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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
Endpoint summary
Administrative data
Description of key information
An OECD guideline 429 Murine Local Lymph
Node Assay (LLNA)
An OECD guideline 406 Buehler test
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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)
- 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 - 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. - 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.- 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Two studies, an LLNA and a Buehler test both indicate that p-tert amyl phenol is a sensitiser.
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.
In a dermal sensitization study according to OECD guideline 406, p-tert-amylphenol (> 99.5 %) in vaseline was tested in female guinea pigs (strain Dunkin-Hartley)(20 test animals and 10 control animals for the main experiment; 6 animals for the pre-test) using the method of Buehler. Based on the result of a pre-test the induction concentration used was 50 %. The induction phase led to severe skin reactions from the second phase on. However, individual application of 10% during the pre-tests and 50% during the induction phase did not show significant skin reaction after 30h - while 10% application on intact skin during the challenge phase resulted in clear skin reaction (erythema, pustules).
Justification for selection of skin sensitisation endpoint:
OECD guideline 429 study performed to GLP
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based upon the results of both the LLNA study and the Buehler test on p-tert amyl phenol, this material should be classified as a skin sensitiser
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