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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was performed according to following guidelines: OECD 401,EPA FR, Vol. 50, No.188 (September 27, 1985) and in compliance with to the GLP Regulations. No significant deviations can be observed from the study guidelines, which could have an impact on the performed study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
purity and storage condition not reported
Qualifier:
according to guideline
Guideline:
other: EPA FR Vol.50,No.188,1985
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-dimethylaminoethanol
EC Number:
203-542-8
EC Name:
2-dimethylaminoethanol
Cas Number:
108-01-0
Molecular formula:
C4H11NO
IUPAC Name:
2-(dimethylamino)ethanol
Details on test material:
- Name of test material (as cited in study report): 6398-36-1
- Physical state: clear, colorless liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: 91-018
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- Storage condition of test material: no data
- Other:specific gravity=0.886 gm/mL

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 Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: young adults
- Weight at study initiation: 229-325 g
- Fasting period before study: yes
- Housing:individually in stainless steel 1/2" wire mesh cages, sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council
- Diet (e.g. ad libitum): Wayne Teklad Lab Blox, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: min. 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
800, 1250 and 2000 mg/kg
No. of animals per sex per dose:
5 per sex per dose
Control animals:
other: not required according to the OECD 401
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at 1,4 and 24 hours after dosing and once daily through Day 14. Viability: once a day. Body weights: d0, d7 and d14 or when found dead.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 calculations performed via Litchfield and Wilcoxon on Pharmacological Calculations System, version 4.1.

Results and discussion

Preliminary study:
dose-range-finding study: 3 groups x 2 rats (1 ♂ and 1♀, fasted): dose levels 500, 2500 and 5000 mg/kg, orally by gavage.
The rats were observed at approximately 1, 4, 24, 48 and 72 hours after dosing for pharmacological and toxicological effects.
0/2 animals died at the 500mg/kg dose level. 2/2 animals died at both the 2500 and 5000 mg/kg dose levels.
Based upon these results , dose levels for a definitive LD50 were determined.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 182.7 mg/kg bw
95% CL:
907 - 1 542.2
Sex:
male
Dose descriptor:
LD50
Effect level:
1 203.2 mg/kg bw
95% CL:
816 - 1 774.2
Sex:
female
Dose descriptor:
LD50
Effect level:
1 220.1 mg/kg bw
95% CL:
725.6 - 2 051.6
Mortality:
-2/10 animals died at the 800 mg/kg dose level.
-5/10 animals died at the 1250 mg/kg dose level.
-9/10 animals died at the 2000 mg/kg dose level.
Clinical signs:
other: -decreased activity and muscle tone, ptosis, abnormal gait, abnormal stance, chromodacryorrhea, diarrhea, tremors, prostration and dyspnea
Gross pathology:
Necropsy of the animals dying on study revealed fluid-filled and distended stomachs and intestines.
No visible lesions were observed in animals at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on the results from the Acute Exposure Oral Toxicity in rats, the Definitive Acute Oral LD50 in males and females for 6398-36-1, was determined to be 1182.7 mg/kg (95% CL of 907.0 to 1542.2 mg/kg). The LD50 in males was determined to be 1203.2 mg/kg (95%CL of 816.0 to 1774.2 mg/kg). The LD50 in females was determined to be 1220.1 mg/kg (95%CL of 725.6 to 2051.6 mg/kg).
Executive summary:

Dimethylethanolamine was administered by gavage to Sprague Dawley rats at doses 800, 1200 and 2500 mg/kg bw. The animals were observed daily for toxicological effects through the day 14. The test material caused dose-dependent mortalities in the exposed animals. Decreased activity and muscle tone, ptosis, abnormal gait, abnormal stance, chromodacryorrhea, diarrhea, tremors, prostration and dyspnea were observed in treated animals. Necropsy of the animals dying on study revealed fluid-filled and distended stomachs and intestines. No visible lesions were observed in animals at terminal necropsy.

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