Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-09-03 to 1987-10-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP but internally audited. Scientifically acceptable study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
3 rats / sex instead of 5 rats / sex
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: 8 to 9 weeks
- Mean weight at study initiation: males: 270g, females: 196 g (no animal exceeding +/- 20% of the mean weight)
- Fasting period before study: 16 h
- Housing: Stainless steel wire mesh cage (Type DK III)
- Diet: ad libitum (except during exposition)
- Water: ad libitum (except during exposition)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes: not specified ("fully air conditioned")
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To: 1987-09-03 to 1987-09-17

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass frit (grain size 90-150 µm.) filled with product, dissipated into glass tubes containing animals; exhaust vent
- Exposure chamber volume: not specified
- Method of holding animals in test chamber: not restrained
- Source and rate of air: 200 L / h

- System of generating aerosols: air flowing through product in glass frit
- Treatment of exhaust air: vented
- Temperature, humidity, pressure in air chamber: ambient (laboratory conditions: 19 to 25°C)

Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
mean: 13,6 mg/L (calculated by a net total of 19.1 g test item spent in 1400 L air)
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: clinical signs on workdays, fatalities daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 13.6 mg/L air
Based on:
test mat.
Remarks on result:
other: nominal concentr.
Mortality:
no
Clinical signs:
During exposure: eyelid closure, respiratory rate increased, panting, respiratory sounds, reddish discharge from nose
After exposure: respiratory sounds, reddish discharge from nose (tested positive for blood), stilted gait
Body weight:
not documented
Gross pathology:
no abnormalities detected
Other findings:
no

Applicant's summary and conclusion