Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (comparable to guideline study)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
only male animals tested; lack of details on test substance
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Triglycerides, mixed decanoyl and octanoyl
- Date of arrival: 1976-05-18
- Physical state: clear, oily, odourless liquid
- Analytical purity: no data
- Storage condition of test material: dark, at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: approx. 170 g
- Housing: 2 per Makrolon Type 3 cage with Vermiculite pad
- Diet (e.g. ad libitum): standard pelled diet
- Water (e.g. ad libitum): tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 60 +/-5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindric inhalation chamber "INBIFO-MAKROLON-Tierrohre Typ 1" with stainless steel head cones, according to KIMMERLE apparatus with 20 animal tubes
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: cylindric tube
- Source and rate of air: 7.11 L air flow/min
- Method of conditioning air: 0.2 mL of test substance per min was pumped using a dosing pump of BRAUN, Melsungen
- System of generating particulates/aerosols: aerosol nozzle, nozzle orifice 0.15 mm, BUNDSCHUH; Griesheim
- Measured test substance concentration in inhalation chamber: 28.1 µL/ L air
- Method of particle size determination: no further details reported
- Treatment of exhaust air: no further details reported
- Temperature, humidity, pressure in air chamber: no further details reported
"Zyklon" (BCRIA sampler) was used to sample precipitated particles with a particle size > 5 µm
A cambridge filter was used to sample respirable particles.
Gravimetric analyses were performed to determine the respirable test substance concentration.

TEST ATMOSPHERE
- Brief description of analytical method used: during exposure every hour the aerosol concentration was measured in the inhalation chamber directly in the area of animals noses (head cones)
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
1.97 µL test substance / L air was < 5 µm diameter
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gravimetric analyses were performed to determine the respirable test substance concentration.
Duration of exposure:
6 h
Concentrations:
- calculated test substance concentration: 28.1 µL test substance (unchanged oil) / L air
(0.2 mL of the liquid test substance per min was pumped through the aerosol nozzle)
- measured respirable test substance concentration: 1.97 µL/ L air (< 10 µm diameter particle size)
No. of animals per sex per dose:
10
Control animals:
other: yes, sham-exposed
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: during exposure, after exposure and thereafter daily
- Frequency of weighing: at beginning, directly after exposure and at the end of 14 d observation period
- Necropsy of survivors performed: yes, 3 test animals and 1 control animal were euthanized 1 h after exposure, all other animals were necropsied 14 days after exposure
- Other examinations performed: Trachea and lungs of all animals were histopathologically analyzed.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 1.86 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: equivalent to 1.97 µL / L air (analytical, max. attainable concentration)
Mortality:
No deaths occured
Clinical signs:
other: During exposure the animals showed not signs of toxicity. No signs of systemic toxicity were observed in any of the animals during the 14 d observation period.
Body weight:
All animals showed the expected gain in body weight
Gross pathology:
No abnormal findings
Other findings:
Histopathology: No abnormal findings in lungs or tracheae.
Microscopically no deposits of oily test substance could be detected in the respiratory tissues.

Any other information on results incl. tables

According to the descriptions in this study report it can be assumed that the maximum attainable concentration of the test substance was used for aerosol inhalation exposure.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU