Registration Dossier
Registration Dossier
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EC number: 609-664-1 | CAS number: 393-85-1
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:
- 1 994
- 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
- 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%
Constituent 1
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.
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