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Diss Factsheets

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:
02. Jun 1978 - 25. Aug 1978
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:
1979
Report date:
1979

Materials and methods

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.

The LD50 value was estimated on the basis of the observed mortalities.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethoxyethylamine
EC Number:
203-801-5
EC Name:
2-ethoxyethylamine
Cas Number:
110-76-9
Molecular formula:
C4H11NO
IUPAC Name:
2-ethoxyethylamine
Details on test material:
- Name of test material (as cited in study report): 2-Aethoxyaethylamin
- Analytical purity: 98 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Weight at study initiation: male. 226 g (mean), female: 176 g (mean)
- Fasting period before study: 16-20 h
- Diet: Herlian MRH (Eggersmann KG, Rinteln) ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6.81, 10, 12.1, 14.7, 21.5%
Doses:
681, 1000, 1210, 1470, 2150 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: daily
- Frequency of weighing: days 0, 3, 7, 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
950 mg/kg bw
Mortality:
see detail in remarks on results.
Clinical signs:
other: 2150 mg/kg bw: 15 min post application: irregular respiration, apathy, staggering, spastic gait. 4 h post application: pain reflex, ruffled fur, feces discoloured, exsiccosis, narcosis. 1470 mg/kg bw: 15 min post application: spastic gait, staggering.
Gross pathology:
2150 mg/kg bw:
Heart: diletation on the right ventricle, congestion.
Stomach: strong diffuse erythema of the mucosa.
Intestine: atonic, erythema of the mucosa, diarrhetic content.

1470 mg/kg bw:
Heart: diletation on the right ventricle, congestion.
Stomach: strong diffuse erythema of the forestomach mucosa.
Intestine: atonic, erythema of the mucosa, dark content.
Lung: partly acute swelling.
Peritoneum: ascites

1210 mg/kg bw:
Peritoneum: diffuse erythema, hemorrhagic gastritis
Intestine: atonic, erythema, dark diarrhetic content.

1000 mg/kg bw:
Heart: diletation on the right ventricle, congestion.
Stomach: erythema of the glandular stomach.
Intestine: atonic, erythema of the mucosa, dark diarrhetic content.

Sacrificed animals: without abnormalities.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg bw) Gender   dead within 1h  dead within 1 day  dead within 2 days  dead within 7 days  dead within 14 days  
 2150 male  0/5  5/5 5/5 5/5  5/5  
  female 0/5  5/5   5/5  5/5  5/5   
 1470  male 0/5  5/5  5/5  5/5   5/5  
female   0/5  5/5   5/5  5/5   5/5  
1210 male   0/5  4/5  4/5   4/5   4/5  
female  0/5  5/5   5/5   5/5   5/5  
 1000  male  0/5 0/5   0/5 0/5  0/5   
  female   0/5   3/5   3/5   3/5   3/5   
681  male   0/5   1/5 1/5   1/5   1/5   
   female  0/5 1/5    1/5   1/5    1/5   

The test substance caused moderate toxicity (including mortality) after a single ingestion and caused local irritations to exposed tissues.

Applicant's summary and conclusion