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EC number: 241-972-8 | CAS number: 18063-03-1
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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: Non-GLP, near guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: commercial supplier (Porcellus Ltd., UK)
- Weight at study initiation: 623 g (males) and 571 g (females)
- Housing: hanging stainless-steel cages with all-mesh floors and tops and half-mesh fronts, each cage measured 54 cm x 31 cm x 36 cm
- Diet: SGl with vitamin C supplement, Grain Harvesters Ltd., Kent, ad libitum
- Water: ad libitum
- Acclimation period: at least two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Photoperiod (hrs dark / hrs light): 12 /12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Intradermal induction: corn oil; Epicutaneous induction and challange: petroleum jelly
- Concentration / amount:
- Induction:
Intradermal injection; 0.5% (m/v) in corn oil
Topical application; 50% (m/m) in petroleum jelly
Challenge:
Topical challange: 50% (m/m) in petroleum jelly - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Intradermal induction: corn oil; Epicutaneous induction and challange: petroleum jelly
- Concentration / amount:
- Induction:
Intradermal injection; 0.5% (m/v) in corn oil
Topical application; 50% (m/m) in petroleum jelly
Challenge:
Topical challange: 50% (m/m) in petroleum jelly - No. of animals per dose:
- Main test: ten males and ten females
Control group: five males and five females - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
The animals were closely shorn in the shoulder region using electric clippers followed by an electric razor; two rows of three injections were made, one on each side of the midline, as follows:
Test animals:
two injections (0.1 ml) of Freund's complete adjuvant (FCA)
two injections (0.1 ml) of the test material in solvent (corn oil)
two injections (0.1 ml) of the test material in 50:50 FCA/solvent (corn oil)
Control animals:
two injections (0.1 ml) of Freund's complete adjuvant (FCA)
two injections (0.1 ml) of solvent (corn oil)
two injections (0.1 ml) of 50:50 FCA/solvent (corn oil)
One week after induction by the intradermal injections, the same area of skin was shaved using electric clippers only. A 4 cm x 4 cm patch of Whatman Number 3 filter paper was coated with 0.45 ml of the test substance in petroleum jelly, placed over the site of injection and covered with a 'Sleek' dressing. The dressing was then securely covered with an 8 cm 'Poroplast' elastic adhesive bandage for 48 hours. Similar patches of filter paper (but moistened with the corn oil or petroleum jelly, as appropriate) were applied to the controls.
B. CHALLENGE EXPOSURE
Topical challenge was carried out two weeks after the topical induction. Hair was removed from a 3 cm x 3 cm area of one flank by clipping then shaving. A 2 cm x 2 cm patch of Whatman Number 3 filter paper moistened with 0.15 ml of the test substance in petroleum jelly was placed over the shaved area and covered with a 3 cm square of adhesive tape ('Blenderm') held in place by an 8 cm 'Poroplast' elastic adhesive bandage. Controls were also treated with the diluted test material. After 24 hours the patch was removed and the site examined for a response immediately, 24 and 48 hours after its removal. - Positive control substance(s):
- no
- Reading:
- other: immediate after challenge
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: immediate after challenge. . Hours after challenge: 0.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: 24 hours after challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 24 hours after challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: 48 hours after challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 48 hours after challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: immediate after challenge
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: immediate after challenge. . Hours after challenge: 0.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 24 hours after challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 24 hours after challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 48 hours after challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 48 hours after challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the test item has not to be classified as skin sensitizer.
- Executive summary:
The skin sensitisation potential of 2,6-difluorobenzamide was assessed in a maximisation test comparable to OECD guideline 406 (Sittingbourne Research Centre, 1987). In this study, guinea pigs (Dunkin-Hartley, 10/sex) were induced by intradermal injection (0.5% m/v in corn oil) and, one week later, by epicutaneous application (50% m/m in petroleum jelly). Two weeks after induction by epicutaneous application, the animals were challenged by epicutaneous application (50% m/m in petroleum jelly) for 24 hours. The response was scored immediately after removal of the patch and after 24 and 48 hours after patch removal. None of the animals showed positive reactions. The test material was therefore concluded not to be a skin sensitiser in guinea pigs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of 2,6-difluorobenzamide was assessed in a maximisation test comparable to OECD guideline 406 (Sittingbourne Research Centre, 1987). In this study, guinea pigs (Dunkin-Hartley, 10/sex) were induced by intradermal injection (0.5% m/v in corn oil) and, one week later, by epicutaneous application (50% m/m in petroleum jelly). Two weeks after induction by epicutaneous application, the animals were challenged by epicutaneous application (50% m/m in petroleum jelly) for 24 hours. The response was scored immediately after removal of the patch and after 24 and 48 hours after patch removal. None of the animals showed positive reactions. The test material was therefore concluded not to be a skin sensitiser in guinea pigs.
Migrated from Short description of key information:
No skin sensitisation potential was reported in guinea pigs upon intradermal (concentration: 0.5%) and epicutaneous (concentration: 50%) induction followed by epicutaneous challenge (concentration: 50%) with 2,6-difluorobenzamide in a guinea pig maximisation test.
Justification for selection of skin sensitisation endpoint:
Most reliable study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No 1272/2008, as amended for the fifth time in Directive EC 944/2013.
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