Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
10 animals per dose, 7 days post-exposure observation
Principles of method if other than guideline:
BASF-test, see details in remarks on material and methods.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-aminoethoxy)ethanol
EC Number:
213-195-4
EC Name:
2-(2-aminoethoxy)ethanol
Cas Number:
929-06-6
Molecular formula:
C4H11NO2
IUPAC Name:
2-(2-aminoethoxy)ethan-1-ol
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aminodiglykol, 2-(2 Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 186 - 280 g (mean); female: 166 - 218 g (mean)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 %, 20 % and 30 %.

Doses:
200, 1600, 2000, 2500, 3200, 4000, 5000, 6400 µl/kg bw = 212, 1696, 2120, 2650, 3392, 4240, 5300, 6784 mg/kg bw (conversation is based on the density of 1.06 g/cm3).
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: several times on the day of application and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 400 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 3 700 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 3 000 mg/kg bw
Mortality:
See details in remarks on results.
Clinical signs:
other: Staggering, abdomial position, apathy, irregular respiration, shallow flanks, closed eyes, ruffled fur.
Gross pathology:
2120 - 6784 mg/kg bw: gastrorrhagia, sagged gastrointestinal tract, serous smeared snouts.

Any other information on results incl. tables

Mortality

 Dose (mg/kg bw)  Conc. (%) Gender  1 h  24 h  48 h  8 days                
6784  30 male 0/10 10/10 10/10 10/10                  
6784   30 female 0/10 10/10 10/10 10/10                  
5300  30 male 0/10 0/10 8/10 8/10                
4240  30 male 0/10 0/10 8/10 8/10                
3392  30 male 0/10 3/10 3/10 3/10                  
3392   30 female  0/10 8/10 8/10 8/10                
2650   20 female 0/10 0/10 3/10 3/10                  
2120  20 female 0/10 0/10 1/10 1/10                  
 1696  20 male 0/10 0/10 0/10 0/10                  
 1696  20 female 0/10 0/10 0/10 0/10                  
 212  2 male 0/10 0/10 0/10 0/10                  
 212  2 female 0/10 0/10 0/10 0/10                  

The test substance caused systemic toxicity (including mortality) in a dose dependent manner.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
oral LD50 ca. 3400 mg/kg (male/female)
Executive summary:

In a study comparable to OECD guideline 401, the LD50 for oral acute toxicity in rats was calculated as ca. 3400 mg/kg body weight. Doses of 212, 1696, 2120, 2650, 3392, 4240, 5300, and 6784 mg/kg bw of an aqueous solution were applied by gavage followed by a post dose observation period of 7 days. Main clinical signs observed were staggering, apathy, irregular respiration, shallow flanks, abdomial position, closed eyes, ruffled fur. At necropsy, gastrorrhagia, sagged gastrointestinal tract and serous smeared snouts were observed.