Registration Dossier

Diss Factsheets

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:
2001
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

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 crystalline melt
Details on test material:
Purity: 94.8% , Storage: darkness at approximately 20 °C in a fume cupboard.

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.