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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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

Constituent 1
Chemical structure
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.