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EC number: 226-749-5 | CAS number: 5462-06-6
- 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:
- 25 Aug 2004 to 31 Aug 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study is conducted in 2004 before REACH required in vitro tests first (2016)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-(p-methoxyphenyl)-2-methylpropionaldehyde
- EC Number:
- 226-749-5
- EC Name:
- 3-(p-methoxyphenyl)-2-methylpropionaldehyde
- Cas Number:
- 5462-06-6
- Molecular formula:
- C11H14O2
- IUPAC Name:
- 3-(4-methoxyphenyl)-2-methylpropanal
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratories, Bar Harbor, ME 04609
- Age at study initiation: 9 to 11 weeks at start of dosing
- Weight at study initiation: 18 to 26 grams at the outset (Day 1) of the study
- Housing: Animals were group housed (5 per cage) upon receipt in compliance with National Research Council "Guide for the Care and Use of Laboratory Animals". No other species were kept in the same room.
- Diet: Animals had access to Certified Rodent Chow 7012C ad libitum.
- Water: Tap water was available ad libitum, via water bottles.
- Acclimation period: Study animals were acclimated to their housing for six to seven days prior to their first day of dosing.
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.7 to 25.6
- Humidity (%): 39 to 54
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: Diethyl phthalate/ethanol in a ratio of 3:1
- Concentration:
- 7.5, 15 and 30 %
- No. of animals per dose:
- 5
- Details on study design:
- JUSTIFICATION FOR DOSE LEVELS
Doses were selected by the sponsor. The highest dose that will be used in the intended application will not exceed 20%. However, as a conservative measure, and for a higher margin of safety, 30% was chosen as the high dose.
MAIN STUDY
Mice were treated on the dorsal surface of both ears, once per day on Days 1, 2, and 3. Approximately 24 ± 2 hours between applications of test article was maintained. On Day 6 the mice were injected i.v. with 20 pCi of 3H-thymidine in 250 µL of sterile saline. Five hours later the mice were euthanized by CO2 asphyxiation. Ear thickness measurements of each mouse were recorded and the draining auricular lymph nodes were removed. At removal, the number of nodes collected per animal were recorded, and the nodes were examined for size/appearance and the data recorded. Any unexpected observations were noted in study records. A single cell suspension was prepared from the lymph nodes of each mouse. Cells were washed twice with phosphate buffered saline (PBS) and precipitated with 5% trichloroacetic acid (TCA) overnight at 2-8 °C. The pellets were recovered by centrifugation and resuspended in 1 mL of TCA and transferred to a vial containing scintillation fluid. An additional 1 mL of TCA was used to rinse the tube, and was also transferred to the scintillation fluid. Incorporation of 3H-thymidine was measured in a ß-scintillation counter.
IN-LIFE OBSERVATIONS AND MEASUREMENTS
- Mortality/ morbidity: Daily on days 1 to 6.
- Clinical observations: Prior to dose administration and a minimum of once post-dose on Days 1 to 3. Clinical observations were also performed once daily on Days 4-6. Particular attention was given to the application sites.
- Body weight: Animals were weighed at the time of randomization/selection, and on Days 1 and 6 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- - The mean DPM for each group will be evaluated using SYSTAT version 9.01, developed by SPSS, Inc. Increases in 3H-thymidine incorporation relative to the vehicle-treated control will be derived for each group and recorded as stimulation indices (Sl).
- Individual DPM values will be analyzed by log transformation (base 10) of the data. The evaluation of the equality of means for the DPM, body weight and ear thickness data will be made by a one-way analysis of variance using the F distribution to assess statistical significance. If statistically significant differences between the means are found, a Dunnett's test will be used to determine the degree of significance from the control means.
- If the data indicates that the test article is positive, the EC3 will be calculated by the formula:
EC3 = c+[(3-d)/(b-d)](a-c)
where the data points lying immediately above and below the Sl value of 3 have the co-ordinates (a,b) and (c,d) respectively.
Results and discussion
- Positive control results:
- The positive control, 35% (v/v) HCA, resulted in a stimulation index (Sl) of 5.97. A 3-fold or greater increase in proliferative activity relative to the concurrent vehicle treated control is considered a positive response. In addition, the response with the positive control in this study was also statistically significant (p<0.001 ) when compared to the vehicle control group.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- other: NOEC
- Value:
- 15
- Remarks on result:
- other: 15%
- Key result
- Parameter:
- EC3
- Value:
- 23.63
- Parameter:
- SI
- Value:
- 1.51
- Remarks on result:
- other: 7.5%
- Parameter:
- SI
- Value:
- 2.01
- Remarks on result:
- other: 15%
- Parameter:
- SI
- Value:
- 3.73
- Remarks on result:
- other: 30%
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS AND MORTALITY:
There was no mortality and all animals appeared normal throughout the study. The application sites on the mice from the groups treated with the positive control appeared wet on Days 2-3. Wet appearance to the application sites was also observed in three animals treated with the test article at a concentration of 15% on Day 3. There were no other findings.
BODY WEIGHTS
Mean body weights at Day 1 and Day 6 and mean changes in body weights were evaluated. There were no statistically significant differences observed between any of the treatment groups. Therefore, the test article did not appear to cause any overt toxicity.
OTHER OBSERVATIONS
- At termination, the lymph nodes from the mice treated with the positive control were enlarged but appeared normal. The lymph nodes from the mice in the vehicle and all test article treated animals were normal in size and appearance.
- At termination both ears of each mouse were also measured. Statistically significant decrease (p < 0.01) in the ear measurements were observed in the group treated with 30% test article when compared to the vehicle group. However, this in not biologically significant.
Applicant's summary and conclusion
- Interpretation of results:
- other: skin sensitiser Category 1B
- Remarks:
- in accordance with EU CLP (1272/2008 and its updates)
- Conclusions:
- The SI values calculated for the substance concentrations 7.5, 15 and 30% were 1.51, 2.01, and 3.73, respectively. These results show that the test substance could elicit a SI ≥ 3. The calculated EC3 was 23.63% and therefore the test substance was considered to be a skin sensitiser 1B under the conditions of the test. The NOEC is 15%.
- Executive summary:
The skin sensitisation potential of the test substance has been tested using the Local Lymph Node Assay according to OECD TG 429 and GLP principles. The application of the test substance at concentrations of 7.5, 15 and 30% in a vehicle of Diethyl phthalate/ethanol in a ratio of 3:1 for three consecutive days did result in SI values of 1.51, 2.01, and 3.73, respectively. The calculated EC3 values was 23.63% and the NOEC is 15%. No mortality or toxicological relevant clinical observations and no effects on body weight were reported. Based on the results, the substance has to be classified as a skin sensitizer (category 1B).
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