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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable report which meets basic scientific principles. Hydroxyethylpiperazine is the major constituent (ca. 40%) of the test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(weight variations in animals exceed 20% of the mean weight, observation period of 7 days, no details on animal husbandry)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydroxyaethylpiperazin
- Analytical purity: 99 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult laboratory rats
- Weight at study initiation: 100 - 224 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
(doubly distilled)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10-20 mL/kg bw
The doses were administered as aqueous solutions of 8% (800 cm³/kg), 20% (1600 cm³/kg) and 30% (3200, 4000 and 5000 cm³/kg) test substance.
Doses:
800, 1600, 3200, 4000 and 5000 cm³/kg (849, 1698, 3396, 4244, 5305 mg/kg bw - conversion in mg/kg is based on the density: d= 1.06 g/cm³)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Frequency of weighing: before the start of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 244 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Corresponds to 4000 cm³/kg; the mg/kg was calculated on the density d: d= 1.061 g/cm³. 1 male/3 females died within the first 24 h post exposure in this dose group.
Mortality:
5305 mg/kg bw: All females died within the first 24 h and 3 males died within 48 h.
4244 mg/kg bw: 1 male and 3 females died within the first 24 h.
3396 mg/kg bw: 1 male and 2 females died within the first 24 h.
1698 mg/kg bw: 1 animal died within 7 days.
Clinical signs:
5305 and 4244 mg/kg bw: high stepping gait, motor excitation, intermittent respiration, abdominal position and paresis (hindlimb), immediately after application; piloerrection, nose and eyes with reddish crusts, intermittent respiration, apathy and squatting posture until including day 3. No clinical signs and findings in the surviving animals from the fifth post observation day onward.

3396 and 1698 mg/kg bw: irregular respiration and squatting posture from hour 2 until hour 4 after application. Irregular respiration and piloerection until day 4. No clinical signs and findings in the surviving animals from the fifth post observation day onward.
Body weight:
no data
Gross pathology:
Animals that died:
5305 mg/kg bw: smeared fur (snout and anogenital region), dilatation of the stomach and intestine (partly filled with blood and liquid content).
4244 mg/kg bw: smeared fur (snout); dilatation of the stomach and intestine (partly filled with blood and liquid content).
3396 mg/kg bw: smeared fur (snout and anogenital region), diarrhea.
Animals examined at termination of the study: Organs without particular findings.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg)  Conc.(%)  dead within 1h  dead within 1 day  dead within 2 days  dead within 7 days  
 5305  30  0/10  6/10  8/10  8/10  
 4244  30  1/10  4/10  4/10  4/10  
 3396  30  0/10  3/10  3/10  3/10  
 1698  20  0/10  0/10  0/10  1/10  
 849  8  0/10  0/10  0/10  0/10  

Applicant's summary and conclusion