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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report date:
1966

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Vapour was generated by passing air through 100 ml of liquid test material. Animals were placed in a chamber breathing vapours for 6 hours. The animals were observed for behaviour and, since there were no deaths, were held for 10 days observation.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-methylenebis(cyclohexylamine)
EC Number:
217-168-8
EC Name:
4,4'-methylenebis(cyclohexylamine)
Cas Number:
1761-71-3
Molecular formula:
C13H26N2
IUPAC Name:
4,4'-methylenedicyclohexanamine
Test material form:
other: vapour
Details on test material:
Manufactured by Monsanto. No information on purity.

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMAL
male rats

ENVIRONMENTAL CONDITIONS
-average temperature inside chamber: 77 °F
-average relative humidity inside chamber: 57 %

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
Four mature male rats were placed in a metal chamber of 35 liters capacity and exposed for six hours to a concentrated atmosphere of vapors produced by passing a stream of air through 100 mL of the compund contained in a 250 mL Erlenmeyer flask. Vapors from the flask passed into a one liter bottle to remove droplets and then into the chamber. Air flow through the sample was 4 L/ min as measured by a calibrated rotameter. This was sufficient to violently agitate the liquid. No supplementaty air was introduced in as much as the above supply was sufficiend for the animals oxygen requirements.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
6 h
Concentrations:
0.4% vapourized or left in equipment
No. of animals per sex per dose:
4 males
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC0
Effect level:
0.4 other: %
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: no quantitative data given on concentration
Mortality:
No deaths occurred under the conditions of the study
Clinical signs:
other: during exposure: mild infammation of the nasal mucose, moderate lethargy and some discomfort, changed brathing rate; after exposure: appetite and activity were practically normal after 24 h, no observations in the 10 day oberservation period
Body weight:
no data
Gross pathology:
mild inflammation of the nasal mucosa

Applicant's summary and conclusion

Conclusions:
A limit acute inhalation toxicity test was conducted in a whole body protocol using male rats with 0.4% 4-4’-methylenedicyclohexanamine. None of the rats died during the 6 hour exposure or 10 days afterwards.
Executive summary:

In a vapour inhalation study with male rats all rats survived the 4 hours exposure as well as the following 10 day observation period. Clinical signs were moderate lethargy and some signs of discomfort. The breathing rate was little changed. Appetite and activity were practically normal in twenty four hours after expsoure. The nasal mucosa showed a mild inflammation. It was concluded that the vapour was sligthly toxic under conditions of the test.