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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 14 - April 04, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to EC guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Intercomparison Study on the Determination of Single Administration Toxicity in Rats, Commission of the European Communities, Health and Safety
Directorate, J. Assoc. Off. Anal. Chem. 62, 864-873, 1979
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Glutamic acid
EC Number:
200-293-7
EC Name:
Glutamic acid
Cas Number:
56-86-0
Molecular formula:
C5H9NO4
IUPAC Name:
glutamic acid
Details on test material:
- Name of test material (as cited in study report): L-Glutaminsaure
- Physical state: white powder
- Stability under test conditions: no data available
- Storage condition of test material: no data available

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: male 48-55 days, female 62 days
- Weight at study initiation: male 129-166 g, female 131-141 g
- Fasting period before study: 16 hours
- Housing: individually in makrolon cages type II
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tragacanth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 238 mg/ml
- Amount of vehicle (if gavage): 0.5%
- Justification for choice of vehicle: no data available
- Lot/batch no. (if required): no data available
- Purity: no data available

MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg

DOSAGE PREPARATION (if unusual): 238 mg/ml


Doses:
5110 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
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 data available
- Other examinations performed: no data available
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Mortality:
After the observation period none of the animals died after dosing of 5110 mg/kg.
Clinical signs:
other: No signs of toxicity was observed at the animals after dosing of 5110 mg/kg.
Gross pathology:
No data available

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 value (g/kg body weight) by oral route represented by male and female rats was 5.11 g/kg bw.