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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
3 131 mg/kg bw/day
Additional information

In a 2-generation study in rat (dose levels 0, 0.5, 1.5 and 5% w/w) according to OECD 416, the NOAEL for effects on F0 and F1 parental animals was 1.5% w/w, based on increased absolute and relative kidney weight. For F0 parental males and females, this is equivalent to 939 and 1039 mg/kg bw/day, respectively, and for F1 parental males and females to 1305 and 1422 mg/kg bw/day,respectively. The NOAEL for effects on offspring was also 1.5% w/w, based on reduced absolute and relative spleen weight of F1 offspring. The NOAEL for effects on reproduction was ≥5% w/w; based on compound intake by F0 parental males and females (worst case), this is equivalent to ≥3131 and ≥3496 mg/kg bw/day, respectively.

Short description of key information:

Conclusions for Monosodium glutamate are based on one reproduction study (according to OECD 416 and GLP) in rats.

Effects on developmental toxicity

Description of key information

Conclusions for Monosodium glutamate are based on a prenatal developmental toxicity study (according to OECD 414 and GLP) in rats.

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
3 019 mg/kg bw/day
Additional information

In a study according to OECD 414 (deviation: administration from day 6-20 of gestation instead of day 5-20), no adverse effects of administration of monosodium L-glutamate monohydrate produced by a new method in the diet at 0.5, 1.5 and 5% w/w (equivalent 302, 898 and 3019 mg a.s./kg bw/day), no treatment related adverse effects were seen on the health of the dams and on all of the reproductive and foetal parameters examined. In conclusion, the NOAEL for maternal and developmental toxicity was ≥5% w/w in the diet equivalent to ≥3019 mg a.s./kg bw/day.

Justification for classification or non-classification

Based on the information in the discussion mentioned above, the substance is not classified for reproductive toxicity according to DSD and CLP.

Additional information