Tripiperazine dicitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

1,4-Di (D-glycosyl) pipeazine derivatives as Oxyuricidal Agents

Author:

Telis A. Martin, Pauls S. Prickit, Allan G. Wheeler, and Howard R. Williams. Jr.

Year:

1963

Bibliographic source:

Journal of Medicinal Chemistry. Vol.6, Pg. 336

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as below

Principles of method if other than guideline:

Acute oral toxicity study was conducted by using Piperazine citrate

GLP compliance:

not specified

Test type:

other: No data

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tripiperazine dicitrate

EC Number:

205-622-8

EC Name:

Tripiperazine dicitrate

Cas Number:

144-29-6

Molecular formula:

C6H8O7.3/2C4H10N2

IUPAC Name:

piperazine 2-hydroxypropane-1,2,3-tricarboxylate (3:2) (salt)

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Piperazine citrate - Molecular formula: C12H30N6•Cl2H16O14 - Molecular weight: 642.76 g/mole - Substance type: Organic - Physical state: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Piperazine citrate - Molecular formula: C12H30N6•Cl2H16O14 - Molecular weight: 642.76 g/mole - Substance type: Organic - Physical state: Solid

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: HCl + H2O

Details on oral exposure:

VEHICLE- Concentration in vehicle: 6000, 9000, 12,000 and 15000 mg/kg- Justification for choice of vehicle: HCl + H2O were used

Doses:

6000, 9000, 12,000 and 15000 mg/kg

No. of animals per sex per dose:

Total: 40 6000 mg/kg: 10 rats9000 mg/kg: 10 rats12000 mg/kg: 10 rats15,000 mg/kg: 10 rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 24 hrs and 48 hrs

Statistics:

No data available

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

11 200 mg/kg bw

Based on:

test mat.

95% CL:

>= 9 825 - <= 12 678

Remarks on result:

other: 50% mortality noted

Mortality:

All the treated mice were died after 24 and 48 hrs at 15000 mg/kg and 5 rats after 24 hr and 6 rats after 48 hr died when treated with 12000 mg/kg.

Clinical signs:

other: Ataxia, diarrhea and depression waas observed in treated rats.

Gross pathology:

No data available

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

other: not toxic

Conclusions:

LD50 was considered to be 11,200 (12,678-9,825) mg/kg when rats were exposed to Piperazine citrate orally. Thus based on this value and as per CLP classification criteria the substance does not classify as an acute oral toxicant.

Executive summary:

In acute toxicity study, rats were exposed to Piperazine citrate in the concentration 6000, 9000, 12,000 and 15000 mg/kg orally and were observed for 24 and 48 hours. All the treated rats were died after 24 and 48 hrs at 15000 mg/kg and 5 rats after 24 hr and 6 rats after 48 hr died when treated with 12000 mg/kg and Ataxia, diarrhea and depression was observed in treated rats.Therefore, LD50 was considered to be 11,200 (12,678-9,825) mg/kg when mice were exposed to Piperazine citrate orally.

According to the publication and CLP clasiification criteria the test material does not classify as an acute oral toxicant.