Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TNT 99.95% purity.
The test item, 2,4,6-Trinitrotoluene was administered following sieving and grinding. The test item was sieved and ground by mortar and pestle (to allow a viable aerosol to be produced), and stored at ambient conditions until use.

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
no
Remarks:
The carrier air into the exposure chamber and the extraction from it was monitored visually using calibrated flow meters and recorded at approximately 30 minute intervals throughout the exposure period.
Duration of exposure:
4 h
Concentrations:
The target concentration of 1.0 mg/L was selected based on the known oral toxicity (LD50) of 2,4,6-Trinitrotoluene.
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.01 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
There was no mortality observed during the study period.
Clinical signs:
other: Slow respiration, salivation and red liquid apparent in restraint tube were noted in all animals during the 4 hour exposure. Subdued behaviour, laboured respiration, rolling gait, piloerection, unkempt coat, and red staining, abdomen were noted post expos
Body weight:
All animals’ body weight profile was satisfactory throughout the study period
Gross pathology:
No necropsy findings were noted in any animal

Any other information on results incl. tables

The following parameters and end points were evaluated in this study: clinical signs, body weights, body weight changes, and gross necropsy findings.

In conclusion, following a single 4 hour inhalation exposure to 2,4,6-Trinitrotoluene via snout only method no mortality or overt toxicity was observed during exposure or post exposure observation period. The LC50 is considered to be in excess of 1.01 mg/L.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, following a single 4 hour inhalation exposure to 2,4,6-Trinitrotoluene via snout only method no mortality or overt toxicity was observed during exposure or post exposure observation period. The LC50 is considered to be in excess of 1.01 mg/L.