Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 269-646-0 | CAS number: 68308-34-9 The complex combination of hydrocarbons obtained by the thermal decomposition (at 399°C (750°F) or higher) of kerogen. It consists of hydrocarbons and heterocyclic compounds containing nitrogen, sulfur or oxygen.
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:
- 2 005
- 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
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
