Registration Dossier
Registration Dossier
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EC number: 203-740-4 | CAS number: 110-15-6
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Possible estrogenic properties of succinic acid and effects on reproductive organs were investigated.
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- bevore 1944
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Old study with methodological deficiences.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Injections of certain plant growth substances in rats and chick embryos.
- Author:
- Dye W.S.
- Year:
- 1 944
- Bibliographic source:
- Growth
- Reference Type:
- secondary source
- Title:
- EVALUATION OF THE HEALTH ASPECTS OF SUCCINIC ACID AS A FOOD INGREDIENT
- Author:
- Jackson W.L.
- Year:
- 1 975
- Bibliographic source:
- NTIS (National Technical Information Service)
- Reference Type:
- secondary source
- Title:
- SCIENTIFIC LITERATURE REVIEWS ON GENERALLY RECOGNIZED AS SAFE (GRAS) FOOD INGREDIENTS-SUCCINIC ACID
- Author:
- FDA
- Year:
- 1 973
- Bibliographic source:
- NTIS (National Technical Information Service)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Possible estrogenic properties of succinic acid were investigated in two month old ovariectomized rats by daily subcutaneous injections of 5 mg of succinic acid (estimated to be approximately 31 mg per kg body weight per day) for 3 weeks.
- GLP compliance:
- no
Test material
- Reference substance name:
- Succinic acid
- EC Number:
- 203-740-4
- EC Name:
- Succinic acid
- Cas Number:
- 110-15-6
- Molecular formula:
- C4H6O4
- IUPAC Name:
- succinic acid
- Details on test material:
- Name: succinic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- other: sesame oil
- Details on exposure:
- Daily vaginal smears were made on 15 two-month-old female rats for a period of 2 weeks, after which 5 of the rats were ovariectomized. After a postoperative period of 7 days the 5 spayed rats ·were injected s.c. with 5.0 mg succinic acid (in sesame oi I) daily for 3 weeks. Daily vaginal smears were made and at the end of the injection period alI of the animals were sacrificed and microscopic sections were made of the uterine horn, cervix and vagina.
- Control animals:
- yes
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The daily vaginal smears showed no changes in the diestrus smear of the ovariectomized rats as compared to the controls and microscopic examination of the tissue sections revealed no significant changes.
Applicant's summary and conclusion
- Conclusions:
- Possible estrogenic properties of succinic acid were investigated in two month old ovariectomized rats. Daily subcutaneous injections of 5 mg of succinic acid (estimated to be approximately 31 mg per kg body weightper day) for 3 weeks did not change the typical diestrus vaginal smears compared to the controles and and microscopic examination of the tissue sections revealed no significant changes.
- Executive summary:
Using rats, Dye et al. conducted an experiment to test for possible estrogenic properties of succinic acid. Daily vaginal smears were made on 15 two-month-old female rats for a period of 2 weeks, after which 5 of the rats were ovariectomized. After a postoperative period of 7 days the 5 spayed rats were injected s.c. with 5.0 mg succinic acid (in sesame oil) daily for 3 weeks. Daily vaginal smears were made and at the end of the injection period alI of the animals were sacrificed and microscopic sections were made of the uterine horn, cervix and vagina. The daily vaginal smears showed no changes in the diestrus smear of the ovariectomized rats as compared to the controls and microscopic examination of the tissue sections revealed no significant changes.
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