Registration Dossier
Registration Dossier
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: 938-639-0 | CAS number: -
- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-10-2013 - 18-11-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to the guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Tall Oil, Polymd, Oxidised (Envamul 200)
- IUPAC Name:
- Tall Oil, Polymd, Oxidised (Envamul 200)
- Test material form:
- liquid: viscous
- Details on test material:
- The CAS name quoted above together with the pertinent CAS number (68815-17-8) has been used to identify this substance. This CAS number is listed on some inventories as :-
“Tall oil, polymd, oxidized” (TSCA, USA)
“Tall oil, polymerized, oxidized” (AICS, Australia)
“Tall oil, polymd, oxidized” (ENC, Japan)
“Tall oil, polymd, oxidized” (KECI, Korea)
“Tall oil, polymd, oxidized” (DSL, Canada)
However, GPC analysis has confirmed that this substance, Oxidised Crude Tall Oil is not a polymer as this CAS name implies. Elsewhere in this dossier the term "Oxidised Crude Tall Oil" has been used to describe this substance which is believed to be a better description of this substance.
Thus, the name "Tall oil, polymd, oxidized" has, historically, been used to describe this substance in error.
- Substance type: UVCB
- Physical state: Dark brown, viscous liquid
- Analytical purity: 100%
- Lot/batch No.: HPQD09T060
- Storage condition of test material: Stored in tightly closed original container in a dry and well-ventilated place at room temperature. Kept in original container.
- Supplier: MeadWestvaco Corporation
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female rats, obtained from Charles River Canada, Montreal, Quebec (body weight range 200.2 - 208.0 g [after fasting]) were individually housed in solid bottom cages. Individual animals were identified by colour coding; the animal number and group number also appeared on the outside of each cage to preclude mix-up. The animal room environment was controlled (targeted ranges : temperatures 19 - 25 degrees C, relative humidity 30 - 70%, minimum 10 air changes per hour) and monitored. The photo-cycle was 12 hours light and 12 hours dark. Upon arrival all animals were submitted to a general physical examination and all were found healthy and were admitted. Teklad Certified Rodent Diet and water were offered ad libitum throughout the acclimatization (7 days).
The cage cleaning schedule, air filtration and recirculation, health checks and facility maintenance were carried out in accordance with the applicable Nucro-Technics' Standard Operating Procedures, and such activities were recorded in the animal room records.
Animals were housed and maintained according to the AAALAC International Guide for Care and Use of Laboratory Animals (https://www.aaalac.org/about/guidelines.cfm), CCAC Guidelines for Care and Use of Experimental Animals (http://www.ccac.ca/en_/standards/guidelines) and Nucro-Technics Standard Operating Procedures.
All animals used for the Limit test were fasted overnight. Food, but not water, was withheld beginning at 4.00 pm on the day preceding dosing, and was returned to the cages approximately 1 hour after dosing.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.0 mL/kg bw
Schedule: Since this animal survived, four additional animals were sequentially dosed at 2-day intervals. A total of 5 animals were dosed. - Doses:
- 2000 mg/kg (limit test)
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individally once during the first 30 minutes of dosing, periodically during the first 24 hours following dosing. Observations were subsequently carried out once daily for the remainder of the study. Cageside observations focused upon any changes in the skin and fur; eyes and mucous membranes; respiratory, circulatory, autonomic and central nervous system and also somatomotor and behavior patterns. Special attention was given to any observation of tremours, convusions, salivation, diarrhoea, lethargy sleep and/or coma.
The body weights were determined prior to test item administration (Day 0), on Day 7 and on Day 14. Body weights gains were calculated.
- Necropsy of survivors performed: yes
This included examination of:
External surfaces of the body, All orifices, Cranial cavity, External surfaces of the brain and spinal cord, Nasal cavity and paranasal sinuses, Thoracic, abdominal and pelvic cavities and viscera.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No pathalogical findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 after oral administration of the test substance is > 2000 mg/kg.
- Executive summary:
Female rats (n=5) received a single oral dose of 2000 mg/kg bw of the test substance. No effects on clinical signs, body weight and macroscopic examinations were observed. Since no mortalities were observed the LD50 was found to be> 2000 mg/kg bw.
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.
