1,1'-(methylimino)dipropan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter, day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(methylimino)dipropan-2-ol

EC Number:

224-536-1

EC Name:

1,1'-(methylimino)dipropan-2-ol

Cas Number:

4402-30-6

Molecular formula:

C7 H17 N O2

IUPAC Name:

1-[(2-hydroxypropyl)(methyl)amino]propan-2-ol

Details on test material:

- Name of test material (as cited in study report): Methyldiisopropanolamin

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH.
- Weight at study initiation: males: 179 - 237 g. females: 180 - 201 g.
- Fasting period before study: animals were given no feed about 16 hours before administration, but water was available ad libitum.
- Housing: Stainless steel wire mesh cages, type DK-III (Becker & Co). 5 animals per cage.
- Diet: ad libitum; Kliba-lobordiaet 343 (Klingentalmuehle AG, Switzerland).
- Water: ad libitum
- Acclimation period: at least 1 week
- Animal identification: identification of groups using cage cards

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 (animal room fully air-conditioned).
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12h/12h (6:00 - 18:00 hours / 18:00 - 6:00 hours)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.81, 21.50, 38.30 and 50.00 % (w/v)
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium.

Doses:

681, 2150, 3830, 5000 mg/kg bw

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: Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (dyspnea, apathy, staggering, piloerection, salivation, general state), body weight, gross pathological examination.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 150 - 3 830 mg/kg bw

Based on:

test mat.

Mortality:

681 and 2150 mg/kg bw dosing groups: no deaths occurred
3830 mg/kg bw group: 4/5 females and 5/5 males died on Day 1 after exposure
5000 mg/kg bw group: 5/5 females and 5/5 males died on Day 1 after exposure

Clinical signs:

other: Dyspnea, apathy, staggering, piloerection, salivation, poor general state were observed in animals from dose groups 2150 mg/kg bw, and higher

Gross pathology:

Animals that died during the test (males and females):
- general congestion
- severe redness of forestomach, glandular stomach and small intestines
- pink colouration of the urine (at 5000 mg/kg bw)

Sacrificed animals (males + females):
- no abnormalities detected in the organs.