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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
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

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