Shale oils

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12th April - 12th Auguest 2005

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:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Shale oils

EC Number:

269-646-0

EC Name:

Shale oils

Cas Number:

68308-34-9

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Shale oil

Test animals

Species:

rat

Strain:

other: HanRcc:WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, CH-4414, Füllinsdorf / Switzerland
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: 182.3 - 189.6
- Fasting period before study: 17 - 19 hours. Access to water was permitted.
- Housing: in groups of 3 in Makrolon type 4 cages
- Diet (e.g. ad libitum): ad libitum, pelleted diet
- Water (e.g. ad libitum): ad libitum, community tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period

IN-LIFE DATES: From: 12th April 2005 To: 5th May 2005

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
No vehicle used

MAXIMUM DOSE VOLUME APPLIED: 200 mg/kg bw

DOSAGE PREPARATION (if unusual): Homogeneity of the test substance was maintained during administration using a magnetic stirrer.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit dose for classification via the oral route.

Doses:

2000 mg/kg bw (2.04 mL/kg bw)

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 21 days
- Frequency of observations and weighing:
Mortality / Viability Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
Body weights On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Statistics:

No statistical analysis performed

Results and discussion

Preliminary study:

NDA

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Slightly ruffled fur was observed in all animals of the first-treated group from the 2-hour reading to the 5-hour observation and persisted in one animal up to the examination on test day 2. In the animals from the second-treated group, this symptom was o

Gross pathology:

Congestion of the lungs in one animal. No findings in other animals

Other findings:

NDA

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria

Conclusions:

The median lethal dose of Shale oil after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight

Executive summary:

In an acute toxic class experiment in accordance with OECD 423 and EU method B.1, performed to GLP standard, 6 female HanRcc:WIST (SPF) rats were given a single 2000 mg/kg bw dose of shale oils middle fraction.

The median lethal dose of Shale oil after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight