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Diss Factsheets
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EC number: 203-518-7 | CAS number: 107-75-5
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Ethanol and Diethyl Phthalate: Vehicle Effects in the Local Lymph Node Assay
- Author:
- Lalko J, Isola D, and Api AM
- Year:
- 2 004
- Bibliographic source:
- International Journal of Toxicology 23: 171-177
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- acc. Kimber et al. (1992, 1994).
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 7-hydroxycitronellal
- EC Number:
- 203-518-7
- EC Name:
- 7-hydroxycitronellal
- Cas Number:
- 107-75-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 7-hydroxy-3,7-dimethyloctanal
- Details on test material:
- - Name of test material (as cited in study report): hydroxycitronellal
- Supplier: Bush Boake Allen Limited, UK
- Analytical purity: 98.7 %
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK, Shaw's Farm, Blackthorne, Bicester, Oxon, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 17 - 21 g
- Housing: groups of 4 per cage
- Diet (e.g. ad libitum): ad libitum, Porton combined Diet, pelleted diet; Special Diets Services Ltd., Witham, UK
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- other: Diethyl phtalate (DEP); 1:3 Ethanol:DEP; 3:1 Ethanol:DEP; Ethanol
- Concentration:
- 0%, 1%, 3%, 10%, 30%, 50%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: A material was considered a sensitizer if at least one concentration of the test material was observed to have an stimulation index (SI) value of 3 or more. The EC3 value, or estimated concentration of test material required to elicit an SI of 3 or more, was derived from the dose-response data by linear interpolation. EC3 value was calculated utilizing the equation presented by Basketter et al. (1999)
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of 4 male mice were dosed at one of five concentrations in one of four vehicles or to the same volume of the vehicle alone, which acted as the control. Dosing occurred daily for 3 consecutive days.
The animals "rested" for 2 days and on the 6th day after the first application, all mice were injected intravenously by the tail vein with 250 µl of phosphate-buffered saline (PSB) containing 20 µCi of [3H] methyl thymidine (3HTdR; specific activity 2.0 Ci/mmol).
Five hours later, the mice were euthanized and the draining auricular lymph nodes were excised and pooled for each experimental group.
Suspensions of the lymph node cells were prepared by mechanical disaggregation through 200 mesh stainless steel gauze.
The cell suspensions were washed three times with PBS and precipitated overnight at 4 C with 5% w/v trichloroacetic acid (TCA).
The samples were then pelleted by centrifugation. The cells were resuspended in 1 ml of TCA and transferred to scintillation vials containing 10 ml of scintillation fluid. The incorporation of 3HTdR was measured by beta-scintillation counting expressed as counts per minute (cpm) per lymph node for each experimental group.
For each concentration of test material, a stimulation index (SI) relative to the concurrent vehicle-treated control was calculated.
The SI value for each test material was calculated by dividing the mean cpm at a given dose level by the mean cpm of the vehicle control group. - Statistics:
- SI values greater than or equal to 3 are considered to result in a positive response. The SI is calculated by dividing the mean cpm at a given dose level by the mean cpm of the vehicle control group.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: SI (0%, 1%, 3%, 10%, 30%, 50%): - DEP: na, 1.3, 1.5, 1.8, 4.2, 5.3 - 1:3 Ethanol:DEP: na, 1.1, 0.9, 2.1, 4.0, 6.2 - 3:1 Ethanol:DEP: na,1.6, 1.6, 1.4, 4.0, 5.8 - Ethanol: na, 1.3, 1.0, 1.6, 3.3, 7.2
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Hydroxycitronellal showed in all four vehicles a positive response at 30 and 50 % (w/v). DPM (0%, 1%, 3%, 10%, 30%, 50%): - DEP: 267, 345, 391, 495, 1128, 1405 - 1:3 Ethanol:DEP: 241, 275, 225, 507, 971, 1491 - 3:1 Ethanol:DEP: 145, 232, 234, 207, 582, 843 - Ethanol: 175, 223, 181, 276, 579, 1264
Any other information on results incl. tables
The sensitization potential of the test material hydroxycitronellal was greatest
when the vehicle was 1:3 Ethanol:DEP.
The strength of the sensitization response was observed to vary with the vehicle.
Derived EC3 values:
1. diethyl phthalate (DEP): 19.7%
2. ethanol:diethyl phthalate 3:1: 22.2%
3. ethanol:diethyl phthalate 1:3: 19.3%
4. ethanol: 26.4%
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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