Registration Dossier
Registration Dossier
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EC number: 248-962-2 | CAS number: 28319-77-9
Acute Toxicity: oral
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:
- abstract
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety assessment of AGPC as a food ingredient
- Author:
- Brownawell AM, Carmines EL, Montesano F
- Year:
- 2 011
- Bibliographic source:
- Food Chem Toxicol. 2011 June;49(6):1303-15
Materials and methods
Test guideline
- Guideline:
- other: No information available from the abstract
- GLP compliance:
- not specified
- Remarks:
- Information not available from the abstract
Test material
- Reference substance name:
- Choline glycerophosphate
- EC Number:
- 248-962-2
- EC Name:
- Choline glycerophosphate
- Cas Number:
- 28319-77-9
- Molecular formula:
- C8H20NO6P
- IUPAC Name:
- bis(2-hydroxy-N,N,N-trimethylethanaminium) 2,3-dihydroxypropyl phosphate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- LD50
- Effect level:
- >= 10 000 mg/kg bw
- Mortality:
- Deaths were preceded by convulsions in some animals.
- Clinical signs:
- Dosing of dogs with up to 3000 mg/kg of the test item resulted only in reduced activity. Sub-chronic and chronic oral toxicity studies in rats (up to 1000 mg/kg/day) and beagles (up to 300 mg/kg/day) produced symptomology primarily consisting of reduced activity; slight decreases in food consumption and body weight gain; and slight reduction in liver weight, paralleled by significant decreases in plasma triglycerides, bilirubin, and alkaline phosphatase. There were no histopathological correlates.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results, choline glycerophosphate has no mutagenic activity, is not genotoxic in vitro or in vivo, exhibits low acute oral toxicity, has a LD50 >= 10000 mg/kg in rats and mice and has an oral NOAEL of 150 mg/kg bw/day following 26 weeks oral exposure.
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