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EC number: 814-217-0 | CAS number: 353258-35-2
- 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)
- Remarks:
- Magnusson and Kligman method
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nousan-8147 (2000)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: Magnusson and Kligman (M&K) Method
Test material
- Reference substance name:
- 8-chloro-6-(trifluoromethyl)imidazo[1,2-a]pyridine-2-carboxylic acid
- Cas Number:
- 353258-35-2
- Molecular formula:
- C9H4ClF3N2O2
- IUPAC Name:
- 8-chloro-6-(trifluoromethyl)imidazo[1,2-a]pyridine-2-carboxylic acid
1
- Specific details on test material used for the study:
- Test substance: IN-QEK31-011
Lot number: SG0312574
Purity: 98.2%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 1% w/w
- Day(s)/duration:
- on Day 01
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- other: Topical
- Vehicle:
- propylene glycol
- Concentration / amount:
- 45% w/w
- Day(s)/duration:
- on Day 07 (48 hour application)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- The HNIC (the highest concentration that produced responses in four guinea pigs no more severe than two scores of 0.5 and two scores of zero) selected for the challenge phase was a 60% w/w mixture in propylene glycol. A quantity equal to 0.5 mL of propylene glycol was applied to one chamber and positioned on the right middle flank. The remaining two chambers containing 0.5 grams of a 60% w/w mixture of the test substance in propylene glycol (HNIC) and 0.5 mL of a 20% w/w mixture in propylene glycol (33% dilution of the HNIC) were positioned on the left front and rear flank, respectively.
- Day(s)/duration:
- on Day 20 (24 hour application)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary Irritation Testing: 12 (4/group)
Test Group: 20
Test Vehicle Control Group: 10 - Positive control substance(s):
- no
- Remarks:
- alpha-Hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 and 60% w/w mixture in propylene glycol and 100% vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 and 60% w/w mixture in propylene glycol and 100% vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 and 60% w/w mixture in propylene glycol and 100% vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 and 60% w/w mixture in propylene glycol and 100% vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not considered to be a contact skin sensitizer.
- Executive summary:
A Magnusson-Kligman test was conducted with guinea pigs to determine the potential for test substance to invoke dermal skin sensitization reactions according to guidelines OECD 406, US EPA OPPTS 870.2600, EC B.6, JMAFF. The study was conducted using four stages; preliminary irritation screens, a two-stage induction phase, and a challenge phase as described below.
Preliminary irritation testing was performed on twelve animals to determine appropriate concentrations of the test substance that could be used for both intradermal and topical induction as well as topical challenge.
An emulsion of 50% v/v Freund’s Adjuvant Complete in distilled water was used during the intradermal injection screening and the injection induction phases. This emulsion was thoroughly mixed using a stir plate and is referred to throughout the report as an emulsion of Freund’s Adjuvant Complete.
The first induction phase involved six intradermal injections into the suprascapular area of each of 20 guinea pigs. These doses were comprised of pairs of injections of the test substance in propylene glycol (1% w/w), the test substance (1% w/w) combined with an emulsion of Freund’s Adjuvant Complete, as well as an emulsion of Freund’s Adjuvant Complete alone. A sham control group (ten animals) was maintained under the same environmental conditions and received injections of propylene glycol (100%), propylene glycol (50% w/w) combined with an emulsion of Freund’s Adjuvant Complete, as well as an emulsion of Freund’s Adjuvant Complete alone. Approximately 24 and 48 hours after the injections, all sites were evaluated for an irritation response (erythema).
Approximately one week later, the second phase of induction was conducted. The test substance as a 45% w/w mix in propylene glycol (test group) or propylene glycol (test vehicle control group) was applied topically for a period of 48 hours to the area encompassing the intradermal injection sites. Approximately one hour after the topical induction patches were removed, all animals were scored for erythema. Approximately two weeks later, a primary challenge consisting of three occluded applications was conducted on each animal. One Hill Top Chamber containing 0.5 mL of propylene glycol was applied to a naive site on the right middle flank of each animal. The remaining two Hill Top Chambers containing 0.5 grams of the HNIC (Highest Non-Irritating Concentration, determined in the preliminary irritation screen to be an 60% w/w mixture in propylene glycol) of the test substance and 0.5 mL of a 33% dilution of the HNIC (20% w/w mixture in propylene glycol) were positioned on two naive sites on the left front and rear flank, respectively, for approximately 24 hours. The test vehicle control group was also treated with the test substance and test vehicle (as described above) at challenge. Approximately 24 and 48 hours after challenge patch removal, all animals were scored for a sensitization response (erythema).
Based on the results of this study, test substance is not considered to be a contact skin sensitizer. The positive response observed in the historical positive control validation study with alpha-Hexylcinnamaldehyde, ≥ 95% (HCA) validates the test system used in this study.
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