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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 221-410-8 | CAS number: 3087-36-3
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- . OECD Guideline 429 recommends that animals are housed individually, and that females are used.
- Principles of method if other than guideline:
- The study was designed to evaluate the effect of vehicles (ethanol or diethyl phthalate) for use in the mouse local lymph node assay.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- ethanol
- Details on test material:
- Ethanol (purity not given) supplied by Bush Boake Allen Limited (UK)
Constituent 1
Constituent 2
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 wk
- Weight at study initiation: not stated
- Housing: Groups of four animals per cage under standard conditions
- Diet (e.g. ad libitum): Pelleted diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): Fluorescent light - 12-hr dark/12-hr light cycle
Study design: in vivo (LLNA)
- Vehicle:
- unchanged (no vehicle)
- No. of animals per dose:
- 4
- Details on study design:
- Four alternative vehicles (ethanol; 3:1 ethanol:diethyl phthalate; 1:3 ethanol:diethyl phthalate; and diethyl phthalate) were evaluated for their utility in the LLNA, and their influence on the skin sensitization potential of four test fragrance materials (p-t-butyl-alpha-methylhydrocinnamic aldehyde; geraniol; eugenol; and hydroxycitronellal). Groups of four male mice were treated with each test fragrance, at one of five concentrations, in one of the four vehicles or to the same volume of the vehicle (ethanol or diethyl phthalate) alone (see Table 1 for further details). Stimulation Index (SI), as a measure of T-lymphocyte proliferation, was calculated for each concentration of test fragrance relative to the concurrent vehicle-treated animals.
- Positive control substance(s):
- other: The test fragrances used in the study (p-t-butyl-alpha-methylhydrocinnamic aldehyde; geraniol; eugenol; and hydroxycitronellal) effectively acted as positive controls; they are all known to be mild to moderate sensitizers.
- Statistics:
- SI values for the test fragrances were compared using an analysis of variance. Estimated concentrations of test fragrances required to elicit as SI of 3 or more (EC3 value) were also calculated using dose-response data. As ethanol was tested as a vehicle control in this study, there was no appropriate comparison with untreated animals (or with the alternative vehicle used, diethyl phthalate).
Results and discussion
- Positive control results:
- Although not true positive controls, the test fragrances clearly induced dose-related stimulation of T-lymphocyte proliferation (see Table 1).
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- >= 133 - <= 175
- Test group / Remarks:
- Ethanol
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- >= 185 - <= 267
- Test group / Remarks:
- diethyl phthalate
Any other information on results incl. tables
Although the study was not specifically designed to assess the sensitizing potential of ethanol, it is clear from the results (Table 1) that the level of induced T-lymphocyte proliferation (a necessary component of contact sensitization) in the lymph node draining the site of topical chemical application was low (as measured by the incorporation of radiolabelled thymidine into the dividing cells) for ethanol when compared with that for fragrance materials known to be mild to moderate skin sensitizers, and comparable to that for the other (negative) control vehicle tested, diethyl phthalate. In addition, there was no discernable induction (increase in cpm/node) across the four test fragrance control series when the ethanol concentration (in diethyl phthalate) was 0% [100% diethyl phthalate], 33% [1:3 ethanol:diethyl phthalate], 67% [3:1 ethanol:diethyl phthalate], and 100%, which would be expected were ethanol a significant skin sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A study was carried out to evaluate the effect of vehicles (ethanol or diethyl phthalate) for use in the mouse local lymph node assay (LLNA). Based on the study results it was concluded that ethanol is not sensitising.
- Executive summary:
A study was carried out to evaluate the effect of vehicles (ethanol or diethyl phthalate) for use in the mouse local lymph node assay (LLNA), and their influence on the skin sensitization potential of four test fragrance materials (p-t-butyl-alpha-methylhydrocinnamic aldehyde; geraniol; eugenol; and hydroxycitronellal). Groups of 4 mice were treated with each test fragrance, at one of five concentrations, either in ethanol or diethyl phthalate (and 1:3 or 3:1 mixtures of the two), or with ethanol (or diethyl phthalate) alone. Although there were no true control data for comparison with the ethanol-alone treated animals, the level of induced T-lymphocyte proliferation was low for ethanol when compared with that for fragrance materials known to be mild to moderate skin sensitizers, and comparable to that for the other (negative) control vehicle tested, diethyl phthalate. The investigators concluded that ethanol is an appropriate vehicle for use in the LLNA and is a suitable alternative to the current guideline recommended vehicles. A prerequisite for use as a vehicle would be a lack of sensitizing potential itself.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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