Vanillic acid

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

Vanillic acid

EC Number:

204-466-8

EC Name:

Vanillic acid

Cas Number:

121-34-6

Molecular formula:

C8H8O4

IUPAC Name:

4-hydroxy-3-methoxybenzoic acid

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 or test system 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:

other: There were no systemic clinical signs noted in any animal throughout the study.

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.