Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-464-3 | CAS number: 819-83-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Exposure duration 33 weeks instead of 12 weeks
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium β-glycerophosphate
- EC Number:
- 212-464-3
- EC Name:
- Disodium β-glycerophosphate
- Cas Number:
- 819-83-0
- Molecular formula:
- C3H7O6P.2Na
- IUPAC Name:
- disodium β-glycerophosphate
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 220-225 g
- Fasting period before study: not specified
- Housing: individual wire cages
- Diet: ad libitum plain ground Purina rat chow
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- air-conditioned laboratory
- Photoperiod: 12 : 12 h light-dark cycle
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- - DIET PREPARATION
:
- ground Purina rat chow containing 2.5% beta-glycerophosphate.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 33 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Dose / conc.:
- 1 900 mg/kg bw/day (actual dose received)
- Remarks:
- The daily intake of beta-glycerophosphate was calculated from food consumption
- No. of animals per sex per dose:
- 9
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: not specified, recorded throughout the experiment
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
-yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY and CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of 33 weeks
- Anaesthetic used for blood collection: Yes, Nembutal
- Animals fasted: Not specified
- How many animals: all
- Blood was drawn from the femoral vein
- Parameters checked haematology: total blood counts, differential blood count and hematocrit and hemoglobin determinations.
- Parameters checked clinical Chemistry: cholesterol, triglycerides and phospholipids, serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) and serum alkaline phosphatase.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No
OTHER:
- Bile was collected under nembutal anaestetic from cannulated bile duct for two 1-h collection periods. During the two hours of bile collection the rats were infused with isotonic saline at the rate of 1 ml/h through a catheter placed in the femoral vein in order to replace the volume of collected bile.
- Parameters analyzed: cholesterol, bile acids and phospholipids.
- Cholesterol, phospholipids and triglycerides were also determined in frozed portions of Liver. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. Liver, spleen, kidneys, testes, heart and brain were
removed and weighed.
HISTOPATHOLOGY: Yes. Parts of the liver and kidneys were preserved in buffered formaline. Hematoxylin-eosin staining. - Statistics:
- Student's t-test
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Control: 2/9
Treated: 1/9 - Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Kidneys which were significantly larger in the /3-glycerophosphate-fed group (0.686 + 0.027) compared to control group (0.569 + 0.020). Attributed to hyperplasia.
Heart, brain, testes and spleen were similar in the treated and control groups. - Gross pathological findings:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Beta-glycerophosphate significantly increased the phospholipid concentrations (4.79 + 0.20 vs. 3.55 + 0.20 mtmol/ml) without
affecting the cholesterol and bile acid concentrations or the volumes of bile collections.
Liver phospholipids were significantly higher in the beta-glycerophosphate-fed rats compared to control rats (5117.0 +/- 169.6 vs. 4180.8 +/- 132.5
mg/100 g, respectively)
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 900 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Beta-glycerophosphate when given in a high dose for a prolonged period of time has no detrimental effect in rats.
- Executive summary:
Toxic effects of a high dose of orally administered disodium beta-glycerophosphate to the rat for a period of 33 weeks was determined.
Beta-glycerophosphate administration had no effect on either survival rate, body weight, hematological and liver function tests or on serum and liver lipids concentrations. All organ weights were similar in the control and experimental rats except for the kidneys which were significantly heavier in the beta-glycerophosphate-fed rats. The biliary phospholipids concentrations was significantly increased in the treated group. Histological examination of liver and kidneys did not reveal any pathological findings. These results suggest that long-term administration of beta-glycerophosphate did not induce any
toxic manifestations. The observed hyperplasia of the kidneys was attributed to the effect of the sodium content of beta-glycerophosphate.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
