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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Test methods and performance uncertain, limited documentation available.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1977

Materials and methods

Principles of method if other than guideline:
The acute oral toxicity of glycine in mice was investigated.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: dd
Sex:
male/female
Details on test animals and environmental conditions:
Age at study initiation: at 5 weeks of age
Weight at study initiation: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±2 °C
- Humidity (%): 55±5°C
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
physiological saline
Details on oral exposure:
Manufacture, supplier, source of supply: Iwai Chemicals Co.
Lot/batch No.: no data
Doses:
more than 4 doses (unspecified)
No. of animals per sex per dose:
5 - 10 animals/dose
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 7 days
Frequency of observations and weighing: no data
Necropsy of survivors performed: yes
Other examinations performed: clinical signs
Statistics:
Litchfield-Wilcoxon method

Results and discussion

Preliminary study:
no data
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
4 920 mg/kg bw
95% CL:
> 4 413 - < 5 486
Sex:
male
Dose descriptor:
LD50
Effect level:
5 640 mg/kg bw
95% CL:
> 5 036 - < 6 317
Mortality:
no data
Clinical signs:
Decrease in in locomotor activity, slightly respiratory depression, piloerection and ptosis were observed in female and male mice at 15 to 35 min after dosing. Most of the animals stopped breathing after muscle weakness, cyanosis, circular movement, tonic convulsion. Some animals stopped breathing after coma without tonic convulsion. But some mice became a coma and caused breathing to stop without tonic convulsion.
Body weight:
no data
Gross pathology:
Congestion in lungs and dot hemorrhage in glandular stomach were observed in some animals. No abnormal gross findings in the other organs were observed.
Other findings:
Organ weights: No data
Histopathology: No data
Potential target organs: No data
Other observations: No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified