Sodium ascorbate

Endpoint summary

Description of key information

The acute toxicity was investigated in 5 studies, 3 using rats and 2 using mice that received either a single dose or were treated on five consecutive days. No signs of toxicity were seen in any of the studies. The LD50 values were > 11,000 mg/kg bw in the rat and > 9,400 mg/kg bw in the mouse.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

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

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

Specific details on test material used for the study:

CAS number: 134-03-2

Species:

rat

Strain:

not specified

Sex:

not specified

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.

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

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.

Reference 2

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

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: not available

Specific details on test material used for the study:

CAS number: 134-03-2

Species:

mouse

Strain:

not specified

Sex:

not specified

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.

Sex:

not specified

Dose descriptor:

LD50

Effect level:

9 400 mg/kg bw

Based on:

test mat.

95% CL:

>= 7 980 - <= 10 880

Remarks on result:

other: after 15 days

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 9,400 mg/kg.

Executive summary:

In mice 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 9,400 mg/kg. The observation period was15 days (Hoffmann-La Roche, 1976). The result of this repeated dose study can be used in a weight of evidence approach to assess the acute oral toxicity of the test substance.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Not to present GL, minimal reporting standard (no details, symptoms etc.), not GLP, CAS number, source, purity, known impurities are missing, strain, source, age, weight and housing conditions of rats not given, observation only 10 d

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

pre-guideline study, i.e. no guideline was available at the time of the study

Principles of method if other than guideline:

Studies were conducted before the OECD Guidelines for the testing of chemicals were established.
Ten mice per dose group were used. Animals received the test item at different doses orally by gavage and were monitored for ten days. LD10, LD50, and LD90 values were calculated.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Specific details on test material used for the study:

Identification: Sodium ascorbate crystalline
CAS number: 134-03-2
Batch Number: TL00910581
Purity: >99 %
Appearance: White to yellowish crystalline powder
Expiry Date (as given by the sponsor): April 01, 2011

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

No. of animals per sex per dose:

10

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

16 300 mg/kg bw

Based on:

test mat.

95% CL:

>= 14 700 - <= 18 800

Remarks on result:

other: after 10 days

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.

Executive summary:

The oral LD₅₀ in the rat was 16,000 mg/kg in a poorly documented pre-guideline study (Hoffmann-La Roche, 1973). The result can be used in a weight of evidence approach.

Reference 4

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Not to present GL, minimal reporting standard (no details, symptoms etc.), not GLP, CAS number, source, purity, known impurities are missing, strain, source, age, weight and housing conditions of rats not given, observation only 10 d

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

pre-guideline study, i.e. no guideline was available at the time of the study

Principles of method if other than guideline:

Studies were conducted before the OECD Guidelines for the Testing of Chemicals were established.
Ten mice per dose group were used. Animals received the test item at different doses orally by gavage and were monitored for ten days. LD10, LD50, and LD90 values were calculated.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

other: not avaialble

Specific details on test material used for the study:

CAS number: 134-03-2

Species:

mouse

Strain:

not specified

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

No. of animals per sex per dose:

10

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

17 531 mg/kg bw

Based on:

test mat.

95% CL:

>= 14 960 - <= 20 102

Remarks on result:

other: after 10 days

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.

Executive summary:

The oral LD₅₀ in the mouse was 17,531 mg/kg in a poorly documented pre-guideline study (Hoffmann-La Roche, 1973). The result can be used in a weight of evidence approach.

Reference 5

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: equivalent or similar to OECD 401

Remarks:

Not to present GL, minimal reporting standard (no details, symptoms etc.), not GLP, CAS number, source, purity, known impurities are missing, strain, source, age, weight and housing conditions of rats not given, not single application

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

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 (4, 8, or 16 g/kg bw/d) orally by gavage once daily on five consecutive days. Bodyweight was measured and the animals were monitored for a total of 15 days. LD10, LD50, and LD90 values were calculated.

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Specific details on test material used for the study:

CAS Number: 134-03-2

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

11 289 mg/kg bw

Based on:

test mat.

95% CL:

>= 10 390 - <= 12 188

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 > 11,000 mg/kg.

Executive summary:

In rats receiving sodium ascorbate by oral gavage on five consecutive days, the LD₅₀ was > 11,000 mg/kg; the observation period was15 days (Hoffmann-La Roche, 1971). The result of this study can be used in a weight of evidence approach.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

11 000 mg/kg bw

Quality of whole database:

Reporting is limited but results are comparable across the studies. The results indicate in a weight of evidence approach that the substance is not acutely toxic.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item is not classified for acute toxicity oral, acute toxicity inhalation or acute toxicity dermal according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.