Ethanol, 2-amino-, reaction products with ammonia, by-products from

Acute Toxicity: oral

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:

other: Well documented study report, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol, 2-amino-, reaction products with ammonia, by-products from

EC Number:

272-729-4

EC Name:

Ethanol, 2-amino-, reaction products with ammonia, by-products from

Cas Number:

68910-05-4

Molecular formula:

Unspecified

IUPAC Name:

Ethanol, 2-amino-, reaction products with ammonia, by-products from

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): DEA, by-products
- no further data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae GmbH, Biberach, Germany
- Age at study initiation: 12 weeks
- Mean weight at study initiation: 186 g (males), 175 g (females)
- Fasting period before study: 16 hours
- Housing: groups of 5
- Diet: Ssniff laboratory diet ad libitum
- Water: Tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10, 21.5, 31.6, 50 % respectively
- Amount of vehicle (if gavage): 10 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

1000, 2150, 3160, 5000 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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 820 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

2 810 mg/kg bw

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

2 850 mg/kg bw

Mortality:

1000 mg/kg bw dosing group: 0/10
2150 mg/kg bw dosing group: 0/5 males, 1/5 females (1 day)
3160 mg/kg bw dosing group: 4/5 males (day 1 and 2); 3/5 females (day 1)
5000 mg/kg bw dosing group: 10/10 (day 1)

Clinical signs:

other: 3160 and 5000 mg/kg bw dosing groups: dyspnoea, gasping, apathy, staggering gait, abnormal positioning, atony, paresis, salivation, exsiccosis, cyanosis, scrubby fur, ophistotonus of the head, urine concentrated, worse general condition, blink reflex/ pai

Gross pathology:

haemorrhagic gastritis, irritated gut mucosa, bloody stomach content, acute venous hyperaemia