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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.