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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. 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 irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Justification for read-across, see attached file.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0,5 ml of test substance
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Time point:
- other: 1h
- Score:
- 0
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mean Scores.:
Erythema / Eschar: 0,0 for all 3 animals
Oedema: 0,0 for all 3 animals - Executive summary:
Aim of the study
The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits.
Methods
Methods and investigations were performed in accordance with the OECD Guideline 404 and the Directive 2004/73/EC, method B.4.
Administration of the test substance
0.5 mL "CRUDE TALL OIL" was applied via a patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 New Zealand White rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours.
First the test substance was administered to one animal. As no serious skin reactions were noted in this animal, the remaining two animals were exposed to the test substance one week later.
Investigations
• Body weights: at the start and at the termination of the test.
• General signs of toxicity: once daily.
• Skin examinations: 1, 24, 48 and 72 h after patch removal (p.a.).
Results
General signs of toxicity
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Skin examinations
• Erythema/Eschar: Not affected.
• Oedema: Not affected.
Residual test substance was noted on the exposed skin areas, resp. on the growing hair, until 72 h p.a.
Conclusion
The following mean scores were calculated for each animal from the examinations 24 h, 48 h and 72 h p.a.:
Mean Scores.:
- Erythema / Eschar: 0,0 for all 3 animals
- Oedema: 0,0 for all 3 animals
According to Commission Directive 2001/59/EC "CRUDE TALL OIL" does not require classification for skin irritation
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG Kastengrund
- Age at study initiation: 3 -5 month
- Weight at study initiation: 2.8 - 2.9 kg
- Housing: single housing
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen; Altromin GmbH Lage/Lippe
- Water (e.g. ad libitum): Tab water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12h/12h - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h, test substance was removed by washing with warm tab water at the end of the exposure period
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, lukewarm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: eshar formation was still visible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 7 days
- Irritant / corrosive response data:
- Edema score was 0 at day 7 but raised to a grade 1 in one animal and grade 2 in another animal at day 14. Erythema and eshar formaton was still visible after 14 days. Because edema was gone at day 7 and returned afterwards it may concluded that scratching occurred. The over all assumption is that ethylhexanoic acid is only slightly irritating.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See justification for read across in the attached file
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Results from Tall oil
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Results from Tall oil
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 2-EHA
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 2-EHA
- Interpretation of results:
- GHS criteria not met
- Executive summary:
According to Commission Directive 2001/59/EC "CRUDE TALL OIL" does not require classification for skin irritation, however 2 -ethylhexanoic acid is slightly irritant to skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 September 2005 - 7 October 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Justification for read-across, see attached file.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 1, 24, 48 and 72 hours p.a
- Number of animals or in vitro replicates:
- 3 females
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- other: Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The mean irritation parameters are 0,0 in scoring for all parametres. However, the scoring for the first hour for all animals is 1 except for chemosis where one out of three had scoring 0,0. Redness in the Conjunctivae area were associated with discharge with moistening of the lids and hairs just adjacent to the lids.
No signs of irritation was seen after 1h. - Interpretation of results:
- GHS criteria not met
- Executive summary:
Aim of the study
The aim of this study was to investigate possible irritating or corrosive effects of the pure test substance following a single administration into a conjunctival sac of rabbits.
Methods
Methods and investigations were performed in accordance with the OECD-Guideline 405 and the Directive 2004/73/EC, method B.5.
Administration of the test substance
0.1 mL of "CRUDE TALL OIL" was instilled into the conjunctival sac of one eye of each of 3 New Zealand White rabbits. Firstly the test substance was administered to one animal. As there was no corrosive or severe irritant effect observed, the test substance was administered to two additional animals one week later.
Investigations
• Body weights: at the start and at the termination of the test.
• General signs of toxicity: once daily.
• Eye examinations: 1, 24, 48 and 72 h after the administration (p.a.) of the test substance.
Results
General signs of toxicity
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Eye examinations
- Corneae and Irises: Not affected.
- Conjunctivae, redness: Some injected blood vessels (score "1") were observed in all animals only 1 h p.a.
- Conjunctivae, chemosis: Very slight swelling (score "1") was observed in 2/3 animals only 1 h p.a.
- Additional findings: Ocular discharge was noted in all animals 1 h p.a.
Conclusion
The mean scores were calculated for each animal was 0,0 from the examinations 24 h, 48 h and 72 h p.a.
- Endpoint:
- eye irritation: in vivo
- 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 for read across.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Tall oil
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Tall oil
- Irritation parameter:
- other: Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Tall oil
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Tall oil
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: 2-EHA
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 2-EHA
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 2-EHA
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 2-EHA
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The conclusions from read-across shows that the UVCB substance will not be classified according to CLP.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline conforme GLP Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG Kastengrund
- Age at study initiation: 3 - 5 month
- Weight at study initiation: 3.0 - 3.6 kg
- Housing: single housing
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen; Altromin GmbH Lage/Lippe
- Water (e.g. ad libitum): Tab water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12h/12h - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 µL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no
SCORING SYSTEM:
Draize
TOOL USED TO ASSESS SCORE:
fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 -72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Based on the available information, the substance was not observed to be irritating in eyes or skin in animal models. There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.
Justification for selection of skin irritation / corrosion endpoint: OECD & EC guideline study, no deviations, GLP
Justification for selection of eye irritation endpoint: OECD & EC guideline study, no deviations, GLP
Justification for classification or non-classification
According to the study results on crude tall oil and2 -ethylhexanoic acid the substance requires no clasification, because the results are not sufficient for classification.
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