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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 403: pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
fixed concentration procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MRD-78-48
- Physical state: liquid

Test animals

Species:
other: mouse, rat and guinea pig were tested
Strain:
other: Swiss-Webster mice, Sprague Dawley rats, and Hartley guinea pigs
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Housing: 5 per cage
- Diet (e.g. ad libitum): Purina cubed diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: closed chamber
- Exposure chamber volume: 100 l
- Method of holding animals in test chamber: Plexiglass chamber
- Source and rate of air: 30 l/min
- Method of conditioning air: Dried, filtered and preheated
- System of generating particulates/aerosols: three-necked flask immersed in a heated water bath and bubbled with air
- Treatment of exhaust air: Fume hood
- Temperature, humidity, pressure in air chamber: room temp
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 6 h
Concentrations:
Exposure concentration was determined on a nominal basis only and was calculated by dividing the net weight of compound used during the 6 h experiment by the total air flow through the chamber during the espoure. The nominal concentration was computed to be 24 ug/l.
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
No data was analyzed

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 0.024 mg/L air (nominal)
Exp. duration:
6 h
Remarks on result:
other: For mice, rats, and guinea pigs
Mortality:
0%
Body weight:
The exposed animals appeared to gain weight normally during the observation period.
Gross pathology:
Lungs were observed to be grayish or marked by gray and red foci. There were moderate incidences of mottled livers and kidneys.
Other findings:
As the experiment progressed, most mice became quiet, went to sleep or were mildly sedated. Respiration in some of the rats and guinea pigs appeared to be slightly labored. All signs of depressed physiological function were resolved upon moving the animals to fresh air.

Applicant's summary and conclusion

Interpretation of results:
other: not classifiable
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
This data can not be used for classification purposes.
Executive summary:

In this study, groups of male mice, rats and guinea pigs were subjected to a whole body exposure of a nominal concentration of 24 ug/l of isooctanol as a saturated vapor for 6 hours. All animals survived the study. There were indications of depressed physiological function in all animals; indicated by sedation and labored breathing. These observations were resolved once the animals were moved into fresh air. From this study, it is concluded that the LC50 is greater than 0.024 mg/l as a 6 hour exposure.