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EC number: 930-690-7
CAS number: -
The LD50 to male and female rats was >2000 mg/kg bw, It can be concluded that product Shale oils, heavy is not toxic after single oral administration and belongs to class 5 (unclassified) according to GHS.The median lethal dose of Shale oil after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight (this result is read-across from Shale oil, middle fraction).The median lethal dose of Generator oil after 2 hours exposure to white mice, observed over a period of 14 days was 19 mg/L.
Table 1: Body weight changes
After 1 week
After 2 weeks
Response: 0 - surviving
X - death
Shale oils, heavy fraction was dosed orally via gavage to 3 female (120
- 140 g) and 3 male (145 - 160 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, heavy is not toxic
after single oral administration and belongs to class 5 (unclassified)
according to GHS.
The influence of volatile compounds of generator oil the activity of the
movement and irritation of mucosa was observed already at the
concentration of 0.18 - 0.25 mg/l. Increasing the concentration of
volatile compounds in the chamber up to 5.9 ml/l the mice looked tired
(sluggish) during the test and 30 min after the test. In some cases
during the second hour of the test dyspnoea was observed. At higher
concentrations (10-12 ml/l) in addition to tiredness and dyspnoea,
during the second hour of the test the redness of nose, ears and paws
Increasing the concentration of the volatile compounds up to 29 ml/l and
higher during the second hour of the test additionally to lower movement
activity, interruptions in movement coordination and dyspnoea in mice
ballisms (mostly of the head and paws) were observed; after 10 , 15 and
20 minutes they lost the ability to stand on their feet (took side
position). Afterwards the intoxicative appearance and strengthening of
spasms was observed. Before death the convulsions gradually stopped.
Animals died when breathing progressively weakened. In few cases death
came 2-3 days after the test.
In autopsy of white mice, stagnation phenomenon in brain and lungs were
observed. Quite often macroscopic signs of degenerative changes in liver
First signs of intoxication with volatile compounds of generator oil in
white mice were observed at concentrations of 0,25 mg/l. The main
parameters of toxicity to white mice were as follows: LC0 =
13 mg/l, LC100 = 30 mg/l, LC50 = 19 ± 1.4 mg/l.
As described before we can see that intoxication with volatile compound
of generator oil are characterized with the same symptoms as of
intoxication with other substances. These kind of symptoms as change in
the character of breathing, disorder of movement coordination, cramps,
lying on the side etc. are also signs of intoxication with organic
solvents; redness of nose, ears and paws are observed in case of
intoxication with toluene; head and paw cramps indicate impact of
White mice were exposed to generator oil in an aerosol inhalation
experiment for 2 hours.
The LC50 of generator oil to white mice was 19 ± 1.4 mg/L.
Five male and five female HanRcc:WIST (SPF) rats were treated with Shale
oil at 2000 mg/kg by dermal application in accordance with OECD 402 and
to GLP standard. The test item was applied undiluted as delivered from
the sponsor at a volume dosage of 2.04 mL/kg. The application period was
No mortality, clinical signs or abnormal body weight changes were
observed. Mild to moderate skin irritation effects were observed in all
The median lethal dose of Shale oil after single dermal administration
to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight.
Based on the rationale for read-across, it is considered acceptable to
use this study to address the same endpoint for heavy fraction of shale
Key value for chemical safety assessment
Acute toxicity: oral
Effect level LD50 in mg/kg bw >2000
Acute toxicity: dermal
Acute toxicity: inhalation
Effect level LC50 in mg/m3 = 19000
For both the heavy and middle fractions of shale oil, the acute oral
LD50 was found to be >2000 mg/kg bw, and both were found not to induce
gene mutations in a bacterial reverse mutation assay (AMES test) without
and with metabolic activation. This demonstrates that the toxicologcial
profile of the two fractions is similar. This, combined with analytical
data which showed the two fractions to be compositionally similar,
supports the validity of a read-across approach to address the acute
dermal toxicity endpoint. Hence, the study conducted on the middle
fraction of shale oil, is considered robust enough to be the key study
for the heavy fraction.
Due to the physical and chemical similarity of generator oil to shale
oils, it was considered acceptable to use a read across approach in
order to address the acute inhalation toxicity endpoint.
Based upon the high LD50 values for oral, inhalation and dermal exposure, and the absence of other major significant effects, the test substance does not need to be classified for acute toxicity according to Regulation (EC) No 1272/2008. However, to take account of the potential variability in the composition of the UVCB starting material, and the potential variation in the composition of the UVCB substance in scope of this registration, the worst case classification of H301 (Toxic if swallowed), H311 (Toxic in contact with skin), H332 (Harmful if inhaled) and H304 (May be fatal if swallowed and enters airways) is applied.
For further information, please refer to the document 'Shale oils RAAF Report' as included in section 13.
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.
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