Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1972
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Reliability non specifiable but in light of the very low acute toxicity of the substance this stuy is taken into account following a weight of evidence approach.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
The test material was heated to 288°C and test animals were exposed to the fumes generated.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 154g (average)
- Housing: individually in stock cages
- Diet: standard laboratory diet, ad libitum
- Water: ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Details on inhalation exposure:
Test animals were exposed in a specially constructed Plexiglas inhalation chamber having a capacity of 700 liters . Each animal was caged separately during exposure to minimize filtration of inspired air by animal fur. The test atmosphere was generated by heating 7.0 g of test material in an aluminum pan on a hot plate (288"C), placed in an empty 700 liter chamber. The resulting fumes and vapors were then drawn into the 700liter chamber containing the test animals. An additional 7 g of the test material was put in the generator at half hour intervals for a four hour period, thus using a total of 56 grams. Air flow rate through the system was 150 L/min. The temperature of the test atmosphere was 32°C and the pressure was 29.71 inches Hg. The concentration of particulates present in the exposure chamber was determined by sampling the test atmosphere in the breathing zone of the animals being exposed. The total weight of particles collected on a glass fiber filter was divided by the total volume of air drawn through the filter during the sampling period. Air flow rate for sampling was regulated by a calibrated limiting orifice. The average concentration, obtained by repeated air sampling, was 110 mg/m3 air.
Duration of exposure:
4 h
Concentrations:
0.11 mg/l
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior exposure and at the end of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 110 mg/m³ air
Mortality:
No mortalities occurred.
Clinical signs:
other: Nountoward behavioral reactions were observed.
Body weight:
There were no adverse body weight effects. The average two-week body weight gain was 73 g which is within the normal range.
Gross pathology:
Gross pathologic examinations revealed moderate lung hyperemia in 50 percent of the test rats. No other gross pathologic alterations were observed in the test animals.

Applicant's summary and conclusion