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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

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

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
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.