Registration Dossier
Registration Dossier
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EC number: 266-113-4 | CAS number: 66071-94-1 Substance obtained by the partial removal of water from the liquid resulting from steeping corn in a water and sulphur dioxide solution which is allowed to ferment by the action of naturally occurring lactic acid-producing microorganisms.
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1989
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Subchronic Oral toxicity study of Calcium lactate in F344 rats
- Author:
- Matsushima Y, Onodera H et al
- Year:
- 1 989
- Bibliographic source:
- Eisei Shikenjo Hokuku 107: 78-83 (1989) cited in HPV Data Set Lactic Acid CAS # 50-21-5 Dossier number 50215
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Calcium dilactate
- EC Number:
- 212-406-7
- EC Name:
- Calcium dilactate
- Cas Number:
- 814-80-2
- IUPAC Name:
- calcium bis(2-hydroxypropanoate)
- Details on test material:
- - Name of test material (as cited in study report): Calcium lactate as a salt of lactic acid.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: Oral (experiment I: drinking water; experiment II: diet)
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5, 2.5, 1.25, 0.6, 0.3 %
Basis:
no data
- No. of animals per sex per dose:
- 5, 2.5, 1.25, 0.6, 0.3 %
- Control animals:
- yes, concurrent no treatment
Results and discussion
Effect levels
- Dose descriptor:
- other: no data
- Basis for effect level:
- other: Study summary does not contain results
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
A <10 % decrease in body weight gain. All animals survived. Some haematological and biochemical parameters changed, but no severe lesions were found in microscopic examination in the experiment with calcium lactate mixed in the diet, the amount of calcium in the urine was significantly increased. Nephrocalcinosis and degeneration in kidneys observed. Indications that Nephrocalcinosis was dependent on the low Calcium/Phosphorus ratio of the synthetic diet.
Applicant's summary and conclusion
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