2,2'-oxydi(ethylamine)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-08-22 - 1983-09-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-oxydi(ethylamine)

EC Number:

220-395-5

EC Name:

2,2'-oxydi(ethylamine)

Cas Number:

2752-17-2

Molecular formula:

C4H12N2O

IUPAC Name:

2-(2-aminoethoxy)ethan-1-amine

Specific details on test material used for the study:

- Name of test material (as cited in study report): 5601-22-1, Order #J-169
- Substance type: clear liquid
- Physical state: liquid
- Purity: responsibility of the sponsor
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration.
- Other: Specific gravity - 0.955 gm/mL

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Blue Spruce Farms, Altamont, New York or Hilltop Lab Animals, Inc. Scottdale, Pennsylvania
- Weight at study initiation: 180 - 360 grams after fasting. The weight variation in animals or between groups did not exceed ± 20%
- Fasting period before study: yes
- Housing: Separate isolation by test system.
- Diet (e.g. ad libitum): Wayne Lab Blox, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): Availability - fresh tap water, fit for human consumption, ad libitum, using an automatic watering system supplied by Edstrom Industries, Inc. Waterford, Wisconsin.
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

400, 630, 1000, 1250 and 1600 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at approximately 1, 2, 4 and 24 hours after dosing and twice daily for 14 days for pharmacotoxic, CNS effects and mortality. On days 7 and 14, body weights were recorded.
- Necropsy of survivors performed: yes. The surviving rats were sacrificed by CO2 inhalation and a gross necrospy performed.

Statistics:

According to the method of Litchfield and Wilcoxon (1949).

Results and discussion

Preliminary study:

Dose-range finder with 4 rats (2 males, 2 females) per concentration indicated:
1000 mg/kg: 3/4 died; 2000, 4000 and 8000 mg/kg: all rats died.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

961 mg/kg bw

Based on:

test mat.

95% CL:

>= 746 - <= 1 239

Mortality:

400 mg/kg: 1 male died after 1 day
630 mg/kg: no mortality
1000 mg/kg: 1 male and 2 females died after 1 day, 1 female died after 2 days
1250 mg/kg: 2 males died after 1 day, 1 male after 2 days and 1 male after 11 days; 5 females died after 1 day
1600 mg/kg: 3 males died after 1 day and 1 male died after 5 days; 5 females died after 1 day

Clinical signs:

other: Signs observed included decreased body tone and activity, poor grooming, piloerection, salivation, lacrimation, abnormal gait and stance, cyanosis, hypersensitivity, body drop, semi-prostration, diarrhea, dyspnea and prostration.

Gross pathology:

Necropsy of the animals dying on study revealed stomach and intestines fluid-filled and hemorrhagic. The lungs were congested and edematous. Discolored testes and spleen, pancreas, ulcers of the stomach, hydrothorax and hemorrhages of testicular connective tissue were also observed. Terminal necropsy revealed no visible lesions in any of the remaining animals.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Based upon the results of the acute oral toxicity study in rats, the calculated acute oral LD50 for male and female rats treated with the test substance was determined to be 961 mg/kg with confidence limits of 746 to 1239 mg/kg. Based on the results of this study and according to the CLP criteria, this substance should be classified as acute oral toxic category 4.