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EC number: 700-596-9 | CAS number: 14442-94-5
- 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
- Study period:
- 23 November to 15 December 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally recognised guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- T-1215A
- IUPAC Name:
- T-1215A
- Reference substance name:
- 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide
- EC Number:
- 700-596-9
- Cas Number:
- 14442-94-5
- Molecular formula:
- C35H63NO2
- IUPAC Name:
- 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide
- Reference substance name:
- 3-{3,5-Di-tert-butyl-4-hydroxyphenyl}-N-octadecyl-propionamide
- IUPAC Name:
- 3-{3,5-Di-tert-butyl-4-hydroxyphenyl}-N-octadecyl-propionamide
- Details on test material:
- - Name of test material (as cited in study report): T-1215A (3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-octadecyl-propionamide)
- Substance type: Solid
- Physical state: Powder
- Analytical purity: 97.1% (measured by GC)
- Impurities (identity and concentrations):
3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-hexadecyl-propionamide; 1.3%
3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-heptadecyl-propionamide; 1.6%
- Purity test date: 28 October 2004
- Lot/batch No.: 04HY1101
- Stability under test conditions:
- Storage condition of test material: Room temperature in the dark
- Other:
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: The animals were individually housed in suspended solid-floor polypropylene cages fumished with softwood woodflakes
- Diet: Certified Rat and Mouse Diet (Code 5LF2), ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): Approx 15
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light, 0600h to 1800h, and 12 hours dark.
IN-LIFE DATES: From: To:
Study design: in vivo (LLNA)
- Vehicle:
- other: Butanone
- Concentration:
- 5, 10 and 25 %w/w
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: None
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: The test matcrial will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporatlon will be classifled as a non-sensidser".
TREATMENT PREPARATION AND ADMINISTRATION: Following a preliminary screening test, three groups, each of five animals, were treated
with 50 µl (25 µl per ear) of the test material as a solution in butanone at concentrations of 5%, 10% or 25% w/w. A further group of five animals was treated with butanone alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- RESULTS
Preliminary Screening Test
No signs of systemic toxicity were noted. White residual test material was noted on the ears one hour post-dosing on Day 2 and for the remainder of the study. Fur loss was noted on Days 5 and 6. Based on this information the dose levels selected for the main test were 5%, l0% and 25% wlw in butanone.
Main Test
Estimation of the Proliferative Response of Lymph Node Cells
A stimulation index of less than 3 was recorded for the three concentrations of the test material(5%,10% and 25% w/w in butanone).
Clinical Observations and Mortality Data
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the study. White residual test material was noted on the ears of all test animals during the study.
Bodyweight
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Results and discussion
- Positive control results:
- At 5, 10 and 25 %v/v hexyl cinnamaldehyde was shown to be a sensitiser.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Substance / concentration (%w/w) Stimulation index Vehicle n/a 5 1.35 10 1.38 25 1.39
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Substance / concentration (%w/w) Mean dpm Vehicle 932.26 (±161.75) 5 1254.92 (±342.93) 10 1284.72 (±284.96) 25 1293.32 (±675.23
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
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