Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate

Endpoint summary

Description of key information

LD50 was considered to be 6720 mg/kg bw when rats were treated with Sodium fluorescein orally.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from peer-reviewed journal

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 rat

GLP compliance:

not specified

Test type:

other: no data

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

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:

Probit analysis by method of Finney

Sex:

not specified

Dose descriptor:

LD50

Effect level:

6 720 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality

Mortality:

No data

Clinical signs:

other: No data

Gross pathology:

No data available

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 was considered to be 6720 mg/kg bw when rats were treated with Sodium fluorescein orally.

Executive summary:

Ina acute oral toxicity study, rat were treated with Sodium fluorescein the concentration of 6720 mg/kg bw. 50 % mortality was observed in treated rats at 6720 mg/kg bw. Therefore, LD50 was considered to be 6720 mg/kg bw when rats were treated with Sodium fluorescein orally.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 720 mg/kg bw

Quality of whole database:

Data is Klimish 2 and from peer reviewed journal

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

Data available for target Sodium fluorescein (CAS no 5185-47-8) for acute oral toxicity are summarized as below.

In a review given by Smartet al(1984), acute oral toxicity was evaluated in rat by using Sodium fluorescein the concentration of 6720 mg/kg bw. 50 % mortality was observed in treated rats at 6720 mg/kg bw. Therefore, LD50 was considered to be 6720 mg/kg bw when rats were treated with Sodium fluorescein orally.

In a above similar study, acute oral toxicity was evaluated in mice by using Sodium fluorescein. 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.

In a study conducted by Haraet al(1998), acute oral toxicity was evaluated in human by using Fluorescein sodium in the concentration of 10ml of 2500 mg/kg in a form of ampules, which contained 5 ml of sodium fluorescein each, were opened and 4 grams of sugar was added to offset the bitterness of the solution to check the abnormilities of eyes. A total of 1,787 patients (2,625 eyes are included in the present study. Diabetic patients were given one teaspoonful of artificial sweetener in place of sugar. 31 patients (1.7%) experienced minimal itching, discomfort, or nausea either immediately after ingestion or 20 to 30 minutes thereafter. to check the abnormilities of eyes. A total of 1,787 patients (2,625 eyes are included in the present study. Therefore, LD0 was considered to be mg/kg when human were treated with Fluorescein sodium.

In a study conducted by Yankellet al(1997), acute oral toxicity was evaluated in CD-1 female rats by using sodium fluorescein in the concentration of 4000 – 9000mg/kg in water. When treated with 5880 and 8232 mg/kg, within 5 hours animals were died and decreased spontaneous motor activity and ataxia were observed in treated female mice. Sodium fluorescein was considered as CNS depressant. Therefore, LD50 was considered to be 4738 mg/kg when CD-1 female rats were treated with sodium fluorescein orally. 

In a above similar study, acute oral toxicity was evaluated in Carworth Farms –CF1 female mice by using sodium fluorescein in the concentration of in the concentration of 4000 – 9000mg/kg in water. No death was observed at 4738 mg/kg. Therefore, LD50 was considered to be 6721 mg/kg when Carworth Farms –CF1 female mice were treated with sodium fluorescein orally.

In a study conducted by Watsonet al(1990), acute oral toxicity was evaluated in human volunteers by using sodium fluorescein in the concentration of 10 mg of fluorescein in liquid form and being weighed. If no dose-related reactions were observed then 25 mg of fluorescein in the form of capsules. No mortality was observed in treated human volunteers. One female volunteer developed a mild urticarial rash on the extensor surfaces of her arms and legs and no other effects were observed. Therefore, LD0 was considered to be 25 mg when human volunteers were treated with sodium fluorescein orally.

In a study given byO’goshiet al(2006), acute oral toxicity was evaluated in rabbits by using sodium fluorescein in the concentration of 300 mg/kg, no effect on survival of treated rabbits were observed. Therefore, LD50 were considered to be 300 mg/kg when rabbits were treated with sodium fluorescein orally,

Thought, LD50 of 300 mg/kg is available for rabbit, no other data were given.

Thus, based on the above available data for target sodium fluorescein (CAS no 518-47-8) from peer reviewed journals is not likely to be classified as an acute oral toxicant in human, rats and mouse.

Justification for selection of acute toxicity – oral endpoint
LD50 was considered to be 6720 mg/kg bw when rats were treated with Sodium fluorescein orally.

Justification for classification or non-classification

Sodium fluorescein (CAS no 518-47-8) from peer reviewed journals is not likely to be classified as an acute oral toxicant in human, rats and mouse.