Registration Dossier

Administrative data

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:
Not specified
Body weight:
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.