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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive B.4. "Acute toxicity skin 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%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animal strain: Chbb: NZW (SPF), Origin: Chemisch pharmazeutische Fabrik Dr. K. Thomae 88400 Biberach, ID: numbered ear tags, BW: 2.4-3.1 kg, age of the animals: about 3-5 months, room temperature: 20+/3 °C, relative humidity: 50+/- 20% , light time period: 12 h light, 12 h dark diet: Altromin 2123 maintenance diet- rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g/day), drinking water: deionised chlorinated water from water dispensers, ad libitum. Storage: darkness at room temperature in the fume cupboard.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Amount / concentration applied:

0.5 ml 5-Fluoro-2-nitrobenzoic acid methyl ester

Duration of treatment / exposure:

4 hours of exposure. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Observation period:

Examination took place after 30-60 minutes , and 24 , 48 and 72 hours after removal of the patches.

Number of animals:

3 animals

Details on study design:

About 24 hours before the test start of the study the hair of the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2.Only animals with intact skin were used. The substance was applied over the whole surface of a 2.5 x2.5 cm cellulose patch on apiece of surgical plaster (specially produced by Beiersdorf AG, Hamburg). The plaster was fixed with a semi-occlusive bandage.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 days, 2days, 3 days

Score:

0

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study 5-Fluoro-2-nitrobenzoic acid methyl ester is not irritating to skin.