N-potassium phthalimide

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 J check

Data source

Reference

Reference Type:

other: Authoritive database

Title:

Single Dose Oral Toxicity Phthalimide in rat

Author:

Authorities of The Law, Ministry of Health, Labour and Welfare, Ministry Of Economy, Trade and Industry, and Ministry of the Environment

Year:

2017

Bibliographic source:

National Institute of Technology and Evaluation

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Acute Oral Toxicity of Phthalimide in rat

GLP compliance:

not specified

Test type:

other: No data

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pthalimide

IUPAC Name:

Pthalimide

Constituent 2

Reference substance name:

Phthalimide

EC Number:

201-603-3

EC Name:

Phthalimide

Cas Number:

85-41-6

Molecular formula:

C8H5NO2

IUPAC Name:

1H-isoindole-1,3(2H)-dione

Details on test material:

- Name of test material: Pthalimide
- Molecular formula: C8H5NO2
- Molecular weight: 147.133 g/mol
- Substance type: Organic
- Physical state: White powder
- Purity: 99.9%
- Impurities (identity and concentrations): 0.01%

Specific details on test material used for the study:

- Name of test material (as cited in study report): Phthalimide
- Molecular formula (if other than submission substance): C8H5NO2
- Molecular weight (if other than submission substance): 147.133 g/mole
- Substance type: Organic
- Physical state: White powder
Purity 99.9%
- Impurities (identity and concentrations): 0.01%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1 %

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0 and 2000 mg/kg bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: 1 % Carboxymethylcellulose sodium

Doses:

0 and 2000 mg/kg bw

No. of animals per sex per dose:

Total : 20
0 mg/kg bw: 5 male, 5 female
2000 mg/kg bw: 5 male, 5 female

Control animals:

yes

Details on study design:

- Duration of observation period following administration: No data available
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology and histopathology were examined.

Statistics:

No data available

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No effect on survival, Clinical signs, Body weight, Gross pathology and Histopathology

Mortality:

No mortality was observed in treated male and female rats at 2000 mg/kg bw

Clinical signs:

other: No effects on general appearance of treated male and female rats were observed.

Gross pathology:

No gross pathological changes were observed in treated male and female rats at 2000 mg/kg bw

Other findings:

Histopathology:
No histopathological changes were observed in treated male and female rats at 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

LD50 was considered to be > 2000 mg/kg bw when rat were treated phthalimide orally by gavage

Executive summary:

In a Single Dose acute oral toxicity study,Crj:CD (SD) male and female rats were treated with phthalimide in the concentration of 2000 mg/kg bw in 1 % Carboxymethylcellulose sodium orally by gavage. No mortality was observed in treated male and female rats at 2000 mg/kg bw. Similarly, No effects on general appearance and Body weight of treated male and female rats were observed at 2000 mg/kg bw. In addition, No gross pathological and histopathological changes were observed in treatedmale and female rats at 2000 mg/kg bwTherefore,LD50 was considered to be > 2000 mg/kg bw when rat were treatedphthalimide orally by gavage.