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Toxicological information

Repeated dose toxicity: oral

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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:
1955
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

Constituent 1
Chemical structure
Reference substance name:
Vanillin
EC Number:
204-465-2
EC Name:
Vanillin
Cas Number:
121-33-5
Molecular formula:
C8H8O3
IUPAC Name:
4-hydroxy-3-methoxybenzaldehyde
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

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 / concentrations
Remarks:
Doses / Concentrations:
1000, 5000, and 10000 ppm (or 0.1%, 0.5%, and 1.0%)
Basis:
nominal in diet
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

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).