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Diss Factsheets
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EC number: 914-467-1 | 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study (OECD TG 429)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to §19 German Chemikaliengesetz
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Montan waxes, Type E
- IUPAC Name:
- Montan waxes, Type E
- Details on test material:
- - Name of test material (as cited in study report): Licowax E FL
- Physical state: solid
- Stability under test conditions: at least one week in acetone/olive oil 4:1 (v/v)
- Storage condition of test material: room temperature
- Test item was extracted in acetone acetone/olive oil 4:1 (v/v) at a weight per volume ratio of 0.2 g/ml for 72 h at 37 °C
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 Netherlands, Horst, Netherlands
- Age at study initiation: 8-12 weeks
- Housing: individually in Macrolon cages
- Diet: standard diet, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, 100% extract of test item (extracted at a weight per volume ratio of 0.2 g/mL in acetone:olive oil (4:1) for 72 h at 37 °C)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: two mice with concentrations of 10, 25, 50 and 100% (non GLP pre-test)
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one extract concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Three groups each of four female mice were treated with different concentrations of the test item extract by topical application at the dorsum of each ear lobe (left and right) an 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 intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and 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 ß-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in body weight tables.
A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3 value was calculated according to the equation
EC3 = (a-c) [(3-d)/(b-d)] + c where EC3 is the estimated extract concentration of the test item required to produce a 3- fold increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the S.I. value of 3 an the local lymph node assay dose response plot.
The EC3 value of the test item could not be calculated, since all stimulation indices were below 3.
Results and discussion
- Positive control results:
- Stimulation Indices:
5%: 2.0
10%: 3.0
25%: 4.9
EC3: 9.9%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 25%: 2.5 50%: 2.3 100%: 2.3 The EC3 could not be calculated
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Background: 0; 0.2 (mean: 0,.1) Control group: 2552.9; -Background: 2552.8 (8 lymph nodes pooled) 25%: 6382.3; -Background: 6382.2 (8 lymph nodes pooled) 50%: 5883.7; -Background: 5883.6 (8 lymph nodes pooled) 100%: 5852.0; -Background: 5851.9 (8 lymph nodes pooled)
Any other information on results incl. tables
No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. The body weights of the animals, recorded prior to the 1st application and prior to necropsy was within the range commonly recorded for animals of this strain and age.
No systemic findings were observed during the study period. After the last treatment a slight reddening of the ears was observed in 2 animals treated with the undiluted extract, one animal treated with the 50% extract and two animals treated with the 25% extract. This observation is, however, due to its lack of severity not biologically relevant.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An extract of Licowax E FL (25-100%) was not sensitising in a Local Lymph Node Assay in mice under the conditions of this study (extracted in acetone:olive oil (4:1) for 72 h at 37 °C).
- Executive summary:
In the study the test item Licowax E FL extracted in acetone:olive oil (4:1) was assessed for its possible contact allergenic potential.
For this purpose the test item was extracted at a weight per volume ratio of 0.2 g/mL in acetone:olive oil (4:1) for 72 h at 37 °C. A local lymph node assay was performed using test item extract concentrations of 25, 50 and 100 % (undiluted extract).
The animals did not show any clinical signs during the course of the study and no cases of mortality observed. After the last application of the test item extract a slight reddening of the ears of treated animals was observed. This observation was, however, not relevant, since the reddening was not severe.
In this study Stimulation Indices (S.I.) of 2.5, 2.3 and 2.3 were determined with the test item extract concentrations of 25, 50 and 100 %, respectively.
The extract of the test item Licowax E FL was not a skin sensitiser in this assay.
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