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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jun 1965 - 20 Jul 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
BASF-Test
Principles of method if other than guideline:
BASF-Test. See further details in remarks on materials and methods.
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monomethylaethanolamin
- Analytical purity: 99-100 %

Test animals

Species:
rat
Strain:
other: US-rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 148 - 230 g; females: 112 - 150 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5, 2, 8, 16, 20 %


Doses:
25, 200, 800, 1600, 2000, 2500 and 3200 µl/kg bw (23.5, 188, 752, 1504, 1880, 2350 and 3008 mg/kg bw - conversation into mg/kg bw is based on the density: d=0.94 g/cm3)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 880 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: conversion in mg/kg is based on the density: d=0.94 g/cm3
Mortality:
See details in remarks on results.
Clinical signs:
3008 mg/kg bw: abdominal position, irregular, accelerated respiration, staggering, calm behavior, chewing compulsions.
2350 mg/kg bw: calm behavior, staggering, chewing compulsions, gasping, dyspnoea. After 24 h squatting posture, ruffled fur, irregular respiration
1880 mg/kg bw: high stepping gait, staggering, smeared fur, diarrhea.
1504 mg/kg bw: dyspnoea, chewing compulsion, partially calm behavior. After 24 h crusted eyes and ruffled fur.
23.5, 188 and 752 mg/kg bw: after application calm behavior.
Body weight:
no data
Gross pathology:
3008 mg/kg bw: 1 x intestinal atony.
1880 mg/kg bw: 1 animal with distended ulceration with phlegmone and abscess of the entire glandular stomach. 1 x intestinal irritation.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg bw)  Gender  conc. %  1 h  24 h  48h  day 7  day 14
 3008  male 20 0/5   5/5 5/5  5/5 5/5
 3008  female 20  0/5 4/5 5/5 5/5 5/5 
 2350  male 20 0/5 2/5 3/5 3/5  3/5 
 2350  female 20 0/5 4/5 5/5 5/5 5/5 
1880  male 20 0/5  1/5  1/5 1/5 2/5 
1880  female 20 0/5 1/5 1/5 4/5 4/5 
1504  male 16 0/5  1/5  1/5 1/5 1/5 
 1504 female  16  0/5 1/5  1/5 1/5 1/5 
 752  male 8 0/5  0/5  0/5  0/5 0/5 
 752  female 8 0/5  0/5  0/5 0/5 0/5 
 188  male  2 0/5 0/5 0/5  0/5

0/5 

 188  female  2 0/5 0/5 0/5 1/5 1/5 
 23.5  male  0.5  0/5 0/5 0/5  0/5  0/5  
 23.5  female  0.5  0/5   0/5 0/5 0/5 0/5  

The application of the test substance caused systemic toxicity, including mortality, in a dose dependent manner.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The application of the test substance caused systemic toxicity, including mortality, in a dose dependent manner.
Executive summary:

In an acute oral study a test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of MMEA (BASF AG, 1965, XV/126). The animals were observed for mortality and for clinical symptoms of toxicity. 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. The LD50 value was estimated on the basis of the observed mortalities.
At low doses (23.5 188 and 752 mg/kg bw), calm behavior was observed by treated animals. Dyspnoea, chewing compulsion, partially calm behavior occurred after application of 1504 mg/kg bw.
 After 24 h, crusted eyes and ruffled fur. At high doses (1880, 2350 and 3008 mg/kg bw), dyspnoea, high stepping gait, staggering, smeared fur, diarrhea, calm behavior, chewing compulsions and gasping were observed. After 24 h squatting posture, ruffled fur, irregular accelerated respiration and abdominal position were still present.
At 1880 mg/kg bw: 1 animal had distended ulceration with phlegmone and abscess of the entire glandular stomach and intestinal irritation. At the highest dose, intestinal atony was observed in one animal.