Registration Dossier
Registration Dossier
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EC number: 214-046-6 | CAS number: 1074-82-4
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:
- 2 017
- 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
- Reference substance name:
- Pthalimide
- IUPAC Name:
- Pthalimide
- 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%
Constituent 1
Constituent 2
- 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.
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