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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:
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: Scientifically acceptable publication.

Data source

Reference
Reference Type:
publication
Title:
Das Hirnstrombild vor und nach Kurzzeitbehandlung der Enterobiasis mit Piperazinderivaten.
Author:
Padelt B, et al
Year:
1966
Bibliographic source:
As cited in EC Riskassessment report for Piperazine, vol. 56, 2005

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 on children administered piperazine.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
none

Method

Subjects:
Children
Ethical approval:
not applicable
Route of exposure:
oral
Reason of exposure:
other: medical treatment
Examinations:
Piperazine has been used as an antihelmintic agent. 89 children that were administered doses of 90 -130 mg/kg bw 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 EEC changes.
40 of 89: minor changes, within the normal range for age.
33 of 89: Clear EEC 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 bw for neurotoxicity in humans is proposed.
Executive summary:

Piperazine has been used as an antihelmintic agent. 89 children that were administered doses of 90 -130 mg/kg bw piperazine in two doses during one day, were studied by EEG one day after treatment. In 33 of 89children there were clear EEC 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.