Registration Dossier

Administrative data

Description of key information

Oral: Hazard assessment is based on the weight of evidence from all available studies.

LD50 (oral) rat, male/female: 9550/7930 mg/kg bw

LD50 (oral) mice, male/female: 5640/4920 mg/kg bw

Inhalation:

No study required since exposure of humans via inhalation is unlikely based on the low vapour pressure, MMAD and exposure considerations. No hazard is expected based on the available data on the acute oral toxicity.

Dermal:

No study required since exposure of humans via skin is unlikely based on QSAR predictions with the available data on the physico-chemical properties of the substance. However, systemic toxic effects after acute dermal exposure are unlikely to occur based on the available data on the acute oral toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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.
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
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
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
Preliminary study:
no data
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
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
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.
Principles of method if other than guideline:
The acute oral toxicity of glycine in rats was investigated.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Age at study initiation: at 7 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
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
Preliminary study:
no data
Sex:
female
Dose descriptor:
LD50
Effect level:
7 930 mg/kg bw
95% CL:
> 7 329 - < 8 580
Sex:
male
Dose descriptor:
LD50
Effect level:
9 550 mg/kg bw
95% CL:
> 8 917 - < 10 228
Mortality:
no data
Clinical signs:
Decrease in in locomotor activity, slightly respiratory depression, piloerection and ptosis were observed in female and male rats 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 rats 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
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises studies which each alone are regarded insufficient for assessment (Klimisch score 4). However, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity of glycine was investigated in male and female Wistar rats and DD mice. Five to ten animals were orally administered with a single dose of the test substance dissolved in physiological saline. The test doses were unspecified (more than 4 doses). The animals were observed for 7 days after administration. No data regarding mortalitiy and body weight development were given. Clinical signs of toxicity included a decrease in locomotor activity, slightly respiratory depression, piloerection and ptosis in female and male rats at 15 to 35 min after dosing. Most of the animals stopped breathing after muscle weakness, cyanosis, circular movement and tonic convulsion. Some rats became a comatose and stopped breathing without tonic convulsion. At 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. The oral LD50 in rats was estimated to be 9550 and 7930 mg/kg for males and females, respectively. For mice, the oral LD50 was estimated to be 5640 and 4920 mg/kg for males and females, respectively.

No data on acute inhalation and dermal toxicity is available.

Furthermore, intravenous and subcutaneous administration of glycine to rats revealed LD50 values of 2600 and 5240 mg/kg bw, respectively. Intravenous, subcutaneous and intraperitoneal application of glycine to mice resulted in LD50 values of 2510, 5480 and 4550 mg/kg bw, respectively.

Justification for classification or non-classification

The available data on acute oral toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

No data is available for acute dermal and inhalation toxicity.