg/kg bw and observed for 14 days.
Oral LD50 Females: 419 mg/kg bw (95% C.L. 229.78 to 764.46 mg/kg bw)
Oral LD50 Males: 526 mg/kg bw (95% C.L. 319.59 to 866.74 mg/kg bw)
Treatment related clinical signs were lethargy, motor incoordination, altered faeces consistency, nosebleeding and body weight retardation. There were no treatment related necropsy findings in animals found dead within the observation period or sacrificed at study termination.
Methyl-(Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oat is of moderate toxicity based on the oral LD50 of 526 and 419 mg/kg bw in male and female rats, respectively.
Dermal:
The acute dermal LD50 of the test material is in the range of 5000 mg/kg bw, as within one week of observation 3/5 males and 2/5 females died after application of this dose, whereas none of the animals treated with 2500 mg/kg bw . The whole treated area of the skin became necrotic and started to slough off seven days after the application of the test material. To avoid unnecessary suffering the experiment was therefore terminated after one instead of two weeks. After treatment a heavy weight loss was also observed.
Inhalation: As the substance is known to be corrosive to the skin, it is considered justified to omit further testing in the interest of animal welfare.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Oral:

The Manzo, 1991 study is considered to be the key endpoint for acute oral toxicity as the study seems comparable to the OECD 401 guideline study with acceptable restrictions, however there is no data regarding GLP and has therefore been assigned a Klimisch score of 2. This study is the most recent study available and is also gives the lowest LD50 of the studies and so has been used for classification purposes.

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

Males: 526 (319.59 to 866.74) mg/kg bw

Females: 419 (229.78 to 764.46) mg/kg bw

Supporting information is also available from a summary report for oral toxicity (Davies & Lloyd, 1975). This has been assigned a Klimisch rating of 4 as this is a summary report with very limited information on methods, also there are no deatil regarding purity and it predates GLP.

Result: LD50 1.0 ml/kg (equivalent to 1380 mg/kg)

Dermal:

The Sarasin, 1981 study is considered to be the key endpoint for acute dermal toxicity as the study seems comparable to guideline study with acceptable restrictions, however there is no data regarding purity and GLP and has therefore been assigned a Klimisch score of 2.

Inhalation: As the substance is known to be corrosive to the skin, it is considered justified to omit further testing in the interest of animal welfare.

Justification for classification or non-classification

Oral:

According to the criteria set out in Directive 67/548/EEC, the test material is classified with R22; Harmful if swallowed, and as Acute Category 4; H302: Harmful if swallowed, according to Regulation (EC) No 1272/2008.

Dermal:

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

Inhalation: Further testing for this endpoint is considered uneccessary, as the substance is classified as corrosive.