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Registration Dossier
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EC number: 203-808-3 | CAS number: 110-85-0
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Das Hirnstrombild vor und nach Kurzzeitbehandlung der Enterobiasis mit Piperazinderivaten.
- Author:
- Padelt B, Bruhn B, Nicolai A
- Year:
- 1 966
- Bibliographic source:
- Pediatr. Grenzgeb 5: 1-9
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- acute toxicity: oral
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- EEG was measured in children administered piperazine.
- GLP compliance:
- no
Test material
- Reference substance name:
- Piperazine
- EC Number:
- 203-808-3
- EC Name:
- Piperazine
- Cas Number:
- 110-85-0
- Molecular formula:
- C4H10N2
- IUPAC Name:
- piperazine
Constituent 1
Method
- Type of population:
- other: children
- Ethical approval:
- not specified
- Route of exposure:
- oral
- Reason of exposure:
- other: medical treatment
- Details on exposure:
- Piperazine has been used as an antihelmintic agent. 89 children that were adminitered doses of 90 -130 mg/kg piperazine in two doses during one day, were studied by EEG one day after treatment.
Results and discussion
- Clinical signs:
- No clinical signs
- Results of examinations:
- Results of examinations
16 of 89: no EEG changes
40 of 89: minor changes, within the normal range for age
33 of 89: Clear EEG changes, either epileptiform or increase in low-frequency waves.
in 16 of 89 also hyperventilation - provocation: in 13 of 16 clear increase in low-frequency waves and voltage increase. Allegedly no relationship with the type or seriousness of preceding infectious disease could be established.
Applicant's summary and conclusion
- Conclusions:
- Based on this report a LOAEL of 110 mg/kg for neurotoxicity in humans is proposed.
- Executive summary:
Piperazine has been used as an antihelmintic agent. 89 children that were adminitered doses of 90 -130 mg/kg piperazine in two doses during one day, were studied by EEG one day after treatment. In 33 of 89 children there were clear EEG changes, either epileptiform or increase in low-frequency waves. Based on this report a LOAEL of 110 mg/kg for neurotoxicity in humans is proposed.
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