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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
Read Across to Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) (EC Number 248-227-6 and CAS No 27107-89-7) based on structural similarity and hydrolytical behaviour, see attached justification.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
6 December 2011 to 24 Juanuary 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
other: read-across target
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
- Acclimatisation: 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
- Photopeiod: 12 hours light / 12 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.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle:B ecause the test substance is a liquid and considered non corrosive , the 2000 mg/kg body weight anaimls 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. and 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
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.
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:
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 animals within the first day after dosing.
At 50 and 300 mg/kg, no clinical sings were observed during the 14- day study period.
Body weight:
All surviving animals at all dose-levels gained weight at all dose-levels.
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
Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
Under the conditions of this study, the oral LD50 value in female Sprague-Dawley rats was established to exceed 2000 mg/kg body weight.
Executive summary:

A sample of the test material was examined for acute oral toxicity in an experiment with female rats (limit testing), according to EC Directive 96/54/EEC, method B.1 tris and OECD Guideline no.423, under GLP conditions.

Dose levels of 2000, 300 and 50 mg 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/ bw dose-levels. The 2000 mg/kg bw 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 the test material is considered to be between 2000 and 5000 mg/kg/day.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Triisooctyl 2,2',2''-[(octylstannylidyne)tris(thio)]triacetate
EC Number:
247-665-5
EC Name:
Triisooctyl 2,2',2''-[(octylstannylidyne)tris(thio)]triacetate
Cas Number:
26401-86-5
Molecular formula:
C38H74O6S3Sn
IUPAC Name:
Triisooctyl 2,2',2''-[(octylstannylidyne)tris(thio)]triacetate

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

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