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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
nda
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: No GLP or purity info. Similar to OECD 403 but with severe deviations. Used as supporting study only due to restrictions. Only 2 concentrations used. LC50 is a less than value due to deaths.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Principles of method if other than guideline:
Used as supporting study only due to restrictions.
- Only 2 concentrations used.
- LC50 is a less than value due to deaths.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif: RAI
Sex:
male/female
Details on test animals and environmental conditions:
The test was performed on 36 Tif. RAI rats (18 males/18 females), bred under SPF conditions in our own breeding unit. The animals used were 7 to 8 weeks old and weighed between 170 and 185 g. The males and females were segregated and kept in Macrolon cages, type 4, (9 animals to a cage) during an observation period of 7 days in a room maintained at a constant temperature of 22 ± 1 °C and a relative humidity of approximately 50 %.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
obtained gravimetrically
Duration of exposure:
4 h
Concentrations:
78 & 403 mg/m^3.
No. of animals per sex per dose:
18 males and 18 females
Control animals:
not specified
Details on study design:
The test material was tested for acute inhalation toxicity by the exposure of albino rats to an aerosol generated from this product. The test material was sprayed into the exposure chamber by means of a pressure nozzle. The liquid was injected by a motor-driven syringe at a rate of 0.6 and 3 mL/hr into a stream of compressed air (2 atm.) flowing through a spray nozzle at a rate of 10 L/min. The aerosol mist thus produced was discharged into the exposure chamber.
The test animals were kept in separate PVC tubes positioned radially around the exposure chamber. These tubes were so designed that only the animals snouts were exposed to the aerosol. The animals were not exposed until the aerosol was evenly dispersed throughout the chamber (15 minutes). The exposure time was four hours. The aerosol was sampled on Membrane Filters, pore size 0.2 µm (Satorius, 34 Göttingen, Germany) in the immediate vicinity of the animals hourly after the beginning of the test. The individual concentrations of the test material were determined gravimetrically.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
< 78 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Clinical signs:
After the 4 hour exposure all animals showed dyspnoea, exophthalmos, lateral position, cyanosis and apathy.
Gross pathology:
Autopsy of dead animals: haemorrhages in the lungs and congested organs were seen.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The LC50 of the test material was determined after an observation period of 7 days in rats of both sexes, exposed to the test material for four hours is smaller than 78 mg/m^3, air.
Executive summary:

The LC50 of the test material was determined after an observation period of 7 days in rats of both sexes, exposed to the test material for four hours is smaller than 78 mg/m^3, air.

According to the classification proposed by Sachsse et al. (1974) the test material has a high acute toxicity to the rat by this route of administration.

After the 4 hour exposure all animals showed dyspnoea, exophthalmos, lateral position, cyanosis and apathy. In the autopsy of dead animals, haemorrhages in the lungs and congested organs were seen.