Oil shale, thermal processing waste

Endpoint summary

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:

other: No clinical signs of intoxication were observed.

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.