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EC number: 202-859-9 | CAS number: 100-51-6
- 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:
- weight of evidence
- Study period:
- July 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Additionally the study was reviewed by an external expert (R.J. Dearman, University of Manchester, Division of Infection, Immunity & Respiratory Medicine)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- (2002)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Benzyl alcohol
- EC Number:
- 202-859-9
- EC Name:
- Benzyl alcohol
- Cas Number:
- 100-51-6
- Molecular formula:
- C7H8O
- IUPAC Name:
- phenylmethanol
- Details on test material:
- no further information
Constituent 1
- Specific details on test material used for the study:
- Purity: 99.8%, a certificate of analysis was provided to the test institute by the sponsor
- Stability under test conditions: No information on testing of stability of the test substance in the vehicle is provided in the report, however, all dose preparations were prepared freshly before dosing (all dose preparations were used within 24 hours of preparation).
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: CBA/Ca/Ola/Hsd
- Source:Harlan Interfauna UK Limited, Blackthorne, Bicester, Oxon, UK
- Age at study initiation: 8–12 weeks
- Weight at study initiation: 17.3-22.8 g
- Housing: a maximum of 4 mice was housed per cage
- Diet and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): a minimum of 15 changes/hour
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: 1:3 Ethanol : Diethyl phthalate
- Remarks:
- Rational for the vehicle chosen: Betts CJ, Contact Dermatitis 56, 70-75, 2007
- Concentration:
- 2.5, 5, 10, 25, and 50 % w/v
- No. of animals per dose:
- 4
- Details on study design:
- Approximately 25µL of a 2.5, 5, 10, 25 or 50% w/v preparation of the test substance in 1:3 EtOH:DEP was applied, using a variable volume micro-pipette, to the dorsal surface of each ear. A vehicle control group was similarly treated using 1 : 3 EtOH:DEP alone. The procedure was repeated daily for 3 consecutive days.
Three days after the third application, all the animals were injected, via the tail vein, with approximately 250µL of phosphate buffered saline (PBS) containing 20 µCi of a 2.0 Ci/mmol
specific activity 3H-methyl thymidine. Approximately 5 hours later, the animals were humanely killed by inhalation of halothane vapour followed by cervical dislocation. The draining auricular lymph nodes were removed from each animal and, together with the nodes from the other animals in the group, were placed in a container of PBS.
A single cell suspension was prepared by mechanical disaggregation of lymph nodes through a 200-mesh stainless steel gauze. The cell suspensions were then washed three times by centrifugation with approximately 10 ml of PBS. Approximately 3 ml of 5 % w/v trichloroacetic acid (TCA) was added and, after overnight precipitation at 4 °C, the samples were pelleted by centrifugation and the supematant was discarded. The cells were then resuspended in approximately 1ml of TCA.
The lymph node suspensions were transferred to scintillation vials and 10 ml of scintillant (Optiphase) was added prior toP-scintillation counting using a Packard Tri-Carb Liquid Scintillation Counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The application of hexylcinnamaldehyde at concentrations of 5 %, 10 %, and 25 % w/v on acetone:olive oil (4:1) resulted in a greater than 3-fold increase in isotope incorporation at both 10 % and 25 % concentrations. Therefore, hexylcinnamaldehyde was shown to be a skin sensitizer, confirming the validity of the protocol used for this study.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 2.5 % (w/v)
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 5 % (w/v)
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- 10 % (w/v)
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 25 % (w/v)
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 50 % (w/v)
- Parameter:
- EC3
- Remarks:
- (%)
- Value:
- > 50
- Test group / Remarks:
- Estimated EC3, since test substance concentration up to 50 % caused no SI value increase greater than 3-fold.
- Cellular proliferation data / Observations:
- Benzyl alcohol in 1:3 EtOH:DEP did not have the capacity to cause skin sensitization at any of the doses applied. The EC3 value giving rise to a 3-fold increase in lymphocyte proliferation was estimated to be greater than 50 % w/v (greater than 12500 µg/cm²).
Effects on body weight/body weight gain or on general condition were not reported.
Any other information on results incl. tables
Conc. of test substance (% w/v) | Number of lymph nodes assayed | dpm | dpm per lymph node | Test:control ratio |
0 (vehicle only) | 8 | 2248 | 281 | N/A |
2.5 | 8 | 2289 | 286 | 1.0 |
5 | 8 | 1975 | 247 | 0.9 |
10 | 8 | 1191 | 149 | 0.5 |
25 | 8 | 1420 | 178 | 0.6 |
50 | 8 | 2635 | 329 | 1.2 |
EC3 | Estimated to be greater than 50 % w/v (> 12500 µg/cm²) |
Applicant's summary and conclusion
- Executive summary:
A LLNA on female CBA/Ca/Ola/Hsd-mice revealed no 3 -fold increase in lymphocytes after substance application at concentrations of 2.5, 5, 10, 25, and 50 % and thus no indication for a sensitising potential of the substance.
Hexyl cinnamaldehyde as positive control showed the expected positive result after application of a 10 or 25 % formulation in acetone:olive oil 4:1, confirming thus the validity of the protocol used for this study.
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