Registration Dossier
Registration Dossier
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EC number: 609-664-1 | CAS number: 393-85-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: U.S.EPA: OPPTS 870.2600, Health Effects Test Guidelines
- Qualifier:
- according to guideline
- Guideline:
- other: Commision Directive 96/54/EC Annex IV C Method B.6. Skin sensitisation
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
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 crystalline melt
- Details on test material:
- Purity: 94.8% , Storage: darkness at approximately 20 °C in a fume cupboard.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc: DH (Harlan)
- Details on test animals and environmental conditions:
- ID: fur marking with KMnO4 and cage numbering, makrolon cages (type V) on soft wood granulate in an air conditioned room, Room temperature: 20+/- 3°C, Relative humidity: 50+/- 20 %, Lighting times: 12 hours light, acclimatization: at least five days, food: sniff Ms-H (2233) ad libitum, water: Tap water in plastic bottles
Study design: in vivo (non-LLNA)
Induction
- Vehicle:
- other: sesame oil
Challenge
- Vehicle:
- other: sesame oil
- No. of animals per dose:
- In treatment group: 10 animals
Results and discussion
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the following test conditions of the present study in total seven of ten animals of the treatment group showed a positive skin response after the procedure. Based on the results 5 -Fluoro-2 -nitrobenzoic acid methyl ester may cause sensitization by skin contact according to the classification criteria of Directive 93/21/EEC.
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