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Diss Factsheets
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EC number: 608-681-1 | CAS number: 319-24-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP- and Guideline-Study with no or minor deficiencies.
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:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 96/54/EC Annex IV
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- methyl 2-amino-5-fluorobenzoate
- EC Number:
- 608-681-1
- Cas Number:
- 319-24-4
- Molecular formula:
- C8 H8 F N O2
- IUPAC Name:
- methyl 2-amino-5-fluorobenzoate
- Test material form:
- other: yellow liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH (Harlan)
- Sex:
- female
- Details on test animals and environmental conditions:
- 12 hours light/dark cycle
Humidity: 50±20 %
Food: Ssniff, ad libitum
Water: tap water in plastic bottles
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Positive control substance(s):
- yes
Results and discussion
Any other information on results incl. tables
DETERMINATION OF THE TOLERANCE OF THE INTRADERMAL INJECTIONS
Intradermal injections with the 5.0. 1.0 and the 0.2 % preparation caused clear edema and slight erythema. Based on this preliminary test, a 5.0 % preparation was selected for the intradermal injections in the main test.
DETERMINATION OF THE PRIMARY NON-IRRITATING CONCENTRATION
No signs of irritation occurred after administration of the different test concentrations.
Based on these results, a concentration of 100 % 2-Amino-5-fluorbenzoesaeuremethylester was chosen for the challenge at day 22.
MAIN TEST FOR THE SENSITIZING PROPERTIES
Body weight gains and clinical signs
The body weight gains of the animals were not impaired.
The treated animals showed no clinical signs of intoxication throughout the study.
Intradermal induction treatment
Intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and edema as well as indurations and encrustations. The administration sites treated with the test substance in sesame oil showed slight erythema and edema. Intradermal injections of the vehicle alone exhibited no signs of irritation.
Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at day 7.
Dermal induction treatment
After the removal of the patches at day 10, severe erythema and edema, indurated, scabbed and encrusted skin as well as necrosis were observed at the sites previously treated with Freund's Adjuvant. The administration sites treated with the test substance or the vehicle alone showed no signs of irritation.
Dermal challenge treatment
No skin reactions were observed in the control and the treatment group 24 and 48 hours after removal of the occlusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, none of the ten animals showed a positive skin response after the challenge procedure.
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