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EC number: 218-002-7 | CAS number: 2035-93-0
- 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
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- january 8-14 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with standard test guidelines (OECD TG 429) and is GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
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:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-methyl-4-phenylpentan-2-ol
- EC Number:
- 218-002-7
- EC Name:
- 4-methyl-4-phenylpentan-2-ol
- Cas Number:
- 2035-93-0
- Molecular formula:
- C12H18O
- IUPAC Name:
- 4-methyl-4-phenylpentan-2-ol
- Test material form:
- other: clear liquid
- Details on test material:
- - Name of test material: 4-Methyl-4-phenyl-pentan-2-ol
- CAS number: 2035-03-0
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmBH, D-33178, Borchen
- Age at study initiation: 7-12 weeks
- Weight at study initiation:
- Housing: barrier maintained in an air conditioned room.
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: described as "adequate"
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22+/-3
- Humidity (%): 55+/-10%
- Air changes (per hr): at least 10/hr
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone :olive oil (AOO) 3:1
- Concentration / amount:
- 100% , 50 % and 10% w/w
Challenge
- Concentration / amount:
- 100% , 50 % and 10% w/w
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 on consecutive days
- Exposure period: 3 days
- Test groups: 3
- Control group: 1 - vehicle control
- Frequency of applications: daily
- Duration: single application
- Concentrations: 100%, 50 % and 10%
OTHER: - Challenge controls:
- Not applicable
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Vehicle:
- other: 3:1 (v/v) acetone/olive oil (AOO)
- Concentration:
- 10, 50 or 100%
- No. of animals per dose:
- 5
- Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph node assay
- Criteria used to consider a positive response: Three fold Stimulation Index (SI)of lymphocytes relative to controls
TREATMENT PREPARATION AND ADMINISTRATION:
A. INDUCTION EXPOSURE
- No. of exposures: 3 consecutive days
- Exposure period: 3 days
- Test groups: 3
- Control group: 1
- Site: dorsal surface of ear
- Frequency of applications: daily for 3 days
- Concentrations: 10, 50 or 100% - 25 microlites per ear
Five days after the first topical application all mice were injected intravenously with 3H-methyl thymidine. Approximately 5 hours after 3H-methyl
thymidine injection all mice were sacrificed and the draining „auricular lymph nodes" were excised and weighed individually, in order to prepare as
ingle cell suspension of the lymph node cells for each animal. The 3H-methyl thymidine — incorporation was measured in a ß-counter and
expressed as the number of disintegrations per rninute (DPM). Determination of radioactivity was performed individually for each animal. The
proliferative response of lymph node cells was calculated as the ratio of 3H-methyl thymidine - incorporation into lymph node cells of test group
animals relative to that recorded for control group animals. A stimulation index, ratio of test item / negative control, was calculated for each
concentration.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The ratio of 3H-methyl thymidine-incorporation into lymph node cells of test group animals, relative to that recorded for control group animals (stimulation index) for the test item was at a concentration of: 100 % 1.6 50% 1.4 10% 0.8 The EC3 value (derived by linear interpolation) could not be stated, because all measure points were below three.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean disintegrations per minute (DPM) per node were Control : 61.3 High dose :99.5 Mid dose : 87.9 Low dose : 50.8
Any other information on results incl. tables
Mean Stimulation index (SI)
Control = 1.0 (baseline)
100% = 1.6 (SD 0.6)
50% = 1.4 (SD 0.6)
10% = 0.8 (SD 0.3)
Mean lymph node weights of test groups
Control : 2.5mg
High dose : 3.7mg
Mid dose : 3.4mg
Low dose : 3.0 mg
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The stimulation index was below 3.0 for all concentrations tested, and so the test substance is not identified as skin sensitiser.
The proliferative response of lymph node cells was calculated as the ratio of 3H-methyl thymidine - incorporation into lymph node cells of test group animals relative to that recorded for control group animals. A stimulation index, ratio of test item / negative control, was calculated for each concentration.
The stimulation index at a concentration of 100 % was 1.6
The stimulation index at a concentration of 50 % was 1.4
The stimulation index at a concentration of 10 % was 0.8
The EC3 value (derived by linear interpolation) could not be determined as all measured points were below the stimulation index of three. - Executive summary:
The test item was assayed at three concentrations of 100 %, 50 % and 10 % (w/w) respectively. The vehicle was A00 (3+1 (v/v) Acetone/Olive Oil). Each mouse was treated by topical application with the prepared test item to the entire dorsal surface of each ear once daily over three consecutive days. Five days after the first topical application all mice were injected intravenously with 3H-methyl thymidine. Approximately 5 hours after 3H-methyl thymidine-injection all mice were sacrificed and the draining "auricular lymph nodes" were excised and weighed individually, in order to prepare a single cell suspension of the lymph node cells for each animal. The 3H-methyl thymidine-incorporation was measured in a ß-counter and expressed as the number of disintegrations per minute (DPM). Determination of radioactivity was performed individually for each animal. The proliferative response of lymph node cells was calculated as the ratio of 3H-methyl thymidine - incorporation into lymph node cells of test group animals relative to that recorded for control group animals. A stimulation index, ratio of test item /negative control, was calculated for each concentration.
The stimulation index at a concentration of 100 % was 1.6
The stimulation index at a concentration of 50 % was 1.4
The stimulation index at a concentration of 10 % was 0.8
The EC3 value (derived by linear interpolation) could not be determined as all measured points were below the stimulation index of three.
Conclusions
Considering the reported data of this sensitization test it can be stated that the test item causes no reactions identified as sensitization, as the stimulation index was below 3.0 for each concentration tested.
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