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EC number: 268-859-6 | CAS number: 68152-93-2
- 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:
- Study Initiation: October 8, 2013; Treatment Start: October 15, 2013; Experimental Completion: November 18, 2013; Study Completion: November 20, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Tall oil, maleated
- EC Number:
- 268-859-6
- EC Name:
- Tall oil, maleated
- Cas Number:
- 68152-93-2
- Molecular formula:
- UVCB
- IUPAC Name:
- 3,7-dimethyl-14,16-dioxo-19-(propan-2-yl)-15-oxapentacyclo[10.5.2.0²,¹¹.0³,⁸.0¹³,¹⁷]nonadeca-13(17),18-diene-7-carboxylic acid; 8-(7-hexyl-1,3-dioxo-1,3,3a,4,7,7a-hexahydro-2-benzofuran-4-yl)octanoic acid
- Test material form:
- liquid
- Details on test material:
- Lot No.: HD0258QH13
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test Animal Rattus norvegicus
Strain: CD® [Crl:CD®(SD)BR] Sprague-Dawley
Source: Charles River Canada, Montreal, Quebec
Number and Sex: 5 female rats were used.
Body Weight: Range 200.2 - 216.7 g after fasting. The weight variation in animals at the start of the study did not exceed ±20 percent of the mean weight.
Acclimatization Period: 7 days
Age at Study Start: Approximately 7 to 8 weeks
Animal Identification: Body colour coding, cage labels
Animal Housing and Maintenance: Female rats were individually housed in separate quarters 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: temperature 19 °C to 25 °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 and study periods, except as specified under “Preparation of Animals”.
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 the Care and Use of Laboratory Animals, CCAC Guidelines for Care and Use of Experimental Animals and Nucro-Technics’ Standard Operating Procedures.
Animal Selection: The test population of animals was randomly selected from newly arrived, previously unused rats.
Preparation of Animals: All animals used for the Limit Test were fasted over-night. Food but not water was withheld beginning at 4:00 p.m. on the day preceding dosing, and was returned to the cages approximately 1 hour after dosing.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- The first animal was dosed at 2000 mg/kg. Since this animal survived, four additional animals were sequentially dosed at 2-day intervals. A total of five animals were dosed.
The test animals were dosed at 2000 mg/kg (2.0 mL/kg by volume of test item). - No. of animals per sex per dose:
- The individual doses of the test item were individually calculated for each animal based on the body weight of the animal. All doses were administered orally using a feeding cannula inserted into the stomach of the animals.
- Control animals:
- no
- Details on study design:
- Method
The method used for conducting this study is the accepted standard described in the Organisation for Economic Co-operation and Development (OECD) Guideline for the Testing of Chemicals, Acute Oral Toxicity (Up-and-Down Procedure), Section 425, (OECD, 2008). The study was conducted in accordance with Nucro-Technics Study Plan No. CAN/275630, Appendix I.
Justification for Selection of Test System: The test system is internationally accepted for use in acute oral toxicity studies.
Test System:
Test Animal Rattus norvegicus
Strain CD® [Crl:CD®(SD)BR] Sprague-Dawley
Source Charles River Canada, Montreal, Quebec
Number and Sex 5 female rats were used.
Body Weight Range 200.2 - 216.7 g after fasting. The weight
variation in animals at the start of the study
did not exceed ± 20 percent of the mean
weight.
Acclimatization Period 7 days
Age at Study Start Approximately 7 to 8 weeks
Animal Identification Body colour coding, cage labels
Animal Housing and Maintenance
Female rats were individually housed in separate quarters 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: temperature 19 °C to 25 °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 and study periods, except as specified under “Preparation of Animals”. 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 the Care and Use of Laboratory Animals, CCAC Guidelines for Care and Use of Experimental Animals and Nucro-Technics’ Standard Operating Procedures.
Animal Selection
The test population of animals was randomly selected from newly arrived, previously unused rats.
Preparation of Animals
All animals used for the Limit Test were fasted over-night. Food but not water was withheld beginning at 4:00 p.m. on the day preceding dosing, and was returned to the cages approximately 1 hour after dosing.
Experimental Procedures
Limit Test
The first animal was dosed at 2000 mg/kg. Since this animal survived, four additional animals were sequentially dosed at 2-day intervals. A total of five animals were dosed.
Dose Administration
The test animals were dosed at 2000 mg/kg (2.0 mL/kg by volume of test item). The individual doses of the test item were individually calculated for each animal based on the body weight of the animal. All doses were administered orally using a feeding cannula inserted into the stomach of the animals.
Observations During In-Life Phase
The animals were individually observed once during the first 30 minutes after dosing and periodically during the first 24 hours following dosing (with special attention given during the first 4 hours). Observations once daily were carried out for the remainder of the study. The animals were observed for 14 days after the dosing. Cageside observations were directed towards any changes in the skin and fur; eyes and mucous membranes; respiratory, circulatory, autonomic and central nervous system; and also somatomotor activity and behaviour pattern. Particular attention was directed to any observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and/ or coma. All observations were recorded daily for the entire study period using the In-Life Module V.6.1, and the entries were monitored by the Study Director. The body weights of the animals were determined prior to test item administration (i.e., Day 0), on Day 7 and on Day 14. Body weight gains were calculated. For calculation of LD50, results were entered into the Acute Oral Toxicity statistical program, V.1.0.
Post Mortem Examination
Gross necropsy was performed on each rat at the end of a 14-day observation period and necropsy included an 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.
Archive
The original copy of the protocol, and all raw data that were generated at Nucro-Technics and a copy of the final report will be stored in the Nucro-Technics’ archives for 6 years. Nucro-Technics will notify the Sponsor in advance of the end of this period to allow the Sponsor to secure alternative storage facilities, if required. - Statistics:
- For calculation of LD50, results were entered into the Acute Oral Toxicity statistical program, V.1.0.
Results and discussion
- Preliminary study:
- The first animal was dosed at 2000 mg/kg. Since this animal survived, four additional animals were sequentially dosed at 2-day intervals. A total of five animals were dosed.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed post dosing and during the 14-day observation period in any of the animals.
- Clinical signs:
- other: All clinical signs appear normal
- Gross pathology:
- No organs with gross findings were observed in necroscopy observations
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the foregoing results, the acute oral LD50 in rats of the test item, Tall Oil, Maleated (EnvaMul™ 600) was found to be greater than 2000 mg/kg. Therefore, the test item is considered not to present a significant acute toxic risk if swallowed.
- Executive summary:
An Acute Oral Toxicity Study of the test item, Tall Oil, Maleated (EnvaMul™ 600), was carried out at Nucro-Technics according to Study Plan No. CAN/275630. The first animal was dosed at 2000 mg/kg, 2.0 mL/kg by dose volume. Since this first animal survived, four additional test animals were dosed at 2-day intervals. A total of 5 female CD (Sprague-Dawley) rats were dosed. All animals received the test item by oral gavage using a feeding cannula inserted into the stomach of the animals. The animals were observed for a 14-day period after dosing. Body weights were recorded prior to test item administration (i.e., Day 0), on Day 7 and prior to necropsy on Day 14. No mortalities were observed post dosing and during the 14-day observation period in any of the animals. All rats gained body weight by Day 7 and again by Day 14. At the end of a 14-day observation period, each animal was sacrificed and submitted for gross necropsy. No gross pathological findings were observed in any of the rats at necropsy. Based on the foregoing results, the acute oral LD50 in rats of the test item, Tall Oil, Maleated (EnvaMul™ 600), was found to be greater than 2000 mg/kg. Therefore, the test item is considered not to present a significant acute toxic risk if swallowed.
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