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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study OECD 403 - Annex (1981) with methodological deficiencies (concentration in the air not quantifiable; only 6 animals used for the 30 min exposure time [OECD: 10]; only 7 days observation period [OECD:14]). No monitoring of the concentration in the exposure chamber.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD Guideline 403 (Acute Inhalation Toxicity) Inhalation Hazard Test
Principles of method if other than guideline:
BASF-TEST: It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (usually 20°C). Young adult laboratory rats were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of usually 3 rats per sex were sequentially exposed to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted disc in a glass cylinder for different time periods. The exposure time not causing lethality was usually tested twice.
No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of the amount of the test substance weight loss during exposure. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals.
GLP compliance:
no
Test type:
other: inhalation hazard test
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
Details on test material:
- Name of test material (as cited in study report): Methoxyisopropylamin
- Physical state: liquid (pH 12.2 in water)
- Purity: 99,5%

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Mean body weight at study initiation:
IHT 20°C / 3 min experiment 1: group weight 483 g (12 animals)
IHT 20°C / 10 min experiment 2: group weight 480 g (6 animals)
IHT 20°C / 30 min experiment: group weight 474 g (6 animals)

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged; no vehicle
Analytical verification of test atmosphere concentrations:
no
Remarks on duration:
3; 10; 30 min at 20 °C
Concentrations:
70,9 mg/l (=17654 ppm) was calculated as the nominal concentrations in the 10 and 30 min experiments. 168 mg/l (= 46200 ppm) was noted as the nominal concentration in the 3 min experiment. All inhalation exposures were conducted at 20 °C.
No. of animals per sex per dose:
6 (3 and 10 min experiment); 3 (30 min experiment).
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- The animals were examined for mortality and clinical signs of toxicity
- Frequency of observations: several times at the application day and thereafter once each working day
- Body weights were recorded at the beginning of the study
- Necropsy of survivors and animals which died performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: LD50 (IHT)
Effect level:
< 71 mg/L air (nominal)
Exp. duration:
30 min
Mortality:
3 min experiment: no mortalities
10 min experiment: 2 animals died during the night following inhalation.
30 min experiment: 5 animals died within the first 2 days.
Body weight:
- Mean body weight at study initiation:
IHT 20°C / 3 min experiment 1: group weight 483 g (12 animals)
IHT 20°C / 10 min experiment 2: group weight 480 g (6 animals)
IHT 20°C / 30 min experiment: group weight 474 g (6 animals)
Gross pathology:
30 min experiment: animals that died: expanded lung (3), bloody smudgy nose (5); sacrificed animals: no abnormalities observed after 7 days.
10 min experiment: dystelectase of the lung (1), bloody smudgy nose (2); sacrificed animals: no abnormalities observed after 7 days.
Other findings:
10 and 30 min experiments: attempts to escape, severe irritation of the mucosa, irregular respiration and respiratory sounds.

Any other information on results incl. tables

Under the conditions choosen for this study, the nominal concentration of the test substance in the air that caused the death of more than 50% of the animals after 30 min was calculated to be below 71 mg/L air. However, no analytical monitoring of the test substance was performed.

Applicant's summary and conclusion