2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 December 2011-24 Juanuary 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

EC Number:

248-227-6

EC Name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate

Cas Number:

27107-89-7

Molecular formula:

C38H74O6S3Sn

IUPAC Name:

2-ethylhexyl 10-ethyl-4-({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate

Constituent 2

Reference substance name:

Octyltin tris 2ethyl hexylmercaptoacetate (MOTE)

IUPAC Name:

Octyltin tris 2ethyl hexylmercaptoacetate (MOTE)

Test material form:

liquid

Details on test material:

Date of receipt 28.06.2016
Chemical name: Monooctyltin tris(2-ethylhexylmercaptoacetate) MOTE
Purity: 99.3%
Lot No.: ESOC21.341
CAS No.: 27107-89-7
Storage conditions: 2-10 °C in the dark. Air space flushed with nitrogen. The sample was kept away from air and water. The sample was allowed to warm to room temperature before opening the bottle to prevent condensation of moisture into the sample and prevent any moisture condensed on the outside of the flask from dripping into the sample. Brief periods at room temperature up to 1-2 days were considered not to harm the sample. For longer storage (weeks), refrigerated conditions were used to prevent long term thermal degradation.
Expiry date: 15 March 2012
Appearace: clear colour liquid.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Acclimatization: at least 5 days
Caging: a maximum of 6 animals/sex per macrolon cage with sterilized wood shavings (Lignocel) as bedding material, environmental enrichment (Enviro-Dri) and wood black
Identification: ear tattoo
: 12 hours lighU12 hours dark cycle
room temperature : 20-24 °C.
Relative humidity during testing : 45-65%. The upper limit was incidentally up to 83% (not exceeding ca 1-2 hours) because of meteorological circumstances and/or wet cleaning of the room.


Ventilation: ca 10 air changes/hour
Diet/water : standard laboratory diet ad libitum. Each batch of this diet is analysed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results are kept available in the archives. Tap water (N.V. Vitens) ad libitum. Results of routine physical, chemical and microbiological examin­ ation of drinking water as conducted by the supplier are kept available in the archives. The results of diet and water analyses were considered acceptable for this study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Because the test substance is a liquid and considered non corrosive , the 2000 mg/kg body weight animals was recorded.
- Lot/batch no. (if required):ESOC21.341
- Purity: 97.7%

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg for dose-levels of 50 and 300 mg/kg and 1.8 ml/kg body weight for the 2000 mg/kg dose-level.

Doses:

2000 mg/kg, 300 mg/kg, 50 mg/kg.

No. of animals per sex per dose:

6 females at 2000 mg/kg
3 females at 300 mg/kg
3 females at 50 mg/kg.

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days
- Frequency of observations : observation were made 1 hour and within 4 hour after dosing. adn subsequently at least once daily throughout an observation period of 14 days.
- Weighing: the body weight of each animal was recorded just prior to dosing and of surviving animals on day 3, 7 and 14 of the study.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 - < 5 000 mg/kg bw

Mortality:

At 2000 mg/kg/day, one animal was sacrificed prematuraly, this animals shows protrusion of eyes, ataxia, paralysis and an abominal lump on day 1 of the study.
At 50 and 300 mg/kg, No mortality or clinical signs were observed during the 14-day study period.

Clinical signs:

other: At 2000 mg/kg/day (first and second group) clinical signs generally observed consisted of hunching in 4/6 animals within the first two days after dosing. Occasionnaly, ataxia, blephorasm, piloerection and an abdominal lump were observed in one or two ani

Gross pathology:

At 2000 mg/kg dose -level: first and second group: examination at necropsy did not reveal treateent-related gross alterations, other than the animal killed in extremis which schowed a stomach filled with sawdust.
At 300 mg/kg dose-level, examination at necropsy of the animals did not reveal treatment related gross alterations.
At 50 mg/kg dose-level, examination at necropsy of the animals did not reveal treatment-related gross alterations.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Since five out of six animals survived the 2000 mg/kg dose-level, the oral LD50 of octyltin tris (2-ethylexylmercaptoacetate) MOTE is considered to be between 2000 and 5000 mg/kg/day.

Executive summary:

A sample of Octyltintris(2-ethylhexylmercaptoacetate) MOTE was examined for acute oral toxicity in an experiment with female rats (limit testing), according to EC Directive96/54/EEC, method 8.1 trisand OECD Guideline no.423. Dose levels of 2000, 300 and 50mg per kg bodyweight were examined and animals were observed for a maximum of 14 days after dosing.

No mortality or clinical signs were observed after treatment with a 50 and 300 mg/kg/ bwt. dose-levels.

The 2000 mg/kg bwt dose-level caused mortality in one out of the 6 animals dosed. Clinical signs observed consisted of Hunching, ataxia, blepharospasm, protrusion of eyes, piloerection and an abdominal lump.

Macroscopic examination of the surviving animals at the end of the observation period did not reveal any treatment related gross changes.

Since five out of six animals survived the 2000 mg/kg dose-level, the oral LD50 of octyltin tris (2-ethylexylmercaptoacetate) MOTE is considered to be between 2000 and 5000 mg/kg/day.