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EC number: 204-602-6 | CAS number: 123-11-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Anisaldehyde
- EC Number:
- 204-602-6
- EC Name:
- Anisaldehyde
- Cas Number:
- 123-11-5
- Molecular formula:
- C8 H8 O2
- IUPAC Name:
- 4-methoxybenzaldehyde
- Details on test material:
- - Name of test material (as cited in study report): p-Methoxybenzaldehyde
- Physical state: Colourless/ yellowish liquid
- Analytical purity: 99.71%
- Lot/batch No.: 55
- Sample: Y14020/001
- Expiration date of the lot/batch: 14th March 2007
- Storage condition of test material: Ambient temperature in the dark
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
- Source: Charles River UK Ltd., Manston Road, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Housing: A maximum of 4 mice was housed per cage, in cages suitable for animals of this strain and weight range. Environmental enrichment provided included tents, bases and nestlets.
- Diet: RM1, supplied by Special Diet Services Limited, Witham, Essex, UK; ad libitum
- Water: mains water, supplied by an automatic system; 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:diethylphthalate (1:3 EtOH:DEP)
- Concentration:
- 0 (vehicle control), 1, 2.5, 5, 10, 25%
- No. of animals per dose:
- 4
- Details on study design:
- 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 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 10mL of PBS. Approximately 3mL of 5% w/v trichloroacetic acid (TCA) was added and, after overnight precipitation at 4°C, the samples were pelleted by centrifugation and the supernatant was discarded. The cells were then resuspended in approximately 1 mL of TCA.
The lymph node suspensions were transferred to scintillation vials and 10mL of scintillant (Optiphase) was added prior to beta-scintillation counting using a Packard Tri-Carb 3100TR Liquid Scintillation Counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The estimated concentration of the test material required to produce a 3-fold increase in the draining lymph node cell proliferative activity (EC3) was calculated by interpolating between two SI points using the following equation; EC3 = [(3 – d)/(b – d)] x (a – c) + c, where a = concentration with SI immediately above 3, b = SI of a, c = concentration with SI immediately below 3, and d = SI of c.
Results and discussion
- Positive control results:
- Application of hexylcinnamaldehyde at concentrations of 5%, 10% or 25% resulted in an SI of 1.7, 2.3 or 6.4, respectively, confirming the validity of the study protocol.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The application of the test substance at concentrations of 1, 2.5, 5, 10 or 25 %w/v in 1:3 EtOH:DEP resulted in an isotope incorporation which was less than 3-fold at all concentrations: 1%: the test material was not considered a skin sensitizer at 1% with a stimulation index of 1.4. 2.5%: the test material was not considered a skin sensitizer at 2.5% with a stimulation index of 1.0. 5%: the test material was not considered a skin sensitizer at 5% with a stimulation index of 1.1. 10%: the test material was not considered a skin sensitizer at 10% with a stimulation index of 1.5. 25%: the test material was not considered a skin sensitizer at 25% with a stimulation index of 1.5.
Any other information on results incl. tables
Concentration (% w/v) | Nr of lymph nodes assessed | DPM | DPM per lymph node | SI |
0,0 | 8 | 2816 | 352 | - |
1,0 | 8 | 4066 | 508 | 1.4 |
2,5 | 8 | 2795 | 349 | 1.0 |
5,0 | 8 | 3152 | 394 | 1.1 |
10,0 | 8 | 4136 | 517 | 1.5 |
25,0 | 8 | 4322 | 540 | 1.5 |
The EC3 value is estimated to be greater than 25% (6250 µg/cm2).
---
Irritancy scoring
The application of the test substance at concentrations of 1, 2.5, 5, 10 or 25 %w/v in 1:3 EtOH:DEP resulted in some signs of irritancy (mild irritation) to the skin on or around the ear area on days 3 and 6 for all four animals of the 10 and 25 %w/v dose groups, respectively.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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