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EC number: 447-830-3 | CAS number: -
- 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:
- 24 March 2004 to 05 April 2004.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- -
- EC Number:
- 447-830-3
- EC Name:
- -
- Molecular formula:
- Not applicable to this UVCB substance.
- IUPAC Name:
- 2-ethylphenol; 3,5-dimethylphenol; formaldehyde; phenol
- Test material form:
- other: solid resin
- Details on test material:
- Date received: 30 January 2004
Storage conditions: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: B & K Universal Ltd, Hull, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet (e.g. ad libitum): free access to certified rat and mouse feed
- Water (e.g. ad libitum): free access to mains tap water
- Acclimation period: at least 5 days
- Other: The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06.00 to 18.00) and twelve hours darkness
IN-LIFE DATES: From: 24 March 2004 To: 05 April 2004
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5%, 10% or 25% w/w in acetone/olive oil 4:1.
- No. of animals per dose:
- 4 females per dose
- Details on study design:
- RANGE FINDING TESTS:
As no toxicological information was available regarding the systemic toxicity/irritancy potential of the test material a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 μL of the test material at a concentration of 25 % w/w in acetone/olive oil 4:1, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Any signs of toxicity or excessive local irritation noted during this period were recorded. The bodyweight of the mouse was recorded on Day 1 (prior to dosing) and on Day 6.
MAIN STUDY
TEST MATERIAL ADMINISTRATION
Groups of four mice were treated with the test material at concentrations of 5 %, 10 % or 25 % w/w in acetone/olive oil 4:1. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 μL of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
³H-METHYL THYMIDINE ADMISISTRATION
Five days following the first topical application of the test material (Day 6) all mice were injected via the tail vein with 250 μL of phosphate buffered saline containing ³H-methyl thymidine (³HTdR: 80 μCi/mL, specific activity 2.0 Ci/mmol, Amersham Biosciences UK Ltd) giving a total of 20 μCi to each mouse.
OBSERVATIONS
Clinical Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the study were recorded.
Bodyweights: The bodyweight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).
TERMINAL PROCEDURES
Termination: Five hours following the administration of ³HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experimental group. For each group, 1 ml of phosphate buffered saline (PBS) was added to the pooled lymph nodes.
Preparation of Single Cell Suspension: A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through a 200-mesh stainless steel gauze. The lymph node cells were rinsed through the gauze with 4 mL of PBS into a petri dish labelled with the project number and dose concentration. The lymph node cell suspension was transferred to a 10 mL centrifuge tube. The petri dish was washed with an additional 5 mL of PBS to remove all remaining lymph node cells and these were added to the centrifuge tube. The pooled lymph node cells were pelleted at 1400 rpm (approximately 190 g) for ten minutes. The pellet was resuspended in 10 ml of PBS and re-pelleted. To precipitate out the radioactive material, the pellet was resuspended in 3 mL of 5 % Trichloroacetic acid (TCA).
Determination of ³HTdR Incorporation: After overnight incubation at 4 °C, the precipitates were recovered by centrifugation at 2100 rpm (approximately 450 g) for ten minutes, resuspended in 1 ml of TCA and transferred to 10 mL of scintillation fluid (Optiphase 'Trisafe'). ³HTdR incorporation was measured by β-scintillation counting. The "Poly QTM" vials containing the samples and scintillation fluid were placed in the sample changer of the scintillator and left for approximately twenty minutes. The purpose of this period of time in darkness was to reduce the risk of luminescence, which has been shown to affect the reliability of the results. After approximately twenty minutes, the vials were shaken vigorously. The number of radioactive disintegrations per minute was then measured using the Beckman LS6500 scintillation system.
INTERPRETATION OF RESULTS
The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of ³HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test material 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 incorporation, will be classified as a "non-sensitiser". - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- none
Results and discussion
- Positive control results:
- Sensitising. See table 2.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Vehicle: N/A 5 % in vehicle: 3.55 10 % in vehicle: 6.87 25 % in vehicle: 14.75
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle: 6937.51 5 % in vehicle: 24627.15 10 % in vehicle: 47678.18 25 % in vehicle: 102309.20
Any other information on results incl. tables
Preliminary Screening Test
There were no signs of systemic toxicity noted.
Main Test
Estimation of the Proliferative Response of Lymph Node Cells
The radioactive disintegrations per minute (dpm) per lymph node and the stimulation index (SI) are given in Table 1.
A stimulation index of greater than 3 was recorded for the three concentrations of the test material (5%, 10% and 25% w/w in acetone/olive oil 4:1).
Clinical Observations, Bodyweights and Mortality Data
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the study. Brown-coloured staining was noted on the ears of all animals treated with the test material at a concentration of 25%. 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.
Table 1: Dpm, Dpm/Node and Stimulation Index (SI)
Concentration (% w/w) in acetone/olive oil 4:1 |
Dpm |
Dpm/Nodea |
Stimulation Index (SI)b |
Result |
Vehicle |
6937.51 |
867.19 |
N/A |
N/A |
5 |
24627.15 |
3078.39 |
3.55 |
Positive |
10 |
47678.18 |
5959.77 |
6.87 |
Positive |
25 |
102309.20 |
12788.65 |
14.75 |
Positive |
a = Dpm/node obtained by dividing the Dpm value by 8 (total number of lymph nodes)
b = Stimulation Index of 3.0 or greater indicates a positive result
N/A = Not applicable
Table 2: Stimulation Index for Positive Control
Concentration (% w/w) in acetone/olive oil 4:1 |
Stimulation Index (SI)b |
Result |
5 |
1.76 |
Negative |
10 |
2.78 |
Negative |
25 |
5.06 |
Positive |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test.
- Executive summary:
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The study was performed in accordance with the OECD 429 guideline and to GLP standard in a certified laboratory.
Following a preliminary screening test, three groups, each of four animals, were treated with 50 μL (25 μL per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 5 %, 10 % or 25 % w/w. A further group of four animals was treated with acetone/olive oil 4:1 alone.
Positive results were observed at all concentrations The test material was therefore considered to be a sensitiser under the conditions of the test.
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