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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study: meets scientific standards with acceptable restrictions (limited number of animals in study, partly limited documentation)

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Study from 1972 (no guidelines available at the time the study was performed).
Deviations:
not applicable
Principles of method if other than guideline:
6 mature male rats were placed in a stainless steel chamber of 35 L capacity and exposed for 6 hrs to a concentrated atmosphere of vapours produced by passing a stream of air through 81.3 g of the TS contained in a 250 mL Erlenmeyer flask. Vapours from the flask passed into a one L bottle to remove droplets and then into the chamber. Air flow through the sample was 4 L per minute as measured by a calibrated rotameter. This was sufficient to violently agitate the liquid. No supplementary air was introduced inasmuch as the above supply was ample for the animals oxygen requirements.
The animals were observed for behaviour during exposure and for 10 days following exposure. The viscera of the test animals were examined macroscopically.
GLP compliance:
no
Remarks:
Study from 1972 (GLP was not compulsory at the time the study was performed).
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/batch No.: 68 T 1
crude test substance (no further data)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
6 mature SD rats in study.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Details on inhalation exposure:
Average temperature inside chamber: 74 degrees F
Average relative humidity inside chamber: 62 %

Amount of sample:
To start: 81.3 g
Recovered: 48.5 g
Total vaporised: 32.8 g (40.34 %)
Recovered from condenser: 0.0 g (0.0 %)
Weight of vapours entering chamber: 32.8 g (40.34 %)
Average concentration of vapours in chamber: 22.85 mg/L

The animals were observed for behaviour during exposure and for 10 days following exposure. The viscera of the test animals were examined macroscopically.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
6 h
Concentrations:
22.85 mg/L
No. of animals per sex per dose:
6 m
Control animals:
not specified
Statistics:
No data.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
ca. 22.85 mg/L air
Based on:
other: average concentration of vapours in chamber
Exp. duration:
6 h
Remarks on result:
other: LC50 not reported, as individual data on mortality were given
Mortality:
All animals survived the 6 hrs exposure period. 3 animals succumbed within 48 hrs after start of the exposure (42 hrs following 6 hrs exposure period) and 3 animals survived the 10 day observation period.
Clinical signs:
Observations during exposure:
immediate: slight discomfort
30 min: reflexes slow, slight ocular discharge
2 hrs: great lethargy (near collapse)
3 hrs: all collapsed; rapid respiration
4 hrs: all collapsed; shallow respiration
6 hrs: all collapsed; shallow respiration; roughened fur (bodies wet)

Observations following exposure:
All animals were in state of collapse when removed from the chamber, shallow respiration bodies wet.
1 h: 5 animals collapsed, one moved about with great lethargy
18 hrs: 2 animals dead, 1 collapsed, 3 lethargic
24 hrs: 2 animals dead, 1 collapsed, 2 lethargic, 1 with near normal movement
48 hrs: 3 animals dead, 3 normal or near normal
10 days: survivors appeared normal with normal weight gain.
Body weight:
Survivors: normal weight gain 10 days after exposure.
Gross pathology:
Necropsy of survivors: slight congestion of lungs.
Necropsy of died animals: haemorrhagic lungs, slight liver discoloration, acute GI inflammation.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
3/6 male rats died within 48 hrs after exposure to ca. 22.85 mg/L over 6 hrs.
Executive summary:

In this older study 6 male SD rats were exposed to a concentration of ca. 22.85 mg/L over 6 hrs. 3/6 animals died within 48 hrs after exposure and toxic signs included lethargy and collapse. After 10 days survivors appeared normal with normal weight gain. The necropsy of survivors showed slight congestion of lungs, while necropsy of died animals showed haemorrhagic lungs, slight liver discoloration, and acute GI inflammation.