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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been assessed for the use in a category approach. According to the methodology and to the extent of available details, the study has been judged as reliable with restrictions.

Data source

Reference
Reference Type:
secondary source
Title:
Evaluation of the Health Aspects of Potassium Acid Tartrate, Sodium Potassium Tartrate, Sodium Tartrate and Tartaric Acid as Food Ingredients
Author:
Federation of American Societies for Experimental Biology, Bethesda, MD
Year:
1979
Bibliographic source:
Food and Drug Administration, Washington, 1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
L-tartaric acid
IUPAC Name:
L-tartaric acid
Test material form:
not specified
Details on test material:
No details on test material identity are available.
Specific details on test material used for the study:
no data

Test animals

Species:
other: chick embryos
Strain:
not specified
Details on test animals or test system and environmental conditions:
The teratogenic potential of L(+) tartaric acid was studied in 96-hour.

Administration / exposure

Route of administration:
other:
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on exposure:
Dose levels of 8 mg per kg and above were toxic when injected into the air cell or yolk.
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Details on mating procedure:
no data
Duration of treatment / exposure:
96-hour
Frequency of treatment:
no data
Duration of test:
96-hour
Doses / concentrations
Dose / conc.:
8 other: mg/kg
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data

Examinations

Maternal examinations:
no data
Ovaries and uterine content:
no data
Fetal examinations:
no data
Statistics:
no data
Indices:
no data
Historical control data:
no data

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
not examined
Description (incidence and severity):
no data
Dermal irritation (if dermal study):
not examined
Description (incidence and severity):
no data
Mortality:
not examined
Description (incidence):
no data
Body weight and weight changes:
not examined
Description (incidence and severity):
no data
Food consumption and compound intake (if feeding study):
not examined
Description (incidence and severity):
no data
Food efficiency:
not examined
Description (incidence and severity):
no data
Water consumption and compound intake (if drinking water study):
not examined
Description (incidence and severity):
no data
Ophthalmological findings:
not examined
Description (incidence and severity):
no data
Haematological findings:
not examined
Description (incidence and severity):
no data
Clinical biochemistry findings:
not examined
Description (incidence and severity):
no data
Urinalysis findings:
not examined
Description (incidence and severity):
no data
Behaviour (functional findings):
not examined
Description (incidence and severity):
no data
Immunological findings:
not examined
Description (incidence and severity):
no data
Organ weight findings including organ / body weight ratios:
not examined
Description (incidence and severity):
no data
Gross pathological findings:
not examined
Description (incidence and severity):
no data
Neuropathological findings:
not examined
Description (incidence and severity):
no data
Histopathological findings: non-neoplastic:
not examined
Description (incidence and severity):
no data
Histopathological findings: neoplastic:
not examined
Description (incidence and severity):
no data
Other effects:
not examined
Description (incidence and severity):
no data
Details on results:
no data

Maternal developmental toxicity

Number of abortions:
not examined
Description (incidence and severity):
no data
Pre- and post-implantation loss:
not examined
Description (incidence and severity):
no data
Total litter losses by resorption:
not examined
Description (incidence and severity):
no data
Early or late resorptions:
not examined
Description (incidence and severity):
no data
Dead fetuses:
not examined
Description (incidence and severity):
no data
Changes in pregnancy duration:
not examined
Description (incidence and severity):
no data
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.DescriptionIncidenceAndSeverityEffectsOnPregnancyDuration): no data
Changes in number of pregnant:
not examined
Description (incidence and severity):
no data
Other effects:
not examined
Description (incidence and severity):
no data
Details on maternal toxic effects:
no data

Effect levels (maternal animals)

Dose descriptor:
other: not relevant
Based on:
other: not relevant
Basis for effect level:
other: not relevant
Remarks on result:
other: not relevant

Results (fetuses)

Fetal body weight changes:
not specified
Description (incidence and severity):
no data
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): no data
Reduction in number of live offspring:
not specified
Description (incidence and severity):
no data
Changes in sex ratio:
not specified
Description (incidence and severity):
no data
Changes in litter size and weights:
not specified
Description (incidence and severity):
no data
Changes in postnatal survival:
not specified
Description (incidence and severity):
no data
External malformations:
not specified
Description (incidence and severity):
no data
Skeletal malformations:
not specified
Description (incidence and severity):
no data
Visceral malformations:
not specified
Description (incidence and severity):
no data
Other effects:
effects observed, non-treatment-related
Description (incidence and severity):
The teratogenic potential of the substance L(+) tartaric acid was studied in chick embryos.
Statistical evaluation of the occurrence of abnormalities in tartaric acid treated embryos failed to indicate that the substance was teratogenic.
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No abnormalities occurs

Effect levels (fetuses)

Dose descriptor:
dose level:
Effect level:
ca. 8 other: mg/kg
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: teratogenicity
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Conclusions:
Statistical evaluation of the occurrence of abnormalities in tartaric acid treated embryos failed to indicate that the substance was teratogenic.
Executive summary:

Statistical evaluation of the occurrence of abnormalities in tartaric acid treated embryos failed to indicate that the substance was teratogenic at dose levels of 8 mg/kg and above.