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Registration Dossier
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EC number: 226-166-6 | CAS number: 5308-25-8
Acute Toxicity: oral
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:
- 1 988
- 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
- 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
Constituent 1
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:
- other: 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. Afterwa
- 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
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