Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 June 2001 - 26 September 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Justification for read-across, see attached file.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: Testing and evaluation of clastogenic potential - chromosomal aberrations assays.
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
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- The cell line used was Chinese hamster ovary (CHO) cells, obtained from the University of Leiden in 1987.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced S9 enzymes (supernatant post-mitochondrial fraction obtained after centrifugation at 9000 G) were prepared from the livers of adult, male Fischer rats, as described by Ames et al (1975).
- Test concentrations with justification for top dose:
- For the first experiment, 9 dose levels, covering a wide concentration range, were tested. The highest dose was 5000 µg.ml-1, the maximum allowable concentration and subsequent dose levels were halving dilutions.
The presence of S9 mix had to be repeated due to toxicity and the following concentrations were tested:
in Test 1: 10, 20, 40, 60 and 80 µg.ml-1
In Test 2, the dose levels selected were:
Presence of S9 mix: 5, 10, 20, 30, 40, 50 and 60 µg.ml-1
Absence of S9 mix: 50, 55, 60, 62.5, 65, 67.5 and 70 µg.ml-1 - Vehicle / solvent:
- Dimethylsulphoxide
Controls
- Untreated negative controls:
- other: Historically negative control data
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- other: weakly clastogenic
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: Historical negative control
- Positive controls validity:
- valid
- Additional information on results:
- Tall Oil, CAS No. 8002-26-4, was toxic to Chinese hamster ovary cells in vitro in both the presence and absence of S9 mix. It was tested to the maximum permitted concentration of 5000 µg.ml-1 in the absence of S9 mix and up to 80 µg.ml-1 in the presence of S9 mix (Test 1). Toxicity was noted at 60 and 80 µg.ml-1 in the presence of S9 mix and at 156-5000 µg.ml-1 in the absence of S9 mix. In Test 2, Tall Oil, CAS No. 8002-26-4, was tested up to 60 µg.ml-1 in the presence of S9 mix and up to 70 µg.ml-1 in the absence of S9 mix. Toxicity was noted in cultures treated with 30-60 µg.ml-1 (presence of S9 mix) and in cultures treated with 70 µg.ml-1 (absence of S9 mix).
It was concluded that Tall Oil, CAS No. 8002-26-4, was weakly clastogenic when tested with Chinese hamster ovary cell in vitro in the presence of S9 mix. The response was observed only at a concentration level deemed overtly toxic to the cells.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that Tall Oil, CAS No. 8002-26-4, was weakly clastogenic when tested with Chinese hamster ovary cell in vitro in the presence of S9 mix. The response was observed only at a concentration level deemed overtly toxic to the cells.
- Executive summary:
Aim:
Tall Oil, CAS No. 8002-26-4, was submitted for testing and evaluation of clastogenic potential.
Method:
Chromosomal aberrations assays were performed with duplicate, Chinese hamster ovary (CHO) cell cultures. This study was conducted incorporating two independent tests. Dimethylsulphoxide was the vehicle and cyclophosphamide and methyl methanesulphonate were the positive controls used in both tests. Both tests were conducted in the presence and absence of a postmitochondrial supernatant fraction obtained from the livers of adult, male rats treated with Aroclor 1254 (S9) and a NADPH-generating system.
Cultures, established approximately 20 hours before testing, were treated for 6 h in the presence or 6 and 22 hours in the absence of S9 mix. Cultures were harvested at 24 h (Test 1 and 2) or 48 h (Test 2) post treatment.
Results/Conclusion
Tall Oil, CAS No. 8002-26-4, was toxic to Chinese hamster ovary cells in vitro in both the presence and absence of S9 mix. It was tested to the maximum permitted concentration of 5000 µg.ml-1 in the absence of S9 mix and up to 80 µg.ml-1 in the presence of S9 mix (Test 1). Toxicity was noted at 60 and 80 µg.ml-1 in the presence of S9 mix and at 156-5000 µg.ml-1 in the absence of S9 mix. In Test 2, Tall Oil, CAS No. 8002-26-4, was tested up to 60 µg.ml-1 in the presence of S9 mix and up to 70 µg.ml-1 in the absence of S9 mix. Toxicity was noted in cultures treated with 30-60 µg.ml-1 (presence of S9 mix) and in cultures treated with 70 µg.ml-1 (absence of S9 mix).
It was concluded that Tall Oil, CAS No. 8002-26-4, was weakly clastogenic when tested with Chinese hamster ovary cell in vitro in the presence of S9 mix. The response was observed only at a concentration level deemed overtly toxic to the cells.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.