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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:
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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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/ pain reflex failed, tremor, twitches
1000 and 2150 mg/kg dosing groups: strong coloured (concentrated) urine
Body weight:
nothing abnormal reported
Gross pathology:
haemorrhagic gastritis, irritated gut mucosa, bloody stomach content, acute venous hyperaemia

Applicant's summary and conclusion