Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-280-9 | CAS number: 80-46-6
- 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:
- 11-09-2012 to 18-01-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study done to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- p-(1,1-dimethylpropyl)phenol
- EC Number:
- 201-280-9
- EC Name:
- p-(1,1-dimethylpropyl)phenol
- Cas Number:
- 80-46-6
- Molecular formula:
- C11H16O
- IUPAC Name:
- 4-(2-methylbutan-2-yl)phenol
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): phenol, 4-(1,1-dimethylpropyl)-
- Lot/batch No.: 20409018
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, Indianapolis, IN
- Age at study initiation: 7-12 weeks of age (adult)
- Weight at study initiation: 18.5-22.9 grams
- Housing: polycarbonate cages, group housed (5 per cage of same sex)
- Diet: Teklad 7012 Rodent Diet, Harlan Laboratories, Madison, WI, ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days, under same conditions as for the actual test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 ± 5 oF
- Humidity (%): 30-70%
- Air changes (per hr): a minimum of 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle, full spectrum fluorescent lights
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 100%, 50% and 25% w/v/ dosing solutions.
- No. of animals per dose:
- n =5
- Details on study design:
- - Compound solubility: Max soluble concentration 3.41 g/ml
A fresh dose solution was prepared on each day of dosing
TREATMENT PREPARATION AND ADMINISTRATION:
On Day 1, 25 microlitres of the test article or control article was applied to the dorsum of both ears.
The same procedure performed on Day 1 was repeated on Days 2 and 3.
There was no treatment on Days 4 and 5.
The animals were observed for clinical signs daily after dosing. Observations
conducted included all clinical and toxicological signs, including local irritation at the
application site or systemic toxicity. None of the animals died or exhibited adverse clinical
signs needing euthanasia prior to termination. No animals were replaced.
All animals were weighed at the end of the observation period.
On Day 6, 5 hours prior to sacrifice, all animals were injected intravenously with
250 microlitres of an 80 microCurie/mL solution of 3H-methyl thymidine in PBS (v/v). The concentration of
radio labeled tracer was verified before use.
The animals were sacrificed by carbon dioxide (C02) inhalation and the draining
auricular lymph nodes were excised from each animal.
A single cell suspension of the lymph node cells from each animal was prepared by
gentle mechanical desegregation.
The cell suspension was centrifuged, re-suspended in cold 5% TCA, allowed to
precipitate at 2 to 6 degrees C for 18 ± 1 hours. After precipitation, the cells were centrifuged and
re-suspended in fresh 5% TCA.
The level of radioactivity in the cells was measured using a scintillation counter. Each vial was counted three times.
- Criteria used to consider a positive response: The proliferative response of lymph node cells is expressed as the number of radioactive
disintegrations per minute per mouse (DPM/MOUSE) and as the Stimulation Index (SI). Sl is
obtained by comparing the proliferation of lymph node cells from test animals with the lymph
node cells from the control animals. That is, the ratio of radiolabeled thymidine incorporation in
the lymph node cells, expressed as a group mean DPM, relative to that for control lymph node
cells (TEST/CONTROL RATIO).
The test article is regarded as positive if the test article at the test concentration produces a
test/control ratio equal to or greater than 3.0 and is statistically significant relative to the
negative control. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Appropriate statistical methods are performed to aid in the interpretation of radioactivity
results. Groups differing from the negative control at the level of p < 0.05 are considered
statistically significant.
Results and discussion
- Positive control results:
The Stimulation Index of the positive control animals when compared to the negative control animals was 10.05 (p < 0.0001).
Hexylcinnamaldehyde was clearly positive in the assay.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks on result:
- other: The Stimulation Index of the test animals treated with the 100%, 50%, and 25% concentrations of the test article when compared to the negative control animals were: 8.19 (p = 0.0113), 9.66 (p = 0.0010), and 6.91 (p < 0.0001).
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Data provided in tabular form below
Any other information on results incl. tables
Disintegrations per minute (DPM) for each of the test substances (n=5 animals per group), with mean and SD
DMSO | Hexylcinnamaldehyde | 25% PTAP | 50% PTAP | 100% PTAP | |
675.99 | 4584.96 | 3344.62 | 2280.50 | 1265.70 | |
551.36 | 4081.94 | 2770.56 | 3232.55 | 2525.20 | |
613.92 | 5164.41 | 3581.27 | 6357.37 | 5007.96 | |
410.02 | 5245.38 | 4408.53 | 5715.82 | 7601.05 | |
227.85 | 5843.58 | 3027.46 | 6360.64 | 3905.08 | |
Mean | 495.83 | 4984.05 | 3426.49 | 4789.38 | 4061.00 |
SD | 179.35 | 673.18 | 629.39 | 1904.20 | 2430.30 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- At all test concentrations (25%, 50% and 100% w/v PTAP in DMSO), the stimulation index was greater than 3-fold higher than the negative control.
P-tert amylphenol was sensitising at all concentrations tested, and can be regarded as a 'moderate' sensitiser. - Executive summary:
In an OECD guideline 429 Murine Local Lymph Node Assay (LLNA), the test substance p-tert amyl phenol was dissolved in dimethyl sulphoxide (DMSO) at concentrations of 25%, 50% and 100% w/v, and was found to be sensitising (SI > 3-fold above vehicle control) at all concentrations tested. P-tert amyl phenol is a sensitiser under the conditions of this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.