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Safety evaluation of INFAT® PLUS: Acute, genetic, teratogenic, and subchronic (90-day) toxicity studies
Arava Lavie1, Zhen Liu2, Jeffrey A Pitt3
1IFF Health, Migdal Haemeq, Israel.
Insights
INFAT®PLUS, a specialized infant formula ingredient, demonstrated no toxicity in comprehensive safety studies. These findings support its safe use in infant nutrition.
Area of Science:
- Food Science and Technology
- Toxicology
- Pediatric Nutrition
Background:
- INFAT®PLUS is a fat ingredient enriched with sn-2 palmitate for infant formula.
- Ensuring the safety of ingredients used in infant nutrition is paramount.
Purpose of the Study:
- To conduct a comprehensive toxicological assessment of INFAT®PLUS according to Chinese Food Safety standards (GB-15193).
- To confirm the safety of INFAT®PLUS for use in infant formula.
Main Methods:
- Acute oral toxicity tests in ICR mice and SD rats.
- A 90-day subchronic oral toxicity study in SD rats.
- In vitro and in vivo genotoxicity tests (Ames test, micronucleus test, chromosome aberration test).
- Teratogenicity evaluations in pregnant SD rats.
Main Results:
- Acute oral LD50 values were high, exceeding 53.4 g/kg BW (mice) and 26.7 g/kg BW (rats).
- No treatment-related adverse effects or mortality were observed in the 90-day study, establishing a no-observed-adverse-effect level (NOAEL) of 8.90 g/kg BW.
- Genotoxicity tests were negative, indicating no mutagenic or clastogenic potential.
- Teratogenicity studies showed no adverse effects on dams or fetuses, with a NOAEL of 8.90 g/kg BW.
Conclusions:
- INFAT®PLUS was found to be non-toxic under the tested experimental conditions.
- The comprehensive safety data supports the use of INFAT®PLUS in infant nutrition.
- INFAT®PLUS is a safe ingredient for infant formula applications.
Abstract:
INFAT®PLUS, is a sn-2 palmitate enriched fat ingredient intended for infant formula. A battery of toxicological studies was conducted in accordance with the Food Safety Toxicological Assessment GB-15193 (China), to confirm the safety of INFAT®PLUS. In the acute oral toxicity test, the LD50 of INFAT® PLUS was higher than 53.4 g /kg BW and 26.7 g/kg BW for ICR mice and SD rats, respectively. In a subchronic study, INFAT® PLUS was administered by oral gavage to SD rats with maximal daily dose of 8.90 g/kg BW for 90 days. No treatment-related clinical signs or mortalities were observed. The no-observed-adverse-effect level (NOAEL) was set at 8.90 g/kg BW. Similarly, no evidence of genotoxicity effect was noted in several in vitro and in vivo tests, including bacterial reverse mutation (Ames) test, mouse erythrocyte micronucleus test, and chromosome aberration test of mouse spermatogonia/spermatocyte. For the teratogenic evaluations, no toxicological signs were observed in both pregnant SD rat and fetuses, and the NOAEL of INFAT® PLUS was determined to be 8.90 g/kg BW. Based on the obtained results we concluded that INFAT® PLUS was found non-toxic under the experimental conditions, and the totality of the safety data supports its use for infant nutrition.
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