Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Dyspnea, apathy, staggering, piloerection, salivation, poor general state were observed in animals from dose groups 2150 mg/kg bw, and higher
Body weight:
Normal body weight gain
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.

Applicant's summary and conclusion