Sodium ascorbate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

equivalent or similar to OECD 401; not to present GL, minimal reporting standard, not GLP, CAS number, source, purity, known impurities, lot number are missing, strain, age and housing conditions of rats not given, not single application

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

pre-guideline study

Principles of method if other than guideline:

Studies were conducted before the OECD Guidelines for the Testing of Chemicals were established.
Mice and rats were used in the experiments. Animals received the test item at doses of (2.5, 5, 10, or 20 g/kg bw/d) orally by gavage once daily on five consecutive days. Bodyweight gain was measured and the animals were monitored for a total of 15 days. LD10, LD50, and LD90 values were calculated.

GLP compliance:

no

Test type:

other: no data

Test material

Test material information

Constituent 1

Reference substance name:

Sodium ascorbate

EC Number:

205-126-1

EC Name:

Sodium ascorbate

Cas Number:

134-03-2

Molecular formula:

C6H8O6.Na

IUPAC Name:

sodium ascorbate

Specific details on test material used for the study:

CAS number: 134-03-2

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

animals were dosed on five consecutive days.

Doses:

20.000,
10.000,
5.000,
2.500 mg/kg bw

Control animals:

not specified

Details on study design:

Observation period was 15 days.

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

14 100 mg/kg bw

Based on:

test mat.

95% CL:

>= 13 000 - 15 200

Remarks on result:

other: after 15 days

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The results of the acute toxicity studies do not meet the classification criteria for acute oral toxicity as the LD50 was determined to be 14,100 mg/kg.

Executive summary:

In rats receiving sodium ascorbate by oral gavage on five consecutive days at dose levels of 2,500, 5,000, 10,000 and 20,000 mg/kg/day, the LD50 was 14,100 mg/kg. The observation period was15 days (Hoffmann-La Roche, 1976). The result of this study repeated dose study can be used in a weight of evidence approach to assess the acute oral toxicity of the test substance.