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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an acceptable BASF-test; GLP was not compulsory at the time the study was conducted.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF test:
The substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-butyliminodiethanol
EC Number:
203-055-0
EC Name:
2,2'-butyliminodiethanol
Cas Number:
102-79-4
Molecular formula:
C8H19NO2
IUPAC Name:
2,2'-(butylimino)diethanol
Details on test material:
- Name of test material (as cited in study report): Butyldiäthanolamin
- Physical state: liquid
- Analytical purity: 100%

Test animals

Species:
mouse
Strain:
other: the mice were designed as Kisselegg mice
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: young adult, no more data provided
- Weight at study initiation: males, 19 - 34 g; females, 18 - 26 g
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: water with Traganth
Details on exposure:
The mice received single i.p. injections of the test item at a concentration of 2, 4, 8 and 20% in the vehicle.
Doses:
Original values as given in study report: 200, 250, 320, 400, 800 and 2000 mm3/kg bw
Values converted into mg/kg bw (density: 0.970 g/cm3): ca. 190, 240, 310, 390, 780 and 1900 mg/kg bw
No. of animals per sex per dose:
Five/sex/group
Control animals:
no
Details on study design:
The animals were observed over a period of 14 days for mortality and clinical symptoms of toxicity, and were subjected to necropsy and gross pathological examination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 250 mg/kg bw
Based on:
test mat.
Remarks on result:
other: original value was given as 260 mm3/kg bw after 14 days
Mortality:
Cumulative mortalities over 14 days:
- At 190 mg/kg bw mortality was 30%.
- At 240 mg/kg bw mortality was 30%.
- At 310 mg/kg bw mortality was 100%.
- At 390 mg/kg bw, mortality was 100% after 7 days.
- At 780 mg/kg bw, mortality was 100% after 7 days.
- At 1900 mg/kg bw, mortality was 100% after 7 days.
Clinical signs:
The mice displayed a series of clinical signs of toxicity, which included among other accelerated breathing, dyspnea, tremor, convulsion and staggering. The symptoms appeared immediately after injection and were severe at the 2 highest dose levels, leading to death within 24 hours following treatment.
In the remaining treated groups, similar symptoms were reported as above, which however were less severe compared to the high doses. Those animals that survived (i.e., 190 and 240 mg/kg bw dose levels) recovered after 12 days.
Gross pathology:
Adhesions in the abdomen, signs of skin irritation at the injection site, hemorrhagic enteritis, ascites.

Applicant's summary and conclusion