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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:
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:
2004
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

Constituent 1
Chemical structure
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
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:
No data available
Body weight:
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.