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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Antinociceptive, hypoglycemic and spasmolytic effects of Brickellia veronicifolia
Author:
Francisco Palacios-Espinosa, Myrna De´ ciga-Campos, Rachel Mataa
Year:
2008
Bibliographic source:
Journal of Ethnopharmacology 118 (2008) 448–454

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Antinociceptive activity of 2-methoxybenzoic acid in mice was studied using Hot-plate test
GLP compliance:
not specified
Test type:
other: No data available
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
o-anisic acid
EC Number:
209-447-8
EC Name:
o-anisic acid
Cas Number:
579-75-9
Molecular formula:
C8H8O3
IUPAC Name:
2-methoxybenzoic acid
Test material form:
solid: crystalline
Details on test material:
- Name of test material : 2-methoxybenzoic acid (2-MBA)
- Molecular formula : C8H8O3
- Molecular weight :152.1482 g/mole
- Smiles notation: COc1ccccc1C(=O)O
- InChl:1S/C8H8O3/c1-11-7-5-3-2-4-6(7)8(9)10/h2-5H,1H3,(H,9,10)
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material : 2-methoxybenzoic acid (2-MBA)
- Molecular formula : C8H8O3
- Molecular weight :152.1482 g/mole
- Smiles notation: COc1ccccc1C(=O)O
- InChl:1S/C8H8O3/c1-11-7-5-3-2-4-6(7)8(9)10/h2-5H,1H3,(H,9,10)
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
mouse
Strain:
ICR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Centro UNAM-Harlan (Harlan Mexico, S.A. de C.V.).
- Age at study initiation: No data available
- Weight at study initiation: 20–25 g
- Fasting period before study: Yes, twelve hours before the experiments food was withheld, but animals had free access to drinking water.
- Housing: Animals were housed under standard laboratory conditions as per Mexican Official Norm for Animal Care and Handing (NOM-062-ZOO-1999) and in compliance with international rules on care and use of laboratory animals.
- Diet (e.g. ad libitum): Standard pellet diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: saline solution with Tween® 80 (0.05%).
Details on oral exposure:
Details on exposure
VEHICLE
- Concentration in vehicle: 0, 1, 10, 31.6 and 100 mg/kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): 2-methoxybenzoic acid was suspended with Tween® 80 (0.05%) in saline solution (SS) and then administered orally.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available
Doses:
0, 1, 10, 31.6 and 100 mg/kg bw
No. of animals per sex per dose:
Total: 30
0 mg/kg: 6 mice
1 mg/kg: 6 mice
10 mg/kg: 6 mice
31.6 mg/kg: 6 mice
100 mg/kg: 6 mice
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days (or other?): No detailed data available
- Frequency of observations and weighing: Animals were observed before and 30, 60, 90, 120 and 150 min after treatments.
- Necropsy of survivors performed: No data available
- Other examinations performed: other: Antinociceptive activity were observed by using Hot-plate test.

Statistics:
Data are expressed as the mean ±S.E.M. for the number (n=6) of animals in each group. In all cases the results of treated-animal (compounds, extracts and reference drugs) groups were compared with the appropriate control (vehicle) groups. Statistical analysis was performed with one-way ANOVA followed by Dunnett post hoc to determine the source of significant differences where appropriate; *P < 0.05 was considered statistically significant. Prisma Graph-Pad (version 4.0) software was used for statistics and plotting. Analysis of variance was also performed.

Results and discussion

Preliminary study:
No data avaialble
Effect levels
Sex:
male
Dose descriptor:
other: TDLo
Effect level:
10 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Significant increase in noxius stimulation
Mortality:
No data available
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
Antinociceptive activity:
A significant dose dependent increase was observed in pain response of treated mice when test by using hot plate test as compare to control.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
TDLo was considered to be 10 mg/kg when male ICR (Mus domesticus) mice were treated with 2-methoxybenzoic acid (2-MBA) orally.
Executive summary:

Acute oral toxicity study was conducted to evaluate the antinociceptive effect of the test compound 2-methoxybenzoic acid (2-MBA) in Male ICR (Mus domesticus) mice in the concentration of 0, 1, 10, 31.6 and 100 mg/kg. Results show dose dependent increase in pain response of treated mice as compared to control. Therefore, TDLo was considered to be 10 mg/kg when male ICR (Mus domesticus) mice were exposed to 2-methoxybenzoic acid (2-MBA) orally.