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EC number: 231-335-2 | CAS number: 7493-74-5
- 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:
- 07 Mar - 13 Mar 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Allyl phenoxyacetate
- EC Number:
- 231-335-2
- EC Name:
- Allyl phenoxyacetate
- Cas Number:
- 7493-74-5
- Molecular formula:
- C11H12O3
- IUPAC Name:
- allyl phenoxyacetate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 18.1-23.7 g
- Housing: maximum 4 animals per cage in cages suitable for animals of this strain and weight range, tents and nestlets as cage-enrichment
- Diet: RM1 (Special Diet Services Limited, Witham UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/diethyl phthalate (1:3) (test substance); acetone/olive oil (4:1) (positive control substance)
- Concentration:
- Test substance: 0.5, 1, 2.5, 5 and 10% (w/v)
Positive control: 5, 10 and 25% (w/v) - No. of animals per dose:
- 4
- Details on study design:
- ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-methyl thymidine incorporation determined by ß-scintillation
- Criteria used to consider a positive response: A stimulation index (SI) was calculated for each group using the activity of each test group divided by the activity of the vehicle control group. The criterion for a positve response is that one or more concentrations of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group.
TREATMENT PREPARATION AND ADMINISTRATION: The dorsal surface of both ears was topically treated (25 μL/ear) with the test substance concentration. The application was repeated daily for 3 consecutive days; local irritation reactions were assessed. Three days after the third application an injection of 250 µl phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (³HTdR) was made into the tail vein of each experimental mouse. Approximately five hours later, following injection of ³HTdR, the mice were euthanized and draining auricular lymph nodes were excised and pooled for each test group. A single cell suspension of pooled lymph node cells was prepared in PBS by gentle separation through a 200-mesh stainless steel gauze. The cell suspensions were washed three times by centrifugation with approximately 10 mL PBS. To precipitate the DNA, the cell suspensions were exposed to 3 mL of 5% trichloroacetic acid and stored at 4 °C overnight. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The calculation of the EC3 value was conducted by linear interpolation according to the equation:
EC3 = [(3-d)/(b-d)] x (a-c) + c
where the data points lying immediately above and below the SI value of 3 on the LLNA dose-response plot have the co-ordinates a (the concentration giving the SI immediately above 3), b (the SI of a), c (the concentration giving the SI immediately below 3) and d (the SI of c).
Results and discussion
- Positive control results:
- The SI values calculated for the positive control at concentrations of 5, 10 and 25% (w/v) were 1.7, 2.3 and 6.4 respectively. The application at concentration of 25% resulted in a greater than 3-fold increase in isotope incorporation at this concentration.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 0.5% (w/v)
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 1% (w/v)
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 2.5% (w/v)
- Parameter:
- SI
- Value:
- 7.5
- Test group / Remarks:
- 5% (w/v)
- Parameter:
- SI
- Value:
- 8.1
- Test group / Remarks:
- 10% (w/v)
- Parameter:
- EC3
- Value:
- 3.1
- Cellular proliferation data / Observations:
- IRRITATION
The application of the test substance at concentrations of 0.5, 1, 2.5, 5 and 10% (w/v) in ethanol/diethyl phthalate (1:3) did not result in an increase in visual levels of irritancy to the skin on or around the ear area apart from on Day 3, where slight reddening of the ear skin at the 5 and 10% dose groups was observed. This had resolved by Day 6.
CELLULAR PROLIFERATION DATA
The lymph nodes of all animals per group were pooled and DPM values were measured from the pooled lymph node cell suspensions. Treatment with test substance concentrations of 0.5, 1, 2.5, 5 and 10% (w/v) in ethanol/diethyl phthalate (1:3) resulted in DPM values per lymph node of 284, 473, 560, 2642 and 2856, respectively. The DPM value per lymph node of the vehicle control was 353.
EC3 CALCULATIONE: EC1.6 =[(3-d)/(b-d)] x (a-c) + c
a= The dose concentration with SI above 3; b = The SI value of a, c = The dose concentration with SI lower 3; d = The SI value of c
EC3 = 3.1
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Sens Cat 1B is required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the mouse Local Lymph Node Assay the test substance revealed sensitising properties. The EC3 value was calculated to be 3.1% hence, the test substance was assessed to be a weak sensitiser (Skin Sens. 1B).
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