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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

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 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive B.5. 'Acute toxicity eye irritation' of Directive 84/449/EEC

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

5-Fluoro-2-nitrobenzoic acid methyl ester

EC Number:

609-664-1

Cas Number:

393-85-1

Molecular formula:

C8H6FNO4

IUPAC Name:

5-Fluoro-2-nitrobenzoic acid methyl ester

Test material form:

other: yellow liquid

Details on test material:

purity: 96.9+/- 0.2 %, storage: Darkness at room temperature under the fume cupboard

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Weight of the animals: 3.0-3.4 kg, age of the animals: about 3-5 months, animal housing: In fully air-conditioned rooms, seperate cages (arranged in a battery), room temperature: 20+/-3 °C, relative humidity: 50+/- 20 %, lighting time: 12 hours per day, diet: Altromin 2123 maintencance-rabbits (Altromin GmBH, Lage/Lippe ), ad libitum and hay (approx. 15 g per day), strain: chbb:NZW (SPF), source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 88400 Biberbach , ID: numbered ear tags

Test system

Controls:

other: The untreated eye served in each case as a control

Amount / concentration applied:

0.1 ml per eye

Duration of treatment / exposure:

Administered once

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 animals

Details on study design:

About 24 hours before the start of the experiment the eyes of all animals were examined under UV-light for corneal lesions after instillation of one drop of a 0.01 % fluorecein-sodium solution. Only animals without occular abnormalities were used for this study.0.1 ml of the testing substance was applied once to the conjunctival sac of the left eye of 3 rabbits. The untreated eye served in each case as a control. The eyes were examined 1,24,48 adn 72 hours after application of the testing substance. At 24 h and 72 h the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% of fluorescein-sodium solution.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24h;48;72h

Score:

0.1

Max. score:

0.3

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The testing of 5-Fluoro-2-nitrobenzoic acid methyl ester for primary eye irritation in the rabbit showed that the substance is not irritating to the eye.