Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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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:
1966
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

Constituent 1
Chemical structure
Reference substance name:
Piperazine
EC Number:
203-808-3
EC Name:
Piperazine
Cas Number:
110-85-0
Molecular formula:
C4H10N2
IUPAC Name:
piperazine

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.