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Toxicological information

Toxicity to reproduction

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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:
1944
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:
1975
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:
1973
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

Constituent 1
Chemical structure
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

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.