Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
comparable to guideline study with acceptable restrictions
Remarks:
without GLP status

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethylpiperazine
EC Number:
226-166-6
EC Name:
1-ethylpiperazine
Cas Number:
5308-25-8
Molecular formula:
C6H14N2
IUPAC Name:
1-ethylpiperazine
Details on test material:
- Name of test material (as cited in study report): Ethylpiperazin, Partie 6, Abl.Nr. 64-6112
- Analytical purity: 98%
- PSN 88/0569

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Thomae, Biberach/Germany
- Weight at study initiation: 181 g (mean weight males), 180 g (mean weight females)
- Fasting period before study: 16 hours before administration, except water
- Housing: groups of 5
- Diet: Kliba Labordiaet, 343; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 week

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20, 10, 4.64 mg/ 100 mL
- Amount of vehicle (if gavage): 10 mL/kg
Doses:
464, 1000, 2000 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: Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Frequency of weighing: at day 0, 7 and 13 of the study
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 000 - 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 4 male and 4 female animals of the 2000 mg/kg bw dose group died. Observed clinical signs were reversible within 14 days.
Mortality:
4 male and 4 female animals of the 2000 mg/kg bw dose group died during the first two days post treatment. No further mortality observed.
Clinical signs:
2000 mg/kg bw dose group:
Dyspnea, apathy, staggering, piloerection and poor general state was observed post treatment (4 hours) and up to 2 days after treatment in all animals. Twitching was observed 4 hours after treatment in the female animals. Afterwards, no clinical signs were observed.
No clinical signs were observed in the 464 and 1000 mg/kg bw dose groups.
Body weight:
Mean male body weights 7/13 days post treatment (2000, 1000, 464 mg/kg bw dose groups): 224, 245, 265 / 262, 280, 301 g
Mean female body weights 7/13 days post treatment (2000, 1000, 464 mg/kg bw dose groups): 203, 209, 234 / 213, 218, 249 g
Gross pathology:
Animals that died (male + female): General congestion.
Stomach: atonic; reddened mucosa; striking liquid contents.
Intestines: atonic; reddened mucosa; liquid contents, in most animal bloody.
No pathological findings noted in surviving animals.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria