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EC number: 266-037-1 | CAS number: 65997-01-5
- 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:
- 13.09.05 to 16.11.05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Tall oil
- EC Number:
- 232-304-6
- EC Name:
- Tall oil
- Cas Number:
- 8002-26-4
- IUPAC Name:
- Crude Tall Oil
- Test material form:
- liquid
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
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 16.4-21.6 g
- Housing: Individually in Makrolon Type II cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (average)
- Humidity (%): 64.8 (average)
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14.09.05 To: 19.09.05
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 and 50 % (v/v) equivalent to doses of 15, 37.5 and 75 mg, respectively.
- No. of animals per dose:
- Five
- Details on study design:
- RANGE FINDING TESTS:
- Compound concentration: 100 and 50%
- Irritation: No local skin irritation with either dose. There was a slight increase in ear thickness at the highest dose, but not at the lower dose.
- Lymph node proliferation response: Not measured.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: if the test substance induces a three-fold or greater increase in 3HTdR incorporation into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes, as indicated by the stimulation index, together with the consideration of dose response.
TREATMENT PREPARATION AND ADMINISTRATION: The test substance (25 µl/ear) was administered in three concentrations to the dorsal surfaces of the ears of the animals of the test substance groups. In a manner identical to that of animals in the treatment groups animals of one negative control group and one positive control group were treated with acetone/olive oil and hexyl cinnamic aldehyde, respectively. Each animal was treated for three consecutive days. Three days after the last administration the proliferation of the lymphocytes of the draining lymph nodes was measured by the determination of the amounts of incorporated 3HTdR (20 µCi of 3HTdR administered to mice via the tail vein).
Approximately 5 hours after 3HTdR injection all animals were sacrificed by carbon dioxide asphyxiation and the draining auricular lymph nodes were rapidly excised. The lymph nodes of each group were pooled in PBS. A single cell suspension (SCS) of lymph node cells (LNC) was prepared by gentle mechanical disaggregation of the pooled lymph nodes. The SCSs were then transferred into centrifuge tubes and LNC were pelleted by centrifugation. Afterwards supernatants were removed by aspiration. Then the LNC were resuspended and washed twice with PBS. After the final washing the supernatants were removed leaving just a small volume (<0.5 mL) and macromolecules were precipitated by incubation with 5 % trichloroacetic acid (TCA) at 4°C overnight. Each precipitate was pelleted by centrifugation and resuspended in 1 mL TCA. This suspension was transferred into scintillation vials containing 10 mL scintillation cocktail and 3HTdR incorporation was determined with a β-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No data
Results and discussion
- Positive control results:
- Application of 25% HCA in AOO resulted in an SI of 5.3. This result proves the sensitivity of the strain of animals used and the reliability of the experimental technique.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- low dose group
- Key result
- Parameter:
- SI
- Value:
- 2.6
- Test group / Remarks:
- medium dose group
- Key result
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- high dose group
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- negative control group
- Key result
- Parameter:
- SI
- Value:
- 5.3
- Test group / Remarks:
- positive control group
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Low, medium and high dose: 4338, 13098 and 19314. Negative control: 4955 Positive control: 26402
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- In a good quality Local Lymph Node Assay (reliability score 1) conducted according to OECD test guideline 429, and GLP, Crude Tall Oil (CAS 8002-26-4) was regarded as a skin sensitiser. It is considered valid to read across this result to the related substance Tall Oil Soap.
- Executive summary:
Crude Tall Oil was diluted with acetone: olive oil (AOO), 4:1, v/v (10, 25 and 50% solutions) and was administered to three groups of five female CBA/Ca mice. Administration was performed epicutaneously to the dorsal surface of both ears, once per day on three consecutive days. The volume administered was 25 µl per ear. Positive (hexyl cinnamic aldehyde: HCA 25% in AOO) and negative (AOO) control substances were administered under identical conditions as the test substance. Five days after the first topical application, 3H-thymidine was intravenously administered to all mice via a tail vein. Approximately five hours later all animals were sacrificed, the draining auricular lymph nodes were excised, pooled for each group, and single cell suspensions were prepared. Then incorporation of 3H-methyl thymidine into the cells was determined and compared with the negative controls. The stimulation index (SI) was calculated as the ratio of the disintegrations per minute (DPM) of the dosed groups or of the positive control group to the DPM of the negative control group.
All animals survived until the end of the study, and no adverse effects were observed in any of the animals. Body mass gains were within the normal range for the strain, sex and age of the mice used. No skin irritating effects were observed in any of the groups. The SIs of the test substance were 0.9, 2.6 and 3.9 for the low, medium and high dose groups, respectively. The positive control group gave a SI of 5.3, thus demonstrating the validity of the test. According to the OECD test guideline a positive result should be regarded if the SI is equal to or greater than 3, together with consideration of the dose-response. Therefore it was concluded by the authors that Crude Tall Oil is sensitising to the skin.
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