Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according EU/OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0, 35, 447 and 5969 mg/m³ air.
No. of animals per sex per dose:
five male and five female animals per test group
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LC50
Effect level:
> 5 969 mg/m³ air (analytical)
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
> 5 969 mg/m³ air (analytical)
Exp. duration:
4 h

Any other information on results incl. tables

Clinical signs

A complete listing of the intensity and time-dependence of the observed signs is presented in

the Appendix. A qualitative description, for the signs of importance in toxicological evaluation,

is given below.

Groups 0 and 35 mg/m³ air: No signs observed.

Group 447 mg/m³ air: Piloerection, bradypnea.

Group 5969 mg/m³ air: Reduced motility, piloerection, ungroomed coat, bradypnea, labored breathing, staggering and high-stepping gait, hunchback posture, reduced responsiveness, dropping of eyelids, wet coat in the muzzle/neck area. One female rat died during exposure, which was considered to be technically-exposure related (death due to asphyxiation as a result of an irreversible head rotation in the exposure tube) rather than regarded to be a substance induced effect.

Reflex measurements

The observed statistically significant changes were not considered to be exposure related and therefore lexicologically relevant due to a lack of a clear concentration dependency.

Body weights

No significant depressions were noted from any of these groups on any subsequent observation period.

Animals sacrificed at the end of the observation period: Specific exposure related findings were not observed. Except for some minor lesions in the lung of one male animal of the 35 gm/m³ air (lung with isolated dark-red to brownish foci), all survivors showed no macroscopic alterations.

Animal that died during the exposure period: The animal that died during exposure probably due to asphyxiation showed minor macroscopic alterations (red-bluish discoloration of lung, marbled kidneys), which were considered to be of no lexicological importance.

Applicant's summary and conclusion