Registration Dossier
Registration Dossier
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EC number: 208-253-0 | CAS number: 518-47-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer- reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- A Review of the Toxicity of Twelve Fluorescent Dyes Used for Water Tracing
- Author:
- P.L. Smart
- Year:
- 1 984
- Bibliographic source:
- The NSS Bulletin, Volume 46 Number 2: 21-33 - October 1984, A publication of the National Speleological Society
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Study is conducted to check the LD50 of Sodium fluorescein after oral administration in mice
- GLP compliance:
- not specified
- Test type:
- other: No data
- Limit test:
- no
Test material
- Reference substance name:
- Sodium fluorescein
- IUPAC Name:
- Sodium fluorescein
- Reference substance name:
- Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate
- EC Number:
- 208-253-0
- EC Name:
- Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate
- Cas Number:
- 518-47-8
- Molecular formula:
- C20H12O5.2Na
- IUPAC Name:
- disodium 3-oxo-3H-spiro[2-benzofuran-1,9'-xanthene]-3',6'-diolate
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material (as cited in study report): Sodium Fluorescein
- Molecular formula (if other than submission substance): C20H10O5.2Na
- Molecular weight (if other than submission substance): 376.28
- Substance type: Organic
- Physical state: Solid
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- No data available
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- Duration of observation period following administration: 14 days (or other?): 14 days
- Statistics:
- No data available
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 4 740 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50 % mortality observed
- Mortality:
- No data
- Clinical signs:
- other: No data
- Gross pathology:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 was considered to be 4740 mg/kg bw when mice were treated with Sodium fluorescein orally.
- Executive summary:
In a acute oral toxicity study, mice were treated with Sodium fluoresce in the concentration of 4740 mg/kg bw. 50 % mortality was observed in treated mice at 4740 mg/kg bw. Therefore, LD50 was considered to be 4740 mg/kg bw when mice were treated with Sodium fluorescein orally.
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