1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-03-14 to 1979-04-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Non GLP study performed according to a method equivalent to OECD Guideline 401. Limited information was reported on test conditions, however sufficient animals were tested.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol

EC Number:

264-261-4

EC Name:

1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol

Cas Number:

63469-23-8

Molecular formula:

C11H26N2O2

IUPAC Name:

1-{[3-(dimethylamino)propyl](2-hydroxypropyl)amino}propan-2-ol

Test material form:

liquid

Details on test material:

Details described in study specific records

Specific details on test material used for the study:

- Name of test material (as cited in study report): 4236-21-35
- Substance type: Clear colourless liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Mass.
- Age at study initiation:
- Weight at study initiation: 220 to 314 grams
- Fasting period before study: approximately seventeen hours prior to administration of test material
- Housing: Following dosing, the rats were individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test material was administered by oral intubation in the form received. The dose levels were calculated according to the density provided by the sponsor as being 0.944 g/mL.

Doses:

The animals were dosed at the following dose levels: 1000, 1400, 2000, 2800 and 4000 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: Bodyweights were recorded prior to fasting, at day 7 and at the termination of the study (day 14)
- Necropsy of survivors performed: yes: A gross necropsy was performed on all animals at the time of death or terminal sacrifice (day 14).
- Observations for mortality and overt signs of effect were made at 0-2 hours and at 4-6 hours following dosing and daily thereafter for fourteen days.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 200 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 900 - <= 2 500

Mortality:

1000 mg/kg: 1/10 animals died
1400 mg/kg: 0/10 animals died
2000 mg/kg: 2/10 animals died
2800 mg/kg: 9/10 animals died
4000 mg/kg: 10/10 animals died

Clinical signs:

other: other: other:

Body weight:

other body weight observations

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for this substance is 2200 mg/kg with 95% confidence limits of 1900 to 2500 mg/kg. Based on this result, the test substance is not to be classified according to the CLP Regulation.