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EC number: 800-884-5 | CAS number: 1154308-86-7
- 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 (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:
- 2 012
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide
- EC Number:
- 800-884-5
- Cas Number:
- 1154308-86-7
- Molecular formula:
- C11 H23 N1 O2
- IUPAC Name:
- N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide
- Test material form:
- other: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK, Margate
- Age at study initiation: 8 to 11 weeks
- Weight at study initiation: 18.4 to 22.5 g
- Housing: Two per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21°C
- Humidity (%): 48% to 65%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: To: 01 August to 13 August 2012
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0%, 25%, 50% and 100%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Pre-study formulation trial
- Irritation: No irritation in preliminary phase animals
- Lymph node proliferation response: Maximum SI = 2.2
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: SI greater than or equal to 3 in any group
TREATMENT PREPARATION AND ADMINISTRATION: Once daily for 3 consecutive days: 25 microlitres per ear per mouse of control or test formulation - Statistics:
- Dixon's Q-test for detection of a single outlier applied to the individual disintegrations per minute values
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1
- Test group / Remarks:
- control
- Remarks on result:
- other: Mean DPM at 0% = 1646
- Key result
- Parameter:
- SI
- Value:
- ca. 1.9
- Test group / Remarks:
- dose 25%
- Remarks on result:
- other: Mean DPM at 25% = 3062
- Key result
- Parameter:
- SI
- Value:
- ca. 2.2
- Test group / Remarks:
- dose 50%
- Remarks on result:
- other: Mean DPM at 50% = 3573
- Key result
- Parameter:
- SI
- Value:
- ca. 2.2
- Test group / Remarks:
- dose 100%
- Remarks on result:
- other: Mean DPM at 100% = 3640
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the conditions of the study, since treatment with the substance at concentrations of up to 100% (ie undiluted substance) did not achieve a stimulation index of greater than or equal to 3, it was considered that the test item does not have the potential to cause skin sensitisation.
- Executive summary:
A study was conducted to determine the sensitising potential of test substance in a mouse local lymph node assay conducted according to OECD Guideline 429, in compliance with GLP. The objective of this study was to determine the delayed contact hypersensitivity potential of the test substance. The study was performed using female CBA/Ca mice. A pre‑study formulation trial showed that acetone:olive oil, 4:1 v/v (AOO) was the most suitable vehicle for the substance and that a concentration of 50% was achievable. In the preliminary test an open application of 25 µL of undiluted test substance was administered onto the dorsum of each ear of 2 animals. As a result of the findings from the preliminary test, four animals per dose were exposed to the test substance at 25, 50 and 100% concentrations in the main study. The animals received 25 µL of the appropriate formulation onto the dorsum of each ear on 3 consecutive days. There were no systemic signs and no signs of local irritation in any animal during the observation period. Clinical signs were restricted to wetness to the head in animals treated with the substance. This was considered to be merely an accumulation of test substance residues. Body weight losses were recorded in all groups, including controls, and were not considered to be treatment-related. Three days after the final application each animal received an intravenous injection of [methyl-3H] thymidine into the lateral tail vein. Approximately 5 h later the draining lymph nodes were collected in order that incorporation of tritiated thymidine could be assessed by scintillation counting. The stimulation indices (SI) for the three test groups, when compared with the vehicle, were 1.9, 2.2 and 2.2, respectively. Under the conditions of the study, since treatment with the substance at concentrations of up to 100% (i.e., undiluted substance) did not achieve a stimulation index of greater than or equal to 3, it was considered that the test substance does not have the potential to cause skin sensitisation (Robertson, 2012).
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