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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-07-09 to 1996-07-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

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:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tellurium dioxide
EC Number:
231-193-1
EC Name:
Tellurium dioxide
Cas Number:
7446-07-3
Molecular formula:
O2Te
IUPAC Name:
tellurium dioxide
Constituent 2
Reference substance name:
oxotellan oxide
IUPAC Name:
oxotellan oxide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Tellurium dioxide
- Substance type: inorganic
- Physical state: fine white powder
- Analytical purity: 99.99 %
- Lot/batch No.: 44/2
- Storage condition of test material: at ambient temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 5-6 weeks old upon arrival
- Weight at study initiation:
- Fasting period before study: overneight
- Housing: five animals per cage (stainless steel cages, fitted with wire screen floor and front)
- Diet (e.g. ad libitum): standard laboratory rodent diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): between 60-91 %
- Air changes (per hr): ca 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours Iight/12 hours dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/ kg max. Dose volume

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals/ sex/ dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were made within 1 hour and within 4 hours after dosing, and subsequently at least once daily throughout the observation period of 14 days; body weights were recorded on day 0, 3, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the 14-day observation period.
Clinical signs:
At 4 hours after dosing, all males showed signs of diarrhoea. No other clinical symptoms were observed.
Body weight:
Apart from a slight dip in body weight of one male on day 7, all animals gained weight during the 14-day observation period.
Gross pathology:
Examination of the animals at autopsy did not reveal any treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for tellurium dioxide (powder) was determined to be above 5000mg/kg bw .
Executive summary:

In an acute oral toxicity study according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method), wistar rats were given a single oral dose of tellurium dioxide (powder) in maize oil at a dose of  5000, mg/kg bw (5 animals/sex/ group) and observed for 14 days.

No mortality occurred. At 4 hours after dosing, all males showed signs of diarrhoea. No other clinical symptoms were observed.

Apart from a slight dip in body weight of one male on day 7, all animals gained weight during the 14-day observation period.

Examination of the animals at autopsy did not reveal any treatment-related gross alterations.

Since no mortality occurred during the 14-day observation period, the oral LD50of tellurium dioxide is considered to exceed 5000 mg/kg bw in both male and female rats.