N-(4-chlorobenzhydryl)piperazine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

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:

Pharmacological Properties of Two New Antihistaminics of Prolonged Action

Author:

S. Y. PAN, J. F. GARDOCKI, and J. C. REILLY

Year:

1954

Bibliographic source:

Journal of the American Pharmaceutical Association, Scientific Edition. Vol. 43, Pg. 653, 1954

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute Oral toxicity test was carried out to study the effects of buclizine (82-95-1) on mice.

GLP compliance:

not specified

Test type:

other: no data available

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Buclizine

EC Number:

201-448-1

EC Name:

Buclizine

Cas Number:

82-95-1

Molecular formula:

C28H33ClN2

IUPAC Name:

1-[(4-tert-butylphenyl)methyl]-4-[(4-chlorophenyl)(phenyl)methyl]piperazine

Details on test material:

- Name of test material (IUPAC name): 1-[(4-tert-butylphenyl)methyl]-4-[(4-chlorophenyl)(phenyl)methyl]piperazine
- Common name: Buclizine
- Molecular formula: C28H33ClN2
- Molecular weight: 433.0357 g/mol
- Smiles notation: CC(C)(C)c1ccc(cc1)CN2CCN(CC2)C(c3ccccc3)c4ccc(cc4)Cl
- InChl: 1S/C28H33ClN2/c1-28(2,3)25-13-9-22(10-14-25)21-30-17-19-31(20-18-30)27(23-7-5-4-6-8-23)24-11-15-26(29)16-12-24/h4-16,27H,17-21H2,1-3H3
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material (as cited in study report):buclizine
- Molecular formula :C28H33ClN2
- Molecular weight :433.0357 g/mol
- Substance type:organic

Test animals

Species:

mouse

Strain:

other: albino Swiss

Sex:

male

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Weight at study initiation: 17 to 23 gm

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

No data available

Doses:

2100 mg/kg bw

No. of animals per sex per dose:

No data available

Control animals:

not specified

Details on study design:

Details on study design:
- Other examinations performed: clinical signs

Statistics:

Litchfield and Wilcoxon

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

2 100 mg/kg bw

Based on:

test mat.

95% CL:

1 824 - 2 394

Remarks on result:

other: 50% mortality was observed

Mortality:

50% mortality was observed at dose 2100 mg/kg bw

Clinical signs:

other: Clinical signs like respiratory distress followed by excitement,Convulsions were observed.

Gross pathology:

No data available

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The lethal concentration (LD50) value for acute oral toxicity test was considered to be 2100 mg/kg bw ,when male albino Swiss mice were treated with buclizine (82-95-1)orally.

Executive summary:

Acute oral toxicity study was done in male albino Swiss mice weighing from 17 to 23 gm using test material buclizine(82-95-1).The LD50 and 95% confidence limits were determined according to the method of Litchfield and Wilcoxon.50% mortality was observed at dose 2100 mg/kg bw.Clinical signs like respiratory distress followed by excitement,convulsions were observed.Hence,LD50 value was considered to be 2100 mg/kg bw (95% CL 1824-2394),when mice were treated with buclizine(82-95-1)orally.