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EC number: 807-276-9 | CAS number: 1421695-64-8
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Although this test was performed after 2009, the study was conducted using the Buehler method to fulfill testing requirements for registration in another region.
Test material
- Details on test material:
- - Purity: 100%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Preliminary Irritation Group: Young Adult (5-8 weeks); Test and Naive Control Groups: Young adult (6 weeks)
- Weight at study initiation: 460-607 g
- Housing: animals were gang housed in stainless steel solid bottom cages
- Diet: Harlan Teklad Global Guinea Pig Diet® #2040. A designated amount of the diet was available to each guinea pig (approximately 20 grams/day).
- Water: Filtered tap water was supplied ad libitum.
- Acclimation period: 19-43 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23ºC
- Humidity (%): 44-82%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test substance
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test substance
- No. of animals per dose:
- Test Group: 20
Naive Control Group: 10 - Details on study design:
- RANGE FINDING TESTS:
A group of animals was used to determine the highest non-irritating concentration (HNIC) of the test substance prior to the challenge dose. The fur was removed from four guinea pigs by clipping the flanks of each guinea pig. This area was divided into four test sites (two sites on each side of the midline) on each animal. The test substance was applied neat (100%) and also diluted with acetone to yield w/w concentrations of 75%, 50% and 25%. Each concentration was applied (0.4 millilitre) onto an occlusive 25 mm Hill Top Chamber and applied to the appropriate test site. The sites were wrapped with non-allergenic Durapore™ adhesive tape. After six hours of exposure, the chambers were removed and the test sites were gently cleansed of any residual test substance. Approximately 24 and 48 hours after application, each site was evaluated for local reactions (erythema) according to the scoring system.
From these results, the HNIC (the highest concentration that produced responses in 4 guinea pigs no more severe than two scores of 0.5 and two scores of zero) was established and used for challenge. The HNIC selected for the challenge phase was 100%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Once each week for three weeks
- Exposure period: After the six hour exposure period, the chambers were removed and the test sites were gently cleansed of any residual test substance
- Test groups: 1 at 100% test substance
- Control group: 1
- Site: the left flank of each test animal
- Frequency of applications: Once each week for three weeks
- Duration: After the six hour exposure period, the chambers were removed and the test sites were gently cleansed of any residual test substance
- Concentrations: 100% test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: After the six hour exposure period, the chambers were removed and the test sites were gently cleansed of any residual test substance.
- Test groups: 1 at 100% test substance
- Control group: 1 "naive control" group
- Site: applied to the skin of a naive site on the right flank of each test animal
- Concentrations: 100% test substance
- Evaluation (hr after challenge): sites were evaluated for a sensitisation response (erythema) approximately 24 and 48 hours after the challenge application - Challenge controls:
- In addition to the test animals, 10 guinea pigs from the same shipment were maintained under identical environmental conditions and were treated with the test substance at challenge only. These animals constituted the "naive control" group.
- Positive control substance(s):
- yes
- Remarks:
- Historical positive control data with alpha-Hexylcinnamaldehyde (HCA)
Results and discussion
- Positive control results:
- Induction Phase
Historical Positive Control Animals (100% HCA): Very faint erythema (0.5) was noted for two positive control sites 24 hours after the second induction application. Very faint to faint erythema (0.5-1) was evident for all sites 24 and/or 48 hours after the third induction application.
Challenge Phase
Historical Positive Control Animals (100% test substance): Two of ten positive control animals exhibited signs of a sensitization response (faint erythema [1]) 24 hours after challenge with very faint erythema noted at all other sites. Very faint erythema (0.5) persisted at five sites through 48 hours.
Historical Positive Control Naïve Control Animals (100% HCA): There was no irritation noted at any positive control naïve control site during the challenge phase.
Historical Positive Control Rechallenge Phase
Historical Positive Control Animals (100% HCA): Three of ten positive control animals exhibited signs of a sensitization response (faint erythema [1]) 24 hours after challenge. Similar indications persisted at two of these sites through 48 hours. Very faint erythema (0.5) was noted for most other sites following challenge.
Historical Positive Control Naïve Control Animals (100% HCA): There was no irritation noted at any positive control naïve control site during the challenge phase.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: challenge and rechallenge phase
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: challenge and rechallenge phase
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: challenge phase
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: challenge phase
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: rechallenge phase
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: rechallenge phase
Any other information on results incl. tables
Induction Phase
Test Animals (100% test substance): There was no dermal irritation observed at any test site during the induction phase.
Challenge Phase
Test Animals (100% test substance): There was no dermal irritation noted at any test site 24 or 48 hours after the challenge application.
Naive Control Animals (100% test substance): There was no dermal irritation noted at any naive control site after the challenge application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not a skin sensitizer.
- Executive summary:
A dermal sensitisation test was conducted with guinea pigs to determine the potential for the test substance to produce sensitisation after repeated topical applications. Preliminary irritation testing was performed on 4 animals to determine appropriate concentrations of the test substance that could be used for both the induction and challenge phases. The HNIC selected for the challenge phase was 100%.
Twenty healthy test guinea pigs were selected for test and treated with the test substance during the induction and challenge phase. For the induction phase, the undiluted test substance was topically applied to the skin on the left flank of each of the 20 guinea pigs for six hours, once each week for a three-week induction period. Twenty-eight days after the first induction dose, a challenge dose of the test substance was applied to the skin of a naive site on the right flank of all test animals as described above. A naive control group (ten animals) was maintained under the same environmental conditions and treated with the test substance at challenge only. Approximately 24 and 48 hours after each induction and challenge dose, the test and naive control animals were scored for erythema.
Based on the results, none of the test animals (0 of 20) had a positive skin sensitisation response. Therefore, the test substance is not considered a skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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