Registration Dossier
Registration Dossier
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EC number: 204-052-7 | CAS number: 114-70-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Centre for drug evaluation and research, Pharmacological review
- Author:
- FDA
- Year:
- 2 004
- Bibliographic source:
- Centre for drug evaluation and research pharmacological review application no 21-060, 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity study of sodium phenylacetate was performed in Rat
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium phenylacetate
- EC Number:
- 204-052-7
- EC Name:
- Sodium phenylacetate
- Cas Number:
- 114-70-5
- Molecular formula:
- C8H7NaO2
- IUPAC Name:
- sodium 2-phenylacetate
- Test material form:
- solid
- Details on test material:
- - Name( IUPAC): sodium 2-phenylacetate
- Name of test material (as cited in study report): Sodium phenylacetate
- Molecular formula C8H8O2.Na
- Molecular weight: 158.1313 g/mol
- Smiles notation : c1(ccccc1)CC(=O)[O-].[Na+]
- InChl: 1S/C8H8O2.Na/c9-8(10)6-7-4-2-1-3-5-7;/h1-5H,6H2,(H,9,10);/q;+1/p-1
- Substance type: Organic
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- Name( IUPAC): sodium 2-phenylacetate
- Name of test material (as cited in study report): Sodium phenylacetate
- Molecular formula C8H8O2.Na
- Molecular weight: 158.1313 g/mol
- Smiles notation : c1(ccccc1)CC(=O)[O-].[Na+]
- InChl: 1S/C8H8O2.Na/c9-8(10)6-7-4-2-1-3-5-7;/h1-5H,6H2,(H,9,10);/q;+1/p-1
- Substance type: Organic
- Physical state: Liquid
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- Male :3150mg/kg and female :2860mg/kg
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 150 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 860 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed
- Mortality:
- 50% mortality was observed
- Clinical signs:
- other: No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- LD50 was considered to be in male: 3150mg/kg and female: 2860mg/kg body weight. When male and female rats were treated with sodium phenylacetate (114-70-5) orally.
- Executive summary:
Acute oral toxicity study was done in rat using test materialsodium phenylacetate (114-70-5).50% mortality was observed at dose inmale: 3150mg/kg and female: 2860mg/kg body weight. HenceLD50 was considered to be in male: 3150mg/kg and female: 2860mg/kg body weight. When male and female rats were treated withsodium phenylacetate (114-70-5) orally.
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