Registration Dossier
Registration Dossier
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EC number: 200-293-7 | CAS number: 56-86-0
Endpoint summary
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 effect 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 L-Glutamic acid are based on read-across from Monosodium glutamate (EC 205-538-1) tested in one reproduction study (according to OECD 416 and GLP) in rats.
Effects on developmental toxicity
Description of key information
Conclusions for L-Glutamic acid are based on read-across from Monosodium glutamate (EC 205-538-1) tested in one 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, an analogue substance, 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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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