Sodium hydrogen glutamate

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

No data available

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Not a relevant exposure route. Study used as supporting data.

Data source

Reference

Reference Type:

publication

Title:

Acute Toxicity of Monosodium L-glutamate in Mice and Rats

Author:

Hirofumi Moriyuki

Year:

1978

Bibliographic source:

Pharmacometrics, Volume 15, pages 433-436

Materials and methods

Principles of method if other than guideline:

No specific guideline followed.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium hydrogen glutamate

EC Number:

205-538-1

EC Name:

Sodium hydrogen glutamate

Cas Number:

142-47-2

Molecular formula:

C5H8NNaO4

IUPAC Name:

sodium hydrogen 2-aminopentanedioate

Details on test material:

- Mono sodium glutamate which was commercially available as a food additive was used in this experiment.
- Substance type: hydrated form.

Test animals

Species:

mouse

Strain:

ICR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data available
- Age at study initiation: 4 weeks
- Weight at study initiation: 18 to 23 g
- Fasting period before study: not applicable
- Housing: 10 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data available


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 50
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): no data available

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

physiological saline

Details on exposure:

MAXIMUM DOSE VOLUME APPLIED: 40 ml/kg

DOSAGE PREPARATION (if unusual): the test substance was given as a physiological saline solution

Doses:

0, 5.50, 6.00, 6.60, 7.26, 8.00, 8.80 and 9.68

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available
- Necropsy of survivors performed: no
- Other examinations performed: acute toxic of mono sodium glutamate during 2 hours after dosing

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

8.2 other: g/kg

95% CL:

>= 7.66 - <= 8.77

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

8.4 other: g/kg

95% CL:

>= 7.95 - <= 8.88

Mortality:

Dosage 5.50 g/kg: female 1/10
Dosage 7.26 g/kg: male 2/10, female 1/10
Dosage 8.00 g/kg: male 4/10, female 2/10
Dosage 8.80 g/kg: male 7/10, female 8/10
Dosage 9.68 g/kg: male 10/10, female 10/10

Clinical signs:

Acute toxic of mono sodium glutamate during 2 hours after dosing:

Dosage 4.30-6.00 g/kg: abdominal posture, palpebral closure, sedation, ataxia, twich, cyanosis
Dosage 6.12-9.68 g/kg: vocalization, stagering gait, excitation, spasm of limbs, jumping, tail elevation, tonic convulsion, death

Body weight:

Mice which escaped from acute death showed no apparent change in body weight gains at one and two weeks after dosing

Gross pathology:

No significant abnormalities were observed in the gross findings of the visceral organs at the termination of the study.

Applicant's summary and conclusion

Conclusions:

LD50 values (g/kg body weight) by subcutaneous route represented by male and female mice were 8.20 and 8.40.