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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:
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:
1984
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:
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

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:
No data
Body weight:
No data available
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.