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EC number: 203-273-6 | CAS number: 105-13-5
- 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:
- 09 July 2004 and 25 January 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
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:
- 4-methoxybenzyl alcohol
- EC Number:
- 203-273-6
- EC Name:
- 4-methoxybenzyl alcohol
- Cas Number:
- 105-13-5
- Molecular formula:
- C8H10O2
- IUPAC Name:
- (4-methoxyphenyl)methanol
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 Interfauna UK Limited, Blackthorne, Bicester, Oxon, UK
- Age at study initiation: 8-12 weeks
- Housing: a maximum of 4 mice was housed per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: 1:3 ethanol/diethyphthalate (EtOH/DEP)
- Concentration:
- 2.5, 5.0, 10, 25 and 50% (w/w)
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay
- Criteria used to consider a positive response: 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:
- All dose preparations were used within 24 hours of preparation.
- Approximately, 25 µL of the test substance in vehicle was applied, using a variable volume micro-pipette, to the dorsal surface of each ear. The procedure was repeated daily for 3 consecutive days. Three days after the third application, all animals were injected, via the tail vein, with approximately 250 µL of phosphate buffered saline (PBS) containing 20µCi of a 2.0Ci/mmol specific activity 3H-methyl thymidine. Approximately 5 hours later, the animals were humanely killed. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A greater than 3-fold increase in isotope incorporation was observed at both 10% and 25% concentrations of positive control in acetone:olive oil (4.1).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 5.9
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 2.5% test item
- Key result
- Parameter:
- SI
- Value:
- 2.8
- Test group / Remarks:
- 5% test item
- Key result
- Parameter:
- SI
- Value:
- 3.9
- Test group / Remarks:
- 10% test item
- Key result
- Parameter:
- SI
- Value:
- 5.1
- Test group / Remarks:
- 25% test item
- Key result
- Parameter:
- SI
- Value:
- 5.3
- Test group / Remarks:
- 50% test item
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
The following disintegrations per minute (DPM) were determined:
vehicle: 2651 dpm
2.5% test item: 4620 dpm
5.0% test item: 7319 dpm
10 % test item: 10242 dpm
25% test item: 13609 dpm
50% test item: 14025 dpm
EC3 CALCULATION: EC3 = [(3-d)/(b-d)] x (a-c) + c with a: concentration giving the SI immediately above 3), b: SI of a, c: concentration giving the SI immediately below 3, d: SI of c
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test item is likely to be a skin sensitiser under the conditions of the test. The EC3 value was calculated to be 5.9% w/v (1475 µg/cm2).
- Executive summary:
The test substance was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay: The assay determines the level of T lymphocyte proliferation in the lymph nodes draining the site of chemical application, by measuring the amount of radiolabelled thymidine incorporated into the dividing cells. The test item was applied as 2.5, 5, 10, 25 or 50% w/v preparations in 1:3 ethanol:diethylphthalate. A vehicle control was similarly treated using 1:3 EtOH:DEP alone. The test substance caused skin sensitisation when applied as a 10, 25 and 50% (w/v) preparation in 1:3 EtOH:DEP. The EC3 value giving rise to a 3 fold increase in lymphocyte proliferation was calculated to be 5.9% w/v (1475 µg/cm2). The positive control, hexycinnamaldehyde caused skin sensititsation when applied as 10% or 25% preparations in acetone:olive oil (4:1), confirming the validity of the test. In conclusion, the test substance is considered to be a skin sensitiser under the test conditions.
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