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Description of key information

Burnt oil shale is non toxic via the oral route 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to guideline
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
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system 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

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
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.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study from a reference substance with similar structure and intrinsic properties. Read-across is justified based on similarities in PC/TOX properties. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral route:

An acute oral toxicity study has been conducted with the read across substance Fluidized Bed Combustion (FBC) Fly Ash according to OECD guideline 423 on female Wistar rats (Rösslerova, 2010). 6 animals were exposed to 2000 mg/kg bw of the test substance by gavage in two independent experiments. In the 14 day observation period no deaths occurred and no abnormal clinical signs were reported. Additionally no abnormal body weight changes and no pathological findings were observed.

Inhalation route:

This endpoint has been waived because of the irritating properties of the powder fractions of BOS (P.1034 and P.1082) and the large particle size of the granule fraction of BOS (P.1125 and P.1183).

 

Dermal route:

This endpoint has been waived, because dermal exposition is not the likely route of exposure.


Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

Burnt Oil Shale (BOS) has not to be classified for acute toxicity. Because of the expected irritating potential to mucosal tissue a precaution classification of R37/ STOT SE Cat.3 is recommended for the dusty specifications of BOS, P.1034 and P.1082.

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