Benzoic acid, 5-methyl-2-(2H-1,2,3-triazol-2-yl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

In Accordance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid

EC Number:

689-732-5

Cas Number:

956317-36-5

Molecular formula:

C10H9N3O2

IUPAC Name:

5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid

Details on test material:

Purity > 98 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, USA.
- Age at study initiation: Not specified.
- Weight at study initiation: Males, 265 - 270 g; females, 205 - 239 g.
- Fasting period before study: 16 - 20 hours.
- Housing: 3/sex/cage.
- Diet (e.g. ad libitum): PMI Rat Chow, ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified.
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12-hours light/dark.
IN-LIFE DATES: From: March 25, 2009 To: April 16, 2009

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% methyl cellulose

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 per sex/dose

Control animals:

no

Details on study design:

Three male and three female Wistar rats were dosed orally with the test item at 2000 mg/kg bw. The animals were observed for 0.5, 1, 2, 3 and 4 hours post-dose and then once daily for 14 days (males) or 19 days (females) for mortality, toxicity and pharmacological effects. Body weights were recorded at intervals to termination. All animals were examined for gross pathology on termination.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: Acute Tox Class

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities.

Clinical signs:

other: Rigid muscle tone, abnormal gait, ataxia and soiling / wetness of the anogenital area were observed on day 1.

Gross pathology:

All necropsy results were normal.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was greater than 2000 mg/kg bw in rats. Accordingly, the test item was considered to be in Acute Toxic Category 5 or unclassified.

Executive summary:

Three male and three female Wistar rats were dosed orally with the test item at 2000 mg/kg bw. The animals were observed for 0.5, 1, 2, 3 and 4 hours post-dose and then once daily for 14 days (males) or 19 days (females) for mortality, toxicity and pharmacological effects. Body weights were recorded at intervals to termination. Body weight changes were normal in 4/6 animals. One female lost weight between days 7 and 19. Another female lost weight between days 14 and 19. All animals were examined for gross pathology on termination. Necropsy results were normal.

The LD₅₀was greater than 2000 mg/kg bw in rats. Accordingly, the test item was considered to be in Acute Toxic Category 5 or unclassified.