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EC number: 243-349-6 | CAS number: 19819-98-8
- 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:
- 16 September 2003 - 19 January 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-phenylethanol
- EC Number:
- 200-456-2
- EC Name:
- 2-phenylethanol
- Cas Number:
- 60-12-8
- Molecular formula:
- C8H10O
- IUPAC Name:
- 2-phenylethanol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/Ca/Ola/Hsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Harlan Interfauna UK Limited, Blackthorne, Bicester, Oxon, UK. - Age at study initiation: Young adults- Weight at study initiation: No data- Housing: 4 animals/ cage- Diet (e.g. ad libitum): Ad libitum- Water (e.g. ad libitum): Ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 - Humidity (%): 30-70- Air changes (per hr): minimum of 15- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/diethylphthalate 1:3
- Concentration:
- 2.5%, 5%, 10%, 25% or 50% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:Not performed.MAIN STUDY- Clinical observations: All animals were observed at least once daily for signs of systemic toxicity.- Body weights: The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination).ANIMAL ASSIGNMENT AND TREATMENT- Criteria used to consider a positive response: 3-fold or greater increase in dpm as compared to the control group (Stimulation Index > 3)TREATMENT PREPARATION AND ADMINISTRATION:- In accordance with OECD TG 429.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The EC3 value was derived by interpolating between two points on the Stimulation Index (SI) axis, one immediately above and the other immediately below the SI value of 3. These datapoints have the co-ordinates "a" (concentration at SI immediately above 3), "b" (SI of "a"), c (concentration at SI immediately below 3) and d (the SI of "c"), which are used to calculate the EC3 value by use of the standardfollowing equation: EC3=[(3-d)/(b-d)]x(a-c)+c.
Results and discussion
- Positive control results:
- The application of the positive control item, Hexylcinnamaldehyde, resulted in a more than 3-fold increase in isotope incorporation for all three tested concentrations (SI > 6).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Test group / Remarks:
- All test groups
- Remarks on result:
- not determinable
- Remarks:
- All SI < 3
- Parameter:
- SI
- Value:
- 1.06
- Test group / Remarks:
- 2.5% (w/v)
- Parameter:
- SI
- Value:
- 1.01
- Test group / Remarks:
- 5% (w/v)
- Parameter:
- SI
- Value:
- 0.87
- Test group / Remarks:
- 10% (w/v)
- Parameter:
- SI
- Value:
- 0.95
- Test group / Remarks:
- 25% (w/v)
- Parameter:
- SI
- Value:
- 0.84
- Test group / Remarks:
- 50% (w/v)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATAMean DPM at 0 (vehicle), 2.5, 5, 10, 25 and 50% (w/v) were 5432, 5776, 5504, 4709, 5167 and 4536, respectively.DETAILS ON STIMULATION INDEX CALCULATIONThe following SI values were derived at 2.5, 5, 10, 25 and 50% (w/v): 1.06, 1.01, 0.87, 0.95, 0.84. EC3 CALCULATIONThe EC3 value could not be calculated because there were no concentrations tested that resulted in an SI ≥ 3. The EC3 value is therefore expected to be above 50% (w/v).CLINICAL OBSERVATIONS:No clinical signs reported.BODY WEIGHTS:Only raw data reported.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not skin sensitizer
- Remarks:
- According to EU CLP 1272/2008 and its amendments.
- Conclusions:
- Under the conditions of this test, Etaphen did not induce a Stimulation Index (SI) above 3 and an EC3 value could not be calculated (>50%). Based on these results, the substance is considered not to be a sensitiser and does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP) and its amendments.
- Executive summary:
The skin sensitisation potential of Etaphen has been tested according to OECD TG 429: Local Lymph Node Assay in mice. At doses of 2.5, 5, 10, 25 and 50% (w/v), the substance induced SI values of 1.06, 1.01, 0.87, 0.95 and 0.84, respectively. The EC3 could not be calculated as there were no concentrations tested that resulted in an SI ≥ 3. Based on these results, the substance is considered not to be a sensitiser and does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP)
and its amendments
.
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