Shale oils, light

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5th March - 14th April 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Shale oils, light

EC Number:

923-592-0

Molecular formula:

Not applicable. A generic molecular formula cannot be assigned to this UVCB substance.

IUPAC Name:

Shale oils, light

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Accredited Breeding Velaz, Prague, Czech Republic
- Age at study initiation: NDA
- Weight at study initiation: Males 175 - 190 g, females 150 - 155 g
- Fasting period before study: overnight prior to study
- Housing: Animals were housed 3 to a cage with wooden grate bedding and in conformity with animal welfare legislation.
- Diet (e.g. ad libitum): A standard certified laboratory diet was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 18th March 2010 To: 7th April 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: NDA
- Lot/batch no. (if required): L 812160
- Purity: NDA

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

DOSAGE PREPARATION (if unusual): Test article was mixed with vehicle shortly before administration. Required amount of test article was weighed out and mixed with precise amount of vehicle shortly before application.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (3 male/3 female) animals per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed:
- Clinical signs:
Animals were observed individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours and daily thereafter, for a total of 14 days. Duration of observation was considered sufficient. All observations are systemically recorded. Clinical signs and conditions associated with pain, suffering and impending death, are described in detail in a separate OECD Guidance Document. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor qactivity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy sleep and coma.

- Body weight:
Individual weights of animals were determined shortly before the test article was administered and weekly thereafter. Weights of animals were recorded at the end of the study. Weight changes after first and second weeks after application were calculated and recorded.

- Pathology:
After finishing of observation period, the animals were sacrificed by exsanguinations in ether narcoses. The necropsies were made by standard operation procedures. All tested animals were subjected to a full, detailed gross necropsy, which included carful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes will be recorded for each animal.

Statistics:

NDA

Results and discussion

Preliminary study:

NDA

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None observed

Clinical signs:

other: None observed

Gross pathology:

One male had an enlarged spleen with an uneven surface. One female was found with an uneven surface on the spleen. No other effect were found.

Other findings:

NDA.

Any other information on results incl. tables

Table 1: Body weight changes

Cage No.	Sex	Animal No.	B.W. initial [g]	Applied volume [ml]	Response	After 1 week		After 2 weeks
						B.W. [g]	B.W. change [g]	B.W. [g]	B.W. change [g]
3	Females	1	150	1.50	0	150	0	170	20
		2	155	1.55	0	150	-5	155	5
		3	155	1.55	0	170	15	185	15
4	Males	4	175	1.75	0	180	5	225	45
		5	180	1.80	0	200	20	250	50
		6	190	1.90	0	210	20	255	45

Response: 0 - surviving

X - death

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 to male and female rats was > 2000 mg/kg bw, It can be concluded that product Shale oils, light is not toxic after single oral administration and is therefore not classified according to the EU CLP criteria.

Executive summary:

Shale oils, light fraction was dosed orally via gavage to 3 female (150 - 155 g) and 3 male (175 - 190 g) wistar rats at limit dose of 2000 mg/kg, in accordance with OECD 423 and performed to GLP. Neither death nor visible symptoms of toxicity during 14 day observation period were seen. It can be concluded that product Shale oils, light is not toxic after single oral administration and is therefore not classified according to the EU CLP criteria.