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EC number: 266-942-1 | CAS number: 67701-23-9
- 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:
- 2005-09-13 - 2005-09-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Justification for read across, see attached document.
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)
- Version / remarks:
- 24 april 2002
- 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
- Molecular formula:
- Not applicable - UVCB substance
- Test material form:
- liquid: viscous
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 5
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- A (low dose) 10 % Crude Tall Oil (v/v) 15 mg
B (mid dose) 25 % Crude Tall Oil (v/v) 37.5 mg
C (high dose) 50 % Crude Tall Oil (v/v) 75 mg
K (negative control) AOO 150 mg
P (positive control) 25% HCA in AOO (v/v) 37.5 mg - No. of animals per dose:
- 5
- Details on study design:
- The test substance was administered in 3 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 AOO and HCA respectively. Each animal was treated for 3 consecutive days. 3 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.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control substance led to a stimulation index of 5.3.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- Low dose dpm 4338
- Key result
- Parameter:
- SI
- Value:
- 2.6
- Test group / Remarks:
- mid dose dpm 13098
- Key result
- Parameter:
- SI
- Value:
- 3.9
- Test group / Remarks:
- High dose dpm 19314
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- According to the OECD-Guideline 429 and the Directive 2004/73/EC, method B.42., "Skin Sensitisation: Local Lymph Node Assay", "Crude Tall Oil" is regarded as a sensitiser in the LLNA.
- Conclusions:
- 3H-thymidine incorporation, stimulation indices The calculated stimulation indices (test substance/negative control ratio) were decisive for the grading of the potential of sensitisation: According to the guidelines the decision process with regard to a positive response includes a stimulation index of equal to or greater than 3, together with consideration of dose-response.
A concentration related response was observed. The SIs of the tested test substance concentrations were 0.9 (low dose), 2.6 (mid dose) and 3.9 (high dose).
Positive control The positive control substance led to a stimulation index of 5.3, thus demonstrating the validity of the experiment. - Executive summary:
Aim
The Local Lymph Node Assay was performed to evaluate a possible skin sensitising potential of "Crude Tall Oil" according to the OECD-Guideline 429, 24 April 2002 and the EC Directive 2004/73/EC, method B.42., 30 April 2004.
Method
The test substance was diluted with Acetone:olive oil, 4:1, v/v (AOO) and was administered to three groups of 5 female CBA/Ca mice. Administration was performed epicutaneously to the dorsal surface of both ears, once a day on three consecutive days. The volume administered was 25 µL per ear.
Concentrations used:
• Group A (low dose): 10% (v/v) solution of "Crude Tall Oil" in AOO
• Group B (mid dose): 25% (v/v) solution of "Crude Tall Oil" in AOO
• Group C (high dose): 50% (v/v) solution of "Crude Tall Oil" in AOO
Two groups with 5 animals each served as positive and negative controls. Both control substances were administered under identical conditions as the test substances. The following solutions served as control substances:
• Group P (positive control): 25% (v/v) solution of hexyl cinnamic aldehyde in acetone:olive oil (4:1, v/v)
• Group K (negative control): AOO
5 days after the first topical application, 3H-thymidine was intravenously administered to all mice via a tail vein. Approximately 5 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 (liquid scintillation counter) 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.
Results
General All animals survived till the end of the study. No adverse effects were noted in any animal. Body masses and body mass gains were in the range to be expected from animals of the same strain, sex and age. No skin irritating effects were observed in the test substance groups and both control groups throughout the whole study.
3H-thymidine incorporation, stimulation indices The calculated stimulation indices (test substance/negative control ratio) were decisive for the grading of the potential of sensitisation: According to the guidelines the decision process with regard to a positive response includes a stimulation index of equal to or greater than 3, together with consideration of dose-response.
A concentration related response was observed. The SIs of the tested test substance concentrations were 0.9 (low dose), 2.6 (mid dose) and 3.9 (high dose).
Positive control The positive control substance led to a stimulation index of 5.3, thus demonstrating the validity of the experiment.
CONCLUSION
According to the OECD-Guideline 429 and the Directive 2004/73/EC, method B.42., "Skin Sensitisation: Local Lymph Node Assay", "Crude Tall Oil" is regarded as a sensitiser in the LLNA.
According to the results of this study and to the Directive 2001/59/EC for classification, the test substance "Crude Tall Oil" needs to be labelled with "R43 May cause sensitisation by skin contact".
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