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EC number: 204-465-2 | CAS number: 121-33-5
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Even if all the detail are not given, the test condition described are reliable for the assessment. Test performed before GLP establishment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 955
- Report date:
- 1955
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- only male rats were used, exposure of 26 weeks instead of 13 weeks, no detailed information about the observations
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Vanillin
- EC Number:
- 204-465-2
- EC Name:
- Vanillin
- Cas Number:
- 121-33-5
- Molecular formula:
- C8H8O3
- IUPAC Name:
- 1-butoxypropan-2-ol
- Details on test material:
- Vanillin from Monsanto Chemical Company (USA), received on 18-JAN-1955
* Physical state: solid
* Analytical purity, impurities, purity test date, lot/batch No, expiration date of the lot/batch, stability under test conditions, storage condition of test material: data not available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Carworth Farms
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 57 to 74 g
- Housing: individually in wire meash cages elevated above the droppings
- Diet: ad libitum
- Water: ad libitum
- Source, age at study initiation, fasting period before study, acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- * DIET PREPARATION:
Rate of preparation of diet: weekly
Storage temperature of food: no data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 26 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 1 000 ppm
- Remarks:
- Nominal in diet. Corresponds to 0.1%.
- Dose / conc.:
- 5 000 ppm
- Remarks:
- Nominal in diet. Corresponds to 0.5%.
- Dose / conc.:
- 10 000 ppm
- Remarks:
- Nominal in diet. Corresponds to 1%.
- No. of animals per sex per dose:
- 10 animals per dose group
- Control animals:
- yes, plain diet
- Details on study design:
- Post-exposure period: none
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- * CAGE SIDE OBSERVATIONS: No data
* DETAILED CLINICAL OBSERVATIONS: No data
* BODY WEIGHT: Yes (weekly)
* FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
* FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
* OPHTHALMOSCOPIC EXAMINATION: No data
* HAEMATOLOGY: No data
* CLINICAL CHEMISTRY: No data
* URINALYSIS: No data
* NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- * SACRIFICE AND PATHOLOGY:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (see table) - Statistics:
- statistical analysis of body weight was by means of the Fisher Student "t" test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 ppm
- Sex:
- male
- Basis for effect level:
- other: no effect observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No effect related to vanillin was observed.
- Executive summary:
In a subchronic toxicity study (Anon., 1955) vanillin (purity unknown) was administered to male Carworth Farms rats, 10/dose, in diet at dose levels of 0, 1000, 5000, 10000 ppm.
No effect related to vanillin was observed.
The NOEL is 10000 ppm (equivalent to ca. 650 mg/kg bw/d).
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