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Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, study report, which meets basic scientific principles, however the limit dose is much to low, therefore the study is considered not relevant for chemical safety assessment.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980
Reference Type:
other: German translation of study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Phosphoric acid, C16-18-alkyl esters, potassium salts
EC Number:
291-907-2
EC Name:
Phosphoric acid, C16-18-alkyl esters, potassium salts
Cas Number:
90506-45-9
Molecular formula:
not applicable for UVCB substances
IUPAC Name:
Reaction product of Phosphorus Pentoxide and C16 – 18 (even numbered) Alcohol, neutralized with Potassium Hydroxide
Details on test material:
Silastol 11137 was used as a 1 %, watery emulsion, light milky

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Paderbom
- Age at study initiation:
- Weight at study initiation: 172 - 216 g
- Fasting period before study:
- Housing: individualy
- Diet (e.g. ad libitum): ad libitum, Ssniff/ Intermast
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
The rats were immobilized in special tubes and connected to the inhalation chamber for four hours, so that only their noses came in contact with the aerosol. The chamber used in this essay (Kimmerle system) consists of a 20 L plastic cylinder with one total air change every two minutes.
Air is supplied fran a canpressor air line into nebulizing nozzle.
Prior to starting the test an exact air flow of 10 L per minute is adjusted using a flow meter. The nebulizing nozzle produces on aerosol with
particle sizes of about 2 - 5 µm.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
200 µl/L chamber concentration (1% aqueous solution)
No. of animals per sex per dose:
10 aninmals/ sex/ dose
Control animals:
no
Details on study design:
At the conclusion of the four hour exposure period the animals are removed from the chamber, their heads carefully cleaned of any
material and housed in indiVidual cages. Observations are made continuously of the appearance and behaviour of the animals during
the exposure period and at frequent intervals thereafter for a total of 14 days. At the end of the observation period the rats are weighed,
sacrificed and gross autopsies are performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 200 other: µL/L
Based on:
test mat.
Exp. duration:
4 h
Mortality:
1/20 within 24 hours.
Clinical signs:
other: During the exposure time and several hours thereafter the animals showed a light handicap of the coordination ability as well as a slight diarrhea. After 24 hours the animals appeared clinically normal.
Body weight:
During boths weeks of the observation period all animals showed normal weight gain
Gross pathology:
All animals sacrificed at termination showed no macroscopic visible pathological-anatomical changes in the body cavities.

Applicant's summary and conclusion

Interpretation of results:
other: The tested limit dose is very low, therefore the study is considered not relevant for chemical safety assessment.
Executive summary:

The acute inhalation toxicity of "Silastol 1431 - 1 % in water" in rats was evaluated. Under the experimental procedures, one animal was found dead during the observation period of 14 days. The LC50 in rats was found to be greater than 200 µL/L air.

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