Piperazine

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:

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

Test material information

Constituent 1

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.