Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10/03/02 - 11/04/02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No certificate of analysis, normally a single sex (females) is tested, 500 mg/kg bw should not have been tested (2 assays with 2000 mg/kg bw would have been better).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Simplified study.
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Vanillic acid
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature
- Stability under test conditions: yes

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Indianapolis, IN.
- Age at study initiation: 5 - 6 weeks old.
- Weight at study initiation: 200.8 to 335.7 g. Weighed to nearest 0.1 g. The weight variation of animals used in the test did not exceed +/- 20% of the mean weight for each sex.
- Fasting period before study: yes
- Housing: 3 animals / cage (Type II. polypropylene/polycarbonate).
- Food consumption (e.g. ad libitum): ad libitum
- Water consumption (e.g. ad libitum): ad libitum
- Acclimation period: Minimum 5 days under the same conditions as for the actual test.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 5 °C
- Humidity (%): 30 – 70 %
- Air changes (per hr): 10 to 15 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12hr/12hr




Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
No data available.
Doses:
500 mg/kg bw (males) and 2000 mg/kg bw (females).
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
DETAILS ON STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations: animals were examined for signs of reaction to treatment on dosing, at intervals during the day of dosing, then daily for a total of 14 days.
- Frequency of weighing: all animals were weighed on allocation to study and on the day of dosing (Day 0). Surviving animals were weighed at weekly intervals (Days 7 and 14). Animals dying during the study were weighed at the time of death or when found.
- Necropsy of survivors performed: yes on day 15
- Other examinations performed: macroscopic examination at necropsy including the openingof the cranial, thoracic and abdominal cavities and the examination of the major organs. The stomach and representative sections of the gastro-intestinal tract were opened for examination.
Statistics:
no data

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Vanillic acid did not cause mortality (0/3 at 500 mg/kg bw and 0/3 at 2000 mg/kg bw).
Clinical signs:
There were no systemic clinical signs noted in any animal throughout the study.
Body weight:
There were no treatment related body weight changes.
Gross pathology:
There was no evidence of the macroscopic observations at necropsy at a dose level of 2000 mg/kg bw.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral LD50 value of the test item Vanillic acid was found to be above 2000 mg/kg bw in rats. Therefore, no classification is required according to EU criteria.
Executive summary:

In an acute oral toxicity study (Comparable to OECD 423, Reliablity 2, GLP), Vanillic acid was evaluated for its potential to produce death following oral administration at a dose of 500 mg/kg bw in male and at a dose of 2000 mg/kg bw in female rats.

Vanillic acid did not cause mortality in both tested doses. There were no systemic clinical signs noted in any animal throughout the study. There were no treatment related body weight changes. There was no evidence of the macroscopic observations at necropsy at a dose level of 2000 mg/kg bw.

Under the conditions of this study, the acute oral LD50 value of Vanillic acid was found to be above 2000 mg/kg bw in rats. As no mortality and no clinical signs were observed at 2000 mg/kg bw, no classification is required according to EU criteria.