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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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
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

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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 820 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
2 810 mg/kg bw
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

Applicant's summary and conclusion