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EC number: 263-009-0 | CAS number: 61788-81-6
- 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
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 August 2005 - 7 September 2005
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Methods and investigations were performed in conformance with the OECD-Guideline 423, 17 December 2001 and the Directive 2004/73/EC, method B.1 tris.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- other: Crl:CD(SD)IGS BR.
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- 300 (mg/kg b.w.) and 2000 (mg/kg b.w.)
- No. of animals per sex per dose:
- 3 per step (6 per dose)
- Control animals:
- no
- Preliminary study:
- As no prior information on the toxicity of the test substance was available, a starting dose of 300 mg of the test substance per kg body weight was chosen.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to Commission Directive 2001/59/EC "CRUDE TALL OIL" does not require classification for acute oral toxicity.
- Executive summary:
Aim of the study
The aim of the study was to investigate acute toxic effects of the test substance after a single peroral administration to rats.
Methods
Methods and investigations were performed in conformance with the OECD-Guideline 423, 17 December 2001 and the Directive 2004/73/EC, method B.1 tris.
Administration of the test substance
"CRUDE TALL OIL" was administered once as a solution in corn oil, given orally via gavage to female Crl:CD(SD)IGS BR rats.
The dosing was performed sequentially to groups of 3 animals per step using a starting dose of 300 mg per kg body weight and 2000 mg per kg body weight as the second dose.
The dose volume was 10 mL per kg body weight for all groups.
Investigations
• Body weights: before administration, 7 and 14 days after the administration (p.a.).
• Clinical observations: at least once per day.
• Necropsy: The animals were sacrificed and necropsied 14 days p.a.
Results
According to Commission Directive 2001/59/EC "CRUDE TALL OIL" does not require classification for acute oral toxicity.
- Endpoint:
- acute toxicity: oral
- 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
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 640 mg/kg bw
- Based on:
- test mat.
- Executive summary:
The conclusions from read-across shows that the UVCB substance will not be classified according to CLP.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- other: US-rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 228 ± 22 (male), 161 ± 18 (female)
ENVIRONMENTAL CONDITIONS
not reported - Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous emulsion containing 0.5 %Traganth
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2; 20; 30 %
- Amount of vehicle (if gavage): 1.2 - 3.4 ml depending on the body weight and dose group
MAXIMUM DOSE VOLUME APPLIED: 3,4 ml - Doses:
- 4.0, 3.2, 1.6 0.2 ml/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was only at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the except on weekends and on Holydays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 640 mg/kg bw
- Mortality:
- 4.0 mL/kg: 0/10 died within 24 hrs; 5/10 animals died within 48 hrs; no additional death until study termination at day 7
3.2 mL/kg: 2/10 animals died within 24 hrs, 1 additional animal died after 48 hours; , no additional death until study termination at day 7
1.6 mL/kg: 1/10 animal died after 24 hrs, no additional death until study termination at day 7
0.2 mL: 0/10 wit in 7 days
4ml/kg of pure substance is equal to 3640 mg/kg bw (density 0.91 g/mL) - Clinical signs:
- 3.2 and 4 mL/kg: apathy, dyspnea, abdominal position,red crusted eyes and snouts. free of clinical signs by day 5
0.2 and 1.6 mL/kg: accelerated breathing; high steppy gait, ruffled fur. free of clinical signs by day 2 - Body weight:
- not recorded
- Gross pathology:
- No substance related findings were noted.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Studies have been carried out according GLP and the recommended OECD guideline
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 August 2005 - 25 August 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD-Guideline 402, 1987
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other:
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- other: A cellulose patch with the individually weighed amount of the test substance on the surfac
- Duration of exposure:
- 24h
- Doses:
- The dose was 2000 mg per kg body weight.
- No. of animals per sex per dose:
- 5 male and 5 female/dose
- Key result
- Sex:
- male/female
- Dose descriptor:
- other: LD50 dermal
- Effect level:
- > 2 000 mg/kg bw
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No local or systemic toxic effects related to administration of the test substance were noted from clinical observations or post-mortem-examination at a dose of 2000 mg of the test substance per kg body weight.
No mortality occurred.
No classification of "CRUDE TALL OIL" is therefore derived from the results of this study according to the Directive 93/21/EEC. - Executive summary:
Aim of the study
The aim of the study was to investigate acute toxic effects of the test substance after a single dermal administration to rats.
Methods
Methods and investigations were performed in conformance with the OECD-Guideline 402, 1987 and the Directive 92/69/EEC, annex B.3.
Administration of the test substance
"CRUDE TALL OIL", was administered once dermally on an area of approximately 6.5 cm x 8 cm on the dorsal thoracal region of 5 male and 5 female Sprague Dawley rats. The dose was 2000 mg per kg body weight.
A cellulose patch with the individually weighed amount of the test substance on the surface, was applied to the test site and held in place by fixing marginally with non irritating tape.
Patch and tape were covered semi-occlusively by a dressing.
The duration of the exposure was 24 hours.
Investigations
• Body weights: before the administration, 7 and 14 days after the administration (p.a.).
• Clinical observations: at least once per day.
• Necropsy: 14 days p.a.
Results
presence of clinical signs:
- no signs
full recovery of the survivors:
- not applicable
body weights:
- inconspicuous in all males 0 - 14 d p.a.
- body weight loss in one female 0 - 7 d p.a.
- inconspicuous in all females 7 - 14 p.a. sex differences no
findings in life and post-mortem indicate:
- no toxic effects present
LD50, dermal > 2000 mg /kg body weight
Conclusion
No local or systemic toxic effects related to administration of the test substance were noted from clinical observations or post-mortem-examination at a dose of 2000 mg of the test substance per kg body weight.
No mortality occurred.
No classification of "CRUDE TALL OIL" is therefore derived from the results of this study according to the Directive 93/21/EEC.
- Endpoint:
- acute toxicity: dermal
- 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 read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: tall oil
- Key result
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 2-EHA
- Executive summary:
The conclusions from read-across shows that the UVCB substance will not be classified according to CLP.
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF
- Age at study initiation: 7 weeks (males) 9 weeks (females
- Weight at study initiation: 208 +/- 4 g (males); 191 +/- 3 g (females
- Fasting period before study: no
- Housing: single in macrolone cages (Type 3) on wooden bedding
- Diet (e.g. ad libitum): ad libitum Altromin 1234 (Altromin GmbH, Lage/Lippe)
- Water (e.g. ad libitum): tab water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 8 cm
- % coverage:
- Type of wrap if used: alu folie, fixed by tape (Fixomull; Elastoplast; Fa. Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 ml pure substance (desity 0.9 g/ml) - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation : daily; weighing prior to application on day 7 and day 17 (Study termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not necessary
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- no clinical symptoms besides eshar formation in two females from day 5-day 8
- Body weight:
- Body weight development was positive
- Gross pathology:
- no substance related macroscopic findings
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Studies have been carried out according GLP and the recommended OECD guideline
Additional information
Based on the available information, the acute toxicity of the Substance is low for two routes of administration. Even though there is no information on acute toxicity in humans, there is no reason to believe that the low acute toxicity observed in experimental animals would not be relevant for human health.
Justification for selection of acute toxicity – oral endpoint: OECD & EC guideline study, no deviations, GLP
Justification for selection of acute toxicity – dermal endpoint: OECD & EC guideline study, GLP
Justification for classification or non-classification
According to the study results on crude tall oil and 2 -ethylhexanoic acid the substance requires no clasification, because the results are not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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