Registration Dossier

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: Basic information provided.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1999

Materials and methods

Principles of method if other than guideline:
Ten fasted albino rats were administered >5000 mg/kg of sodium erythorbate in a 50% aqueous suspension. Clinical observations were noted at 3, 5 and 24 hrs post-dosing.
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
- Name of test material (as cited in study report): Sodium Erythorbate
- Physical state: 50% aqueous suspension

Test animals

Species:
rat
Strain:
other: albino
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Clinical signs:
The treated rats had soft, pasty stools within 3 hrs of dosing, followed in 2 hrs by marked diarrhea that persisted for 24 hrs.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 was >5000 mg/kg bw in this study.
Executive summary:

In an acute oral toxicity study, 10 fasted albino rats were given a single oral dose of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone in a 50% aqueous suspension at a doses of 5000 mg/kg bw.

Oral LD50 = > 5000 mg/kg bw

The treated rats had soft, pasty stools within 3 hrs of dosing, followed in 2 hrs by marked diarrhea that persisted for 24 hrs.