Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Some information in this page has been claimed confidential.

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
The study was conducted in accordance with the following guidelines: ASTM E981-04, Standard Test Method for estimating sensory irritancy of airborne chemicals; with regard to the technical conduct of the study.
The OECD Guideline for the Testing of Chemicals 403, Acute inhalation toxicity, adopted 12 May 1981; with regard to the treatment of the animals.
Test type:
other: The objective of this study in rats was to provide data on the sensory irritation by means of the Alarie test in Wistar rats.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
other: RD50
Effect level:
4.25 mg/L air
Exp. duration:
30 min

Any other information on results incl. tables

Exposure to the test material at all concentrations resulted in a change in breathing pattern characterized by an irregular breathing pattern. These consisted of normal breathing intermingled with periods of irregular breathing. However, post-inspiratory apnoeas, characteristic for sensory irritation, were only observed in one out of four animals exposed to 2.86 mg/L and in two out of four animals exposed to 4.25 mg/L. Clinical signs were not seen during the 7-day post-exposure period. Mean body weight gain was low from day 0 to day 3, whereas from day 3 to day 7 body weight gain was considered to be within a normal range for animals of this strain and age. Absolute and relative lung weights of the exposed animals were considered to be normal for animals of this strain and age. Abnormalities were not observed at necropsy 7 days after exposure.

Overall, the results of this study show sensory irritation to be present in rats at levels of 2.86 and 4.25 mg/L NTA. The RD50 value was estimated to be close to 4.25 mg/L. Although there was high inter-individual variability in responses amongst the rats, these results suggest that sensory irritation is confined to high exposure levels, close to the technically highest attainable concentration. Sensory irritation was absent at a level of 0.91 mg/L NTA.

Applicant's summary and conclusion