Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2009-07-22 to 2009-08-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (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 (as cited in study report): Fluidized Bed Combustion (FBC) Fly Ash
- Physical state: Light grey solid powder
- Lot/batch No.: FBC/230309/T1
- Expiration date of the lot/batch: 15 years/ 03/2024
- Storage condition of test material: The substance will be stored in PE container at room temperature.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republik
- Age at study initiation: 8-10 weeks
- Fasting period before study: 24 hours
- Housing: in groups of 3 animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 1 mL/100 g bw
- Justification for choice of vehicle: solubility, gavage

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: OECD guideline 423
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
first experiment: 3 animals
second experiment: 3 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations on day 1 and 2 twice and once daily upon study end; weighing before application, on day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: changes in skin and fur, eyes, visible mucous membranes, behavior, somatomotor activity, reactions to stimuli, presence of lacrimation, discharge and salivation from nostrils, function of respiratory, digestive and urogenital system

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occured
Clinical signs:
No clinical signs of intoxication were observed.
Body weight:
No abnormal changes in body weight were reported.
Gross pathology:
No pathologic changes were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU