Benzoic acid, 2-amino-5-fluoro-, methyl ester

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:

other: GLP- and Guideline-Study with no or minor deficiencies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EG-Guideline B.1. Acute Toxicity of the Directive 92/69/EWG

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

methyl 2-amino-5-fluorobenzoate

EC Number:

608-681-1

Cas Number:

319-24-4

Molecular formula:

C8 H8 F N O2

IUPAC Name:

methyl 2-amino-5-fluorobenzoate

Test material form:

other: light yellow mass

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Body weight at start of study: Male 175 +/- 3 g; Female 202 +/- 1 g
Age: Male approx. 7 weeks, Female approx. 8 weeks
relative humidity 50± 20 %
lighting time 12 hours
room temperature 22± 3 °C
water: tap water in plastic bottles ad libitum
food: Altromin 1324 rat diet ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

20 % solution in sesam oil. The application the volume being 20 ml/kg bw

Doses:

2000 mg/kg bw

Details on study design:

The observation p. a. lasted for 14 days. At the end of the study the rats were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Results and discussion

Preliminary study:

In a dose range finding study the doses 500, 1000 and 2000 mg/kg of the test item were tested at each one Male and one female animal. No mortallity has been obeserved. The animals of the 2000 mg/kg bw-group showed unspecific symptoms as well as impairments of motility. The body weight development was not impaired. The animals killed at the end of the study showed no macroscopically visible changes.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: stilted, uncoordinated and ataxic gait, decreased spontaneous activity, sunken flanks, and prone position, 2 days after application the symptoms were reversible.

Gross pathology:

no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality occurred during the study. The highest dose used in the study was 2000 mg/kg bw.