Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: SIDS
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
SIDS for L-Glutamic acid
Author:
OECD
Year:
2013
Report Date:
2013
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

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
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Specific details on test material used for the study:
Test material equivalent to submission substance identity:
yes

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: male 48~5 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: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (℃): 21
- Humidity (%): 55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tragacanth

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Remarks on result:
other: no mortality and body weight changes were observed
Mortality:
After the observation period none of the animals died after dosing of 5,110 mg/kg.
Clinical signs:
No signs of toxicity was observed at the animals after dosing of 5,110 mg/kg

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
L-Glutaminic acid is not classified as toxic via oral route.