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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
Endpoint summary
Administrative data
Description of key information
The hazard information on the substance is based on read across from Tall oil and 2-ethylhexanoic acid and reveals low toxicity, however may irritate the skin. Furthermore, the source substances contain higher or similar concentrations of the constituents used for read across compared to the target substance. There are no scientific reasons indicating that the constituents of the substance can interact in a way that will influence the toxicological/ecotoxicological properties of the substance.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
- 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)
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- No. of animals per dose:
- 5
- 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)
- Positive control results:
- The positive control substance led to a stimulation index of 5.3.
- 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
- 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".
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP; non guideline; minor restrictions in design but adequate for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- GPMT test already available since 1979
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- No. of animals per dose:
- treated group: 10
control group: 5 - Details on study design:
- RANGE FINDING TESTS: 2 guinea pigs which were pre-treated with adjuvant only at the induction phase, test substance was applied at concentrations of 10, 5, 2 and 1%. A concentration of 2% was selected as the level to be used at the challenge stage.
MAIN STUDY
A. INDUCTION EXPOSURE
treated group: 3 injections: a) 0.1 ml Freund's adjuvant alone; b) 0.1 ml 2-ethylhexoic acid (1% w/w) alone; c) 0.05 ml 2-ethylhexoic acid (1% w/w) emulsified with 0.05 ml Freund's adjuvant; 6 days after the injection phase: treatment with sodium lauryl sulphate solution (10 % w/w), after 24 h: patch of Whatman No. 3 MM filter paper saturated with 2-ethylhexoic acid (5% w/w) covered by an overlapping patch of impermeable plastlc adhesive tape for48 h
control group: injection with Freund's adjuvant alone
B. CHALLENGE EXPOSURE
treated and control group: two weeks after the topical induction: 2-ethylhexoic acid (2% w/w) was applied on a 2 x 2 cm piece of filter paper to the test site of the guinea pig. The patch was held in place for the topical induction and removed 24 h Iater.
The degree of response was determined by trained assessors 24 h after removal of the challenge patch. Positive response are rated
according to the percentage of animals sensitised (Kligman). - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2% w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no data.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions tested, the test substance is a non-sensitiser in guinea pigs.
- Endpoint:
- skin sensitisation, other
- Remarks:
- LLNA and non-LLNA
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See attached file for justification of read across
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: 2-EHA
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no data
- Remarks on result:
- other: 2-EHA
- Key result
- Parameter:
- SI
- Variability:
- 0.9-3.9
- Remarks on result:
- other: tall oil
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no reason to believe that results obtained in the studies would not be applicable to humans.
Justification for selection of skin sensitisation endpoint: OECD & EC guideline study, no deviations, GLP
Justification for classification or non-classification
"Crude Tall Oil" is regarded as a sensitiser in the LLNA according to the OECD-Guideline 429 and the Directive 2004/73/EC, method B.42., "Skin Sensitisation: Local Lymph Node Assay", since the SIs of one examined test substance concentrations was greater than 3. 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 "H317 May cause sensitisation by skin contact". Because of the classification of crude tall oil, the substance is classified as skin sensitising category 1 and needs to be labelled with "H317 May cause sensitisation by skin contact". The available data is not sufficient for sub classification into skin sensitising 1A or 1B. However, 2-ethylhexanoic acid is not regarded a sensitizer in the non-LLNA test.
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