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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Monosodium L-glutamate monohydrate was tested in two subacute 28-day oral toxicity tests.

Council Directive 86/609/EEC and US Redbook (according to GLP principles):

Monosodium L-glutamate monohydrate was administered (gavage) to female and male Sprague-Dawley rats. The dose was 5000 mg/kg bw/day for

29 days - 10 animals per group. No treatment related effect was observed. In conclusion, the no observed adverse effect level was 4800 mg/kg/day for females and 5100 mg/kg/day for males under the conditions of this study.

Monosodium L-glutamate monohydrate was tested in a two subchronic 90-day oral toxicity tests.

A study with rats has been performed according to OECD 408 and according to GLP principles:

Monosodium L-glutamate monohydrate was administered (gavage) to female and male Sprague-Dawley rats. The dose range was 0.5, 1.5 and 5%

(w/w) for 92 to 96 days - 20 animals per group. No treatment related effect was observed. The NOAEL was judged >3170 mg a.s./kg bw/day for males and >3620 mg a.s./kg bw/day for females under the conditions of the present study.

A study with dogs has been performed according to OECD 408 and according to GLP principles:

Monosodium L-glutamate monohydrate was administered (gavage, capsule) to female and male Beagle dogs. The dose range was 150, 500 and 1500

mg/kg bw/day for 90 to 92 days - 4 animals per group. No treatment related effect was observed. It was concluded that the NOAEL was 1500 mg/kg bw/day the highest dose tested.

No data is available on dermal or inhalation toxicity.  

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 500 mg/kg bw/day
Study duration:
subchronic
Species:
dog

Additional information

For monosodium L-glutamate oral repeated dose tests (28-d and 90-d) were available with no toxicity observed resulting in a NOAEL of 4800 mg/kg bw/d for the 28-day studies, a NOAEL of 3170 mg/kg bw/d for the 90 -d study in rats and a NOAEL of ≥1500 mg/kg for the 90 -d study in dogs.

The NOAEL of 1500 mg/kg for the 90 day study in dogs was used as key value for chemical safety assessment.

Justification for classification or non-classification

Based on the results of the subacute 28 -day and subchronic 90 -day tests, monosodium glutamate is not classified for repeated dose toxicity according to DSD and CLP.