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EC number: 203-740-4 | CAS number: 110-15-6
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- sub-chronic toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- before 1944
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Old study with methodological deficiencies.
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:
- Albino rats, seven days old, were injected subcutaneously with 0. 5 mg of succinic acid in sesame oil, and daily thereafter with increasing doses until they were receiving 2. 0 mg per day at four weeks of age (estimated to be approximately 20 mg succinic acid per kg body weight per day); this dosage was continued until the rats were 60 days old. Control animals received similar doses of sesame oil only. All the rats were weighed and measured weekly. and the times of hair appearance, tooth eruption, eye opening, and vaginal opening were recorded.
- 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:
- other: "albino"
- Sex:
- not specified
- 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:
- Albino rats, seven days old, were injected subcutaneously with 0. 5 mg of succinic acid in sesame oil, and daily thereafter with increasing doses
until they were receiving 2. 0 mg per day at four weeks of age (estimated to be approximately 20 mg succinic acid per kg body weight per day); this
dosage was continued until the rats were 60 days old. Control animals received similar doses of sesame oil only. All the rats were weighed
and measured weekly and the times of hair appearance, tooth eruption, eye opening, and vaginal opening were recorded. - Analytical verification of doses or concentrations:
- not specified
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Albino rats, seven days old, were injected subcutaneously with 0. 5 mg of succinic acid in sesame oil, and daily thereafter with increasing doses until they were receiving 2. 0 mg per day at four weeks of age (estimated to be approximately 20 mg succinic acid per kg body weight per day); this dosage was continued until the rats were 60 days old. Control animals received similar doses of sesame oil only. All the rats were weighed and measured weekly and the times of hair appearance, tooth eruption, eye opening, and vaginal opening were recorded.
Examinations
- Observations and examinations performed and frequency:
- All the rats were weighed and measured weekly and the times of hair appearance, tooth eruption, eye opening, and vaginal opening were recorded.
Results and discussion
Results of examinations
- Details on results:
- There were no significant differences between the treated and the control animals except for a possible tendency toward delayed opening of the vagina in the test rats (57. 2 days) compared with the controls (49. 4 days).
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no significant differences between the treated and the control animals except for a possible tendency toward delayed opening of the vagina in the test rats (57. 2 days) compared with the controls (49. 4 days).
- Executive summary:
15 rats were injected s.c. at 7 days of age with a dosage of 0.5 mg of succinic acid (in sesame oil) and daily thereafter with increasing doses until they were receiving 2.0 mg per day at tour weeks of age. This level of dosage was continued until the rats reached 60 days of age. As controls, 90 rats received similar doses of sesame oil only. The rats were weighed and measured weekly and the time of hair appearance, tooth eruption, eye opening, and vaginal opening were recorded for each rat. No significant differences between the treated and the control rats were observed, except possibly in the opening of the vagina. The average age of opening in the test rats was 57.2 days as compared to 49.4 for the controls.
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