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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:
27.7.-11.8.2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Fluidized Bed Combustion (FBC) Bottom Ash
- Substance type: technical product
- Physical state: solid
- Chemical structure: Complex product of oxides
- Main components: SiO2 - 27,78%, Fe2O3 - 5,98%, CaO (total) - 35,65%, Na2O - 0,25%, P2O5 - 0,38%, CO2 - 0,5%, CaO (free) - 19,91%, Al2O3 - 11,16%, TiO2 - 2,65%, MgO - 0,44%, K2O - 0,42%, SO3 (sulphate) - 2,84%
- Impurities: Metals: As, Be, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Tl, V, Zn - sum < 0,1%
- Lot/batch No.: FBC/230309/T2
- Expiration date of the lot/batch: 03/2024
- Stability under test conditions: stable
- Appearance: Light grey solid powder with some small black particle
- Storage: The substance was stored in PE container at room temperature.
- pH: Approximately 11 (by contact of application form with universal indicator pH strip moistened with water

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Sex: females
- Age: 8-10 weeks at the time application
- Acclimatisation: 5 days
- Total number: 6 females
- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage
- Diet: ST 1 BERGMAN – standard pelleted diet ad libitum
- Water: drinking tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22 +/- 3°C, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): light period 12-hour light/12 hour dark

STUDY TIME SCHEDULE
Animal supply: 22. 7. 2009
Experimental part of study: 27. 7. - 11. 8. 2009

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
PREPARATION OF THE APPLICATION FORM
Immediately before application the test substance was weighed, mixed in vehicle (olive oil) and resulting suspension was administered to the stomach by tube. The single volume of administered suspension was 1ml/100 g of animal body weight.

VEHICLE
Olive oil – Oleum olivae
Batch No.: L803142
Expiration.: 09/2009

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

CLASS METHOD
- Rationale for the selection of the starting dose: according to the methology. Testing schedule (according to EU Method B.1 tris Annex 1D)
START: 2000 mg/kg – 3 females (Step No.1): no deaths ► 2000 mg/kg – 3 females (Step No. 2): no deaths ► END of study
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 females (Step No.1: 3 females, Step No.2: 3 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Body weight: before application, the 8th day and before euthanasia of animals
- Mortality: daily
- Clinical examination: daily (After application the animals were observed individually: The first day: twice (30 minutes and 3 hours after application), the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days). Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
- Pathological examination: All test animals survived to the end of study were sacrificed on the 15th day by prolonged ether narcosis and gross necropsy was carried out. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died during the study.
Clinical signs:
No clinical signs of intoxication were detected after application in all animals. Clinical signs of intoxication (piloerection) were observed in all six animals at the 3 hours after application only.
Body weight:
Weight increments were adequate to species, sex and age of animals in experiment.
Gross pathology:
The test substance caused no pathological changes in all animals from both groups.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Evaluation of results
The test substance toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study.
The test substance administered at the dose of 2000 mg/kg caused no death of animals. Clinical signs of intoxication (piloerection) were observed in all six animals at the 3 hours after application only. No pathologic macroscopic changes were diagnosed during pathological examination in all animals.

Test substance toxicity characterization
According to the study results the value of LD50 of the test substance, Fluidized Bed Combustion (FBC) Bottom Ash, (in female rats) is higher than 2000 mg/kg of body weight.
Executive summary:

The aim of the study was to investigate acute toxic effects of the test substance, Fluidized Bed Combustion (FBC) Bottom Ash, after a single oral administration to Wistar rats.

 

The testing was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

 

The test substance was administered in a single dose as solution in vehicle (olive oil), given orally via gavage to two groups of three female Wistar rats.

 

The dosing was performed sequentially in two groups of three females: group No. 1 - first step using the starting dose of 2000 mg/kg of body weight and group No.2 - second step using the same dose.

               

The test substance administered at the dose of 2000 mg/kg caused no death of animals. Clinical signs of intoxication (piloerection) were observed in all six animals at the 3 hours after application only.

No pathologic macroscopic changes were diagnosed during pathological examination in all animals

     

According to the study results the value of LD50 of the test substance for female rats is higher than 2000 mg/kg of body weight.

 

The classification of the test substance toxicity was performed according to the Directive 67/548/EEC, Annex VI. part 3.1.5. and 3.2.

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test substance Fluidized Bed Combustion (FBC) Bottom Ash did not fall into any of quoted categories of toxicity and has no obligatory labelling requirement in this respect.