Benzoic acid, 4-(acetylamino)-5-iodo-2-methoxy-, methyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Protocol approval date: 18 January 2001 - Report approval date: 10 May 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study report did not contain a reference to an international guideline. Further, the study was performed according to SOP in a laboratory that conforms to GLP, but the report was not audited by the QAU.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

This type of study is no longer part of the OECD guidelines for the Testing of Chemicals

Principles of method if other than guideline:

A single-dose oral toxicity study (limit study) was performed by gavage in 20 rats, including a treatment group of 10 rats exposed to the test material and a control group of 10 rats treated with the vehicle. The dosing was followed by an observation period of 15 days.

GLP compliance:

no

Remarks:

Study performed according to SOP in a laboratory that conforms to GLP, but report not audited by the QAU

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

IODOMESAC

IUPAC Name:

IODOMESAC

Constituent 2

Reference substance name:

Methyl 4-(acetylamino)-5-iodo-2-methoxybenzoate

IUPAC Name:

Methyl 4-(acetylamino)-5-iodo-2-methoxybenzoate

Constituent 3

Reference substance name:

methyl 4-acetamido-5-iodo-2-methoxybenzoate

EC Number:

606-440-5

Cas Number:

201214-53-1

Molecular formula:

C11H12INO4

IUPAC Name:

methyl 4-acetamido-5-iodo-2-methoxybenzoate

Test material form:

solid - liquid: suspension

Details on test material:

- Name of test material (as cited in study report): Iodomesac
- Physical state: solid, powder
- Impurities (identity and concentrations): no data available
- Lot/batch No.: 204386
- Expiration date of the lot/batch: 15/05/2001
- A certificate of analysis is included in the report.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Crédo, Domaine des Oncins, 69210 L’Arbresle, France
- Age at initiation of treatment: 5 weeks
- Weight at initiation of treatment: Male: 114 to 126 g; Female: 113 to 124 g
- Fasting period before study: Food was withdrawn 18 hours before treatment and redistributed approximately 4 hours after gavage
- Housing: housed in wire mesh bottomed, stainless steel cages. Space allocated: 891cm² x 18 cm (2 or 3 rats per cage).
- Diet (e.g. ad libitum): controlled pelleted rodent diet (re. AO4C.10, U.A.R.) ad libitum
- Water (e.g. ad libitum): free access to controlled tap water through automatic waterers
- Acclimation period: 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/– 2 ° C
- Humidity: 40-70%
- Air flow: 10-12 changes/hour without recirculation
- Photoperiod: 12/24 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.6% methylcellulose aqueous solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Suspension in a 0.6% methylcellulose aqueous solution
- Administration volume: 10 mL/kg

Doses:

0 and 2000 mg/kg

No. of animals per sex per dose:

5 rats/sex/dose

Control animals:

yes

Details on study design:

- Treatment frequency: Once, a single administration on day 1 (D1)
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
= Clinical signs: daily observations
= Body weight (D1, 3, 8, 15)
- Necropsy of survivors performed: yes at D15

Statistics:

no data

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

other: suspended

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

other: suspended

Mortality:

No mortality observed at any dose

Clinical signs:

other: No treatment-related changes.

Gross pathology:

No treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The maximal non-lethal dose determined experimentally was 2000 mg/kg in male and female rats (with LD50 > 2000 mg/kg). This dose did not induce any adverse effects.