Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-12-10 - 2005-04-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
, adopted 2001-12-17
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diantimony pentoxide
EC Number:
215-237-7
EC Name:
Diantimony pentoxide
Cas Number:
1314-60-9
Molecular formula:
O5Sb2
IUPAC Name:
diantimony pentoxide

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 143 - 171 g
- Fasting period before study: A period of overnight fasting prior to dosing which continued until approximately three hours after dosing.
- Housing: The animals were housed in groups of up to five during the acclimatisation period in cages that conform to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Porcedures' (Home Office, London, 1989). From the day prior to dosing, the rats were housed in groups of three in similar cages.
- Diet (ad libitum): SQC(E) Rat and Mouse maintenance Diet No 1, from Special Diets Services Ltd, Witham
- Water (ad libitum): Main water
- Acclimation period: 8 to 14 days

All animals were given a clinical inspection for ill health on arrival and a sample was weighed.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Relative humidity: 40 to 70 %
- Air changes: At least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1 % w/v aqueous methyl cellulose
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: The vehicle was chosen because it gave the most satisfactory results in pre-study formulation trials.

MAXIMUM DOSE VOLUME APPLIED: Individual doses (mL) were calcualted using the fasted body weights of the rats on the morning of dosing and the dose volume of 10 mL/kg.

DOSAGE PREPARATION: The test article was dispersed in 1 % w/v aqueous methyl cellulose. The formulated concentrations were calculated from the selected dose level and the dose volume of 10 mL/kg. All formulations were used within two hours of preparation.
The formaultions were maintained on a magnetic stirrer prior to administration to ensure homogeneity.

CLASS METHOD
- Rationale for the selection of the starting dose: Since there were no data to indicate that deaths may occur at dose levels of less than 2000 mg/kg, the first dose level was 2000 mg/kg.
No further information on oral exposure was stated.
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 groups of 3 females each
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were recorded at approximately 15 and 30 minutes post-dose, hourly between 1 and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed one day before dosing and on Days 1 (dosing), 4, 8 and 15.
- Necropsy of survivors performed: Yes; Rats were killed by intraperitoneal injection of sodium pentobarbitone on Day 15. After exsanguination a full macroscopic necropsy was performed and all lesions recorded. The necropsy procedure included inspection of external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines.
No further information onstudy design was stated.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths following a single oral dose of EFR-6N (Diantimony pentoxide) among rats dosed at 2000 mg/kg.
Clinical signs:
No clinical signs were seen.
Body weight:
All rats gained weight during the first and second weeks of the observation period.
Gross pathology:
No marcoscopic changes were observed for animals killed on Day 15.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal oral dose was found to exceed 2000 mg/kg.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified.