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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:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Insufficient details provided for methods or for determination of the median lethal concentration to ensure any reliance can be placed on the test results for use in the risk assessment process. However the study findings do confirm the negligible or low potential for adverse effects following possible inhalation exposure to the test substance and therefore support the waiving arguments presented.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A continuing program of generating range-finding toxicity data, followed protocols written in the 1940's, designed to determine effects following single inhalation exposure to rats (the program also include single skin penetration test in rabbits, single oral dosing of rats, dermal irritation in rabbits and corneal damage in rabbit eyes). The methods were refined and last redrafted in 1962. However the details of the methods were not presented with the List VIII findings.
GLP compliance:
no
Test type:
other: range-finding inhalation toxicity test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further details.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
No details of methods provided
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
No data
No. of animals per sex per dose:
No information supplied
Control animals:
not specified
Details on study design:
No details presented in publication
Statistics:
No details

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC50
Exp. duration:
8 h
Remarks on result:
other: The maximum period of exposure resulting in no mortality, when rats were exposed via inhalation to the concentrated vapour, by inhalation was 8 hours.
Mortality:
No mortalities occurred
Clinical signs:
No data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No evidence of inhalation toxicity following acute exposure.
Executive summary:

In a range-finding investigation that was part of an on-going collation of acute study data, the result of a study is presented - no evidence of inhalation toxicity following acute exposure - but insufficient details are provided for methods used.