Registration Dossier

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.