Sodium pyruvate

Endpoint summary

Description of key information

In an acute toxicity study in mice the LD50 was determined to be 3533 mg/kg bw after subcutaneous injection.

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:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

no guideline available

Principles of method if other than guideline:

The toxicity of the test item was accessed in mice by subcutaneous injection.

GLP compliance:

not specified

Species:

mouse

Strain:

not specified

Sex:

not specified

Route of administration:

other: subcutaneous injection

Vehicle:

not specified

Details on oral exposure:

The test item was applied by subcutaneous injection.

Doses:

Not specified

No. of animals per sex per dose:

Not specified

Control animals:

not specified

Details on study design:

Not specified

Statistics:

Not specified

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 533 mg/kg bw

Based on:

test mat.

Mortality:

Not specified

Clinical signs:

other: Not specified

Gross pathology:

Not specified

Interpretation of results:

GHS criteria not met

Conclusions:

The acute toxicity of the test item was accessed in mice by subcutaneous injection. The LD50 was determined to be 3533 mg/kg bw.

Executive summary:

The acute toxicity of the test item was accessed in mice by subcutaneous injection. The LD50 was determined to be 3533 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 533 mg/kg bw

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

The acute toxicity of the test item was accessed in mice by subcutaneous injection. The LD50 was determined to be 3533 mg/kg bw (reference 7.2.1 -1). Furthermore, in a repeated dose toxicity study no treatment-related effects were observed in Sprague-Dawley rats after inhalative nose-only exposure to the test item (33.9 µg/L) for 28 days, 6 hours/day, 5 days/week (reference 7.5.2 -1). In addition, pyruvic acid is approved as food additive and the WHO identified no safety concern (“Evaluation of certain food additives and contaminants, Fifty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives”, 2002). This is in accordance with Scientific opinion of the EFSA who also identified no safety concern for the intake of pyruvate (“Calcium acetate, calcium pyruvate, calcium succinate, magnesium pyruvate magnesium succinate and potassium malate added for nutritional purposes to food supplements 1, Scientific Opinion of the Panel on Food Additives and Nutrient Sources added to Food (ANS)”, 2009). In conclusion, no evidence for toxicity in humans exists. According to REACH Art. 25 in order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. Therefore, no further animal testing was performed. Based on the available data the test item was not considered to be classified for acute oral toxicity.

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.