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EC number: 941-532-1 | 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
Endpoint summary
Administrative data
Description of key information
The study was performed to determine the acute oral toxicity of the test item Tall Oil Pitch, reaction product with triethylene glycol in the female Wistar rat. The study was performed according to the OECD Guideline 420 and under GLP conditions.
A single dose of 2000 mg/kg bw was administered to female Wistar rat via oral gavage. Clinical signed and body weight changes were monitored during the study. All animals were subjected to gross necropsy. There were no deaths during the length of the study. No signs of systemic toxicity were observed. The body weight were in the normal values. No abnormalities were recorded in the necropsy.
In conclusion, according to the results of this study, the acute oral median lethal dose (LD50) of the test item was found to be greater than 2000 mg/kg/bw, therefore the substance is unclassified.
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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Identification: Tall Oil Pitch, reaction product with triethylene glycol
CAS Number: 2135769-54-7
CAS Nme: Tall oil pitch, ester with triethylene glycol
Batch: LABO 16-02
Purity: 100%
Physical state: brown viscous liquid
Expiry date: 14/11/2018
Storage conditions: room temperature in the dark under nitrogen - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Allocation on receipt: random
- Acclimatation: 5 days
- Age: 8-12 weeks
- Body weight variation: not more that +/-20%
- Housing: groups of up to four in suspended solid - floor polypropylene cages furnished with woodflakes.
- Diet: free access
- Water: free acess
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15 per hr
- Photoperiod (hrs dark / hrs light): 12 light / 12 dark
- Route of administration:
- oral: gavage
- Details on study design:
- Starting dose: 2000 mg/kg/bw
A single animal was treated as follows:
- Dose level: 2000 mg/kg/bw
- Concentration: 200 mg/mL
- Dose Volume: mL/kg
- Number of rat / female: 1
In the absence toxicity at a dose level of 2000 mg/kg, an additional group of animal was treated as follows:
- Dose level: 2000 mg/kg/bw
- Concentration: 200 mg/mL
- Dose Volume: mL/kg
- Number of rat / female: 4
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
All animals were dosed once by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential.
Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.
Clinical observations were made 30 minutes, 1, 2 and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Mortality:
- There were no deaths
- Clinical signs:
- other: No signs of systemic toxicity were noted
- Gross pathology:
- No abnormalities were noted
- Other findings:
- No abnormalities were noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the femal Wistar strain rats was determied to be greated than 2000 mg/bw bw.
- Executive summary:
The study was performed to determine the acute oral toxicity of the test item Tall Oil Pitch, reaction product with triethylene glycol in the female Wistar rat. The study was performed according to the OECD Guideline 420 and under GLP conditions.
A single dose of 2000 mg/kg bw was administered to female Wistar rat via oral gavage. Clinical signed and body weight changes were monitored during the study. All animals were subjected to gross necropsy. There were no deaths during the length of the study. No signs of systemic toxicity were observed. The body weight were in the normal values. No abnormalities were recorded in the necropsy.
In conclusion, according to the results of this study, the acute oral median lethal dose (LD50) of the test item was found to be greater than 2000 mg/kg/bw, therefore the substance is unclassified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Key study - K1 - GLP - Accoring to OECD TG 430
Additional information
Justification for classification or non-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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