Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study protocol: 2-Diisopropylaminoethylamin

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
The animals were held (5 rats per cage; type stainless steel wire mesh cages) in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h dark and 12 h light.
The animals were identified using cage cards.
The rats were offered a standardized animal laboratory diet was well as drinking water ad libitum.
Young adult rats of a comparable weight were used.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Form of administration: solution
Reason for the vehicle: aqueous formulation corresponds to the physiological medium
Concentration (g/100 ml): 2,150, 6,810, 20,000
Administration volume (ml/kg): 10
Doses:
215, 681, 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Recording of signs and symptoms several tims on the day of administration, at least once each working day. Check for moribund and dead animals twiche each working day and once on public holidays.
Withdrawal of food about 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that die as soon as possible.
Observation period: 14 days
The animals were given no feed about 16 h before administration (water was available ad libitum).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 681 - < 2 000 mg/kg bw
Mortality:
Male animals: 215 mg/kg: no deaths; 681 mg/kg: 1/5 after 14 days; 2000 mg/kg: 5/5 after 14 days
Female animals: 215 mg/kg: no deaths; 681 mg/kg: 1/5 after 14 days; 2000 mg/kg: 5/5 after 14 days
Clinical signs:
Impaired general state (females only), poor general state, dyspnea, apathy, staggering, tremor (females only), twitching (females only), spastic gait (females only), cyanosis, red-coloured urine, piloerection (males only), exsiccosis (males only), extended abdomen (males only).
Body weight:
Mean body weights for male animals: 186 g at study start, 283 g after 13 days
Mean body weights for female animals: 178 g at study start, 221 g after 13 days
Gross pathology:
Animals that died: general congestion
Sacrificed animals: nothing abnormal detected

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria