Registration Dossier

Administrative data

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
18.2 mg/l (mean value, sd 2.80)
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
> 18.2 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
Zero
Clinical signs:
Some signs attributed to the restraints. In addition, increased respiratory rates during and one hour after exposure. After one day animal had hunched posture, increased respiratory rates and in one case strained head (unclear if these are restraint related). All appeared normal after three days.
Body weight:
Variations not considered significant.
Other findings:
Dark patches observed on the lungs of females during necropsy.

Applicant's summary and conclusion

Conclusions:
It is considered reasonable that ... [the substancer] does not meet the criteria for classification and will not require labelling for inhalation toxicity.