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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Reference substance name:
Pthalimide
IUPAC Name:
Pthalimide
Constituent 2
Chemical structure
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:
No effects on general appearance of treated male and female rats were observed.
Body weight:
No effects on Body weight of treated male and female rats were observed at 2000 mg/kg bw
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.

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