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EC number: 929-946-0 | CAS number: -
- 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:
- 2008-04-22 to 2008-05-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenol
- EC Number:
- 929-946-0
- Cas Number:
- 286930-02-7
- Molecular formula:
- C22 H31 N O2
- IUPAC Name:
- (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Sponsor and 902/695838/D/2/1
RADIOLABELLING INFORMATION
- Specific activity: 2.0 Ci/mmol
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: approximately 4°C in the dark
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in the vehicle at desired dosing concentration
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Dissolved in dimethyl formamide
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Dissolved in dimethyl formamide at 50 and 25% w/w test ingredient to vehicle for preliminary screening
Dissolved in dimethyl fornamide at 25, 10, and 5% w/w test ingredient to vehicle for the main test
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, UK
- Females nulliparous and non-pregnant:yes
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 15 to 23 g
- Housing: Suspended solid-floor polypropylene cages furnished with softwood woodflake
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 50 and 25% w/w test ingredient to vehicle for preliminary screening
25, 10, and 5% w/w test ingredient to vehicle for the main test - No. of animals per dose:
- 1 female for the preliminary study
5 females for the main test (including vehicle control) - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: Compound was completely soluble to dosing level necessary (50% w/w test ingredient to vehicle)
- Systemic toxicity: The animal treated with the test material at a concentration of 50% w/w in dimethyl formamide was humanely killed, pre-dose on Day 3, due to the occurrence of clinical signs of toxicity that approached the moderate severity limit set forth in the UK Home Office Project Licence. Signs of systemic toxicity noted were hunched posture, lethargy and ptosis.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph nodes from each individual animal and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3 HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3 HTdR incorporation will be classified as a "non-sensitiser".
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of five mice were treated with the test material at concentrations of 5%, 10% or 25% w/w in dimethyl foimamide. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 .il of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of five mice received the vehicle alone in the same manner.
Five days following the first topical application of the test material (Day 6) all mice were injected via the tail vein with 250 tl of phosphate buffered saline (PBS) containing 3 H-methyl thymidine (3 HTdR:80uCiiml, specific activity 2.0 Ci/mmol, GE Healthcare UK Ltd) giving a total of 20 to each mouse.
Clinical Observations: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
Bodyweights: The bodyweight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Data was processed to give group mean values for disintegrations per minute and standard deviations where appropriate. Individual and group mean disintegrations per minute values were assessed for dose response relationships by analysis of homogeneity of variance followed by one way analysis of variance (ANOVA). In the event of a significant result from the ANOVA, pairwise comparisons were performed between control and treated groups. For homogenous datasets Dunnett's Multiple Comparison test was used and for non-homogenous datasets Dunnett's T3 Multiple Comparison Method was used.
Results and discussion
- Positive control results:
- The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (%v/v) in dimethyl formamide Stimulation Index Result
5 2.05 Negative
10 3.52 Positive
25 6.87 Positive
Based on this information the dose levels selected for the main test were 25%, 10% and 5% w/w in dimethyl formamide.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 0
- Test group / Remarks:
- Test Group 1 - 5 females - negative control
- Key result
- Parameter:
- SI
- Value:
- ca. 16.9
- Variability:
- Significantly different from control group p<0.01
- Test group / Remarks:
- Test Group 2 - 5 females - 5% w/w test ingredient in dimethyl fornamide
- Key result
- Parameter:
- SI
- Value:
- ca. 20.3
- Variability:
- Significantly different from control group p<0.01
- Test group / Remarks:
- Test Group 3 - 5 females - 10% w/w test ingredient in dimethyl fornamide
- Key result
- Parameter:
- SI
- Value:
- ca. 24.14
- Variability:
- Significantly different from control group p<0.001
- Test group / Remarks:
- Test Group 4 - 5 females - 25% w/w test ingredient in dimethyl fornamide
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph nodes from each individual animal and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3 HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3 HTdR incorporation will be
classified as a "non-sensitiser".
CLINICAL OBSERVATIONS: There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHTS Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test material was classified as a contact sensitiser (Category 1) according to the GHS criteria.
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