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EC number: 943-286-0 | CAS number: 955359-35-0
- 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: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-09-13 to 2011-10-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July 2010
- 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,R-1-(4-tert-butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Molecular formula:
- C20H26O3
- IUPAC Name:
- R,R-1-(4-tert-butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Reference substance name:
- R,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Molecular formula:
- C20H26O3
- IUPAC Name:
- R,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Reference substance name:
- S,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Molecular formula:
- C20H26O3
- IUPAC Name:
- S,S-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Reference substance name:
- S,R-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Molecular formula:
- C20H26O3
- IUPAC Name:
- S,R-1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
- Test material form:
- solid
- Details on test material:
- Minimum purity 95% w/w
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- Designation: Art. 132720
Synonym: Avodiol
CAS-No.: 955359-35-0
Batch: 11/LE/016K1
Purity: 95.1% (w/w)
Appearance: white solid
Released until: 2012-05-18
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Manston Road, Margate, Kent, CT9 4LT, United Kingdom
- Age at beginning of treatment: 8- 10 weeks
- Body weight at beginning of treatment: 16.6 - 21.1 g
- Housing: group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:6 days prior start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5%
10%
25% - No. of animals per dose:
- Control group: 4/group
test item groups: 4/group - Details on study design:
- The study was performed according to OECD TG 429 (radioactive method).
The test item concentrations for the main study were established based on the results of a pre-test including ear thickness measurement using 2 mice. The radioactivity of the pooled lymph nodes were analyzed to investigate the skin sensitising potential of the test item. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 2.4
- Test group / Remarks:
- 25%
Any other information on results incl. tables
Study Design
In order to study a possible skin sensitising potential of the test
item, three groups each of four female mice were treated once daily with
the test item at concentrations of 5, 10, and 25% (w/v) in acetone:olive
oil (4:1, v/v) by topical application to the dorsum of each ear for
three consecutive days. A control group of four mice was treated with
the vehicle only. Five days after the first topical application the mice
were injected intravenously into a tail vein with radio-labelled
thymidine (3H-methyl thymidine). Approximately five hours after
intravenous injection, the mice were sacrificed, the draining auricular
lymph nodes excised and pooled per group. Single cell suspensions of
lymph node cells were prepared from pooled lymph nodes, which were
subsequently washed and incubated with trichloroacetic acid overnight.
The proliferative capacity of pooled lymph node cells was determined by
the incorporation of 3H-methyl thymidine measured in a
beta-scintillation counter.
Results
All treated animals survived the scheduled study period. Neither
clinical signs on the ears of the animals nor systemic findings were
observed during the study period. The results obtained (Stimulation
Index, SI) are reported in the following table.
Test item conc [%] | S.I. | |
Group 2 | 5 | 1.1 |
Group 3 | 10 | 1.4 |
Group 3 | 25 | 2.4 |
A calculation of the EC3 value was not performed as no test item
concentration produced a S.I. of 3 or higher.
Conclusion
The test item is not a skin sensitiser under the conditions of this study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not a skin sensitiser under the test conditions of this study and thus no classification for skin sensitisation is needed according to CLP-Regulation (EC) No 1272/2008.
- Executive summary:
see above
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