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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: no purity of test article; test atmosphere generation method lacked adequate details; no particle size distribution; no method for calculation of test atmosphere concentration; incorrect classification based on guideline cited.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Principles of method if other than guideline:
Reference was made to the Federal Hazardous Substances Act.

The group of 10 rats was placed in a sealed 59.1 liter glass
chamber and exposed for 4 hours to a dynamic atmosphere containing the
dust of the test material.

During the 4 hour exposure to the test compound, the rats were
observed continuously for changes in behavior and/or appearance.
Immediately following the exposure, the rats were examined closely for
pharmacodynamic and/or toxic signs. All rats which died on study were
subjected to a gross necropsy examination. The rats were observed for
a period of 14 days and then sacrificed.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Dilauroyl peroxide
EC Number:
203-326-3
EC Name:
Dilauroyl peroxide
Cas Number:
105-74-8
Molecular formula:
C24H46O4
IUPAC Name:
dodecanoyl dodecaneperoxoate
Details on test material:
Test substance only identified as lauroyl peroxide composite toxicity sample

Test animals

Species:
rat
Strain:
other: Spartan
Sex:
male
Details on test animals or test system and environmental conditions:
None provided

Administration / exposure

Route of administration:
inhalation: dust
Details on inhalation exposure:
Addition of the test compound to the test chamber atmosphere
was controlled by two Wright Dust Feeders. Dried and filtered air was
passed through the mechanism and directly into the exposure chamber.
Airflow was regulated by means of flowmeters.



Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
The calculated atmospheric concentration administered was
approximately 200 mg/L of Lauroyl Peroxide, 13-3974-4.
No. of animals per sex per dose:
10
Details on study design:
Ten male rats of the Spartan strain, weighing from 200 to 238
grams, were used in this test. The rats were housed in groups of 5
in metal cages above the droppings and maintained in temperature and
humidity controlled quarters throughout the pre-exposure and postexposure
periods. Purina Laboratory Chow and water were available
ad libitum.
During the 4 hour exposure to the test compound, the rats were
observed continuously for changes in behavior and/or appearance.
Immediately following the exposure, the rats were examined closely for
pharmacodynamic and/or toxic signs. All rats which died on study were
subjected to a gross necropsy examination. The rats were observed for
a period of 14 days and then sacrificed.
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: mortality at the maximum test atmosphere concentration
Effect level:
ca. 200 mg/L air (nominal)
Based on:
not specified
Exp. duration:
4 h
Remarks on result:
other: An LC50 was not determined
Mortality:
Six of the ten rats died.
Clinical signs:
other: Signs seen during the 4 hour exposure period included the following: eye squint, dyspnea, increased and decreased respiratory rates, erythema, salivation, lacrimation and an increased followed by a decreased motor activity. At 24 hours following compound
Body weight:
Not reported
Gross pathology:
Necropsy findings in the 4 rats which died during the first
24 hours post-exposure included mild focal thymic hemorrhage,
moderate to severe petechiation of the lung, moderate congestion of
the liver and heart, and corneal opacity and vascularization. One
rat which died during this period had severe focal hemorrhage of the
right kidney. The rat which was found dead 48 hours post-exposure
had severe thymic hemorrhage, bright red lungs, moderate congestion
of the liver, and a large quantity of gas in the stomach. The rat
found dead on the 7th day had multiple focal hemorrhages of the lungs
and thymus, moderate congestion of the liver and slight bilateral
hydronephrosis.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Six of ten rats died when exposed for 4 hours to an atmosphere of dust containing a calculated atmospheric concentration of 200 mg/l.
Executive summary:

A composite sample of lauroyl peroxide was evaluated in rats for acute inhalation toxicity following a 4 hour exposure to an atmosphere containing 200 mg/l of dust.

The 4 -hr acute inhalaton toxicity of Laurox was evaluated by generation of a dry aerosol using a Wright dust feeder. The concentration was calculated to be 200 mg/l which is an exteremly high concentration for a dry aerosol. Although the actual concentration and particle size are not known, this sudy demonstrates that at high dust concentration (exceeding the limit concentration of current guidelines) there was 60% mortality and that inhalation toxicity is expected to be low.