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Diss Factsheets
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EC number: 946-615-6 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral: LD50 > 5000 mg/kg bw (OECD 420 in rats, K, rel.1)
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:
- 05 September to 05 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD Guideline 420 without deviation.
- Qualifier:
- according 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
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on July 05, 2016/ signed on October 28, 2016)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Specific details on test material used for the study:
- - Storage conditions: At room temperature, protected from moisture (Dry area, unopened containers, optimum temp. 11-25 °C / 52-77 °F)
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan™:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Ltd.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: ca. 8-12 weeks
- Weight at study initiation: 150-164 g.
- Fasting period before study: overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing.
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Animal room: The rate of air exchange was at least fifteen changes per hour. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Photoperiod: 12 h dark / 12 h light - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Arachis oil BP was used after a solubility trial.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test substance was formulated at concentrations of 30 and 200 mg/mL in the vehicle.
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 female at 300 mg/kg bw
5 females at 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations:
Mortality: Cages of rats were checked at least twice daily for any mortalities.
Clinical signs: Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days.
- Frequency of weighing: Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: 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. - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- No signs of systemic toxicity were noted during the observation period for any animals receiving 300 or 2000 mg/kg bw.
- Body weight:
- All animals showed expected gains in body weight over the observation period.
- Gross pathology:
- All animals were killed at Day 14. No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of the test substance in female Wistar strain rat is estimated to be greater than 2000 mg/kg bw.
Under the test conditions, and according to the OECD TG 420 criteria, the LD50 cut-off value is considered to be greater than 5000 mg/kg bw, therefore it is not classified according to Regulation EC No. 1272/2008 (CLP) and to the GHS. - Executive summary:
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, following a sighting test at dose levels of 300 mg/kg body weight and 2000 mg/kg body weight, a further group of four fasted females Wistar rats was given a single oral dose of test item, as a solution in DMSO, at a dose level of 2000 mg/kg body weight. Animals were then observed for mortality, clinical signs and body weights for 14 days and were all sacrificed for macroscopic examination.
There were no deaths and no clinical signs during the study. All animals showed expected gains in body weight. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 14.
Oral LD50 (female) > 2000 mg/kg bw
Under the test conditions, and according to the OECD TG 420 criteria, the LD50 cut-off value is considered to be greater than 5000 mg/kg bw, therefore it is not classified according to Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The key study is GLP-compliant and of high quality (Klimisch score = 1)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Not required at a REACH Annex VII level
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Not required at a REACH Annex VII level
Additional information
Acute toxicity: oral
In an acute oral toxicity study performed according to OECD Guideline 420 and in compliance with GLP, following a sighting test at dose levels of 300 mg/kg body weight and 2000 mg/kg body weight, a further group of four fasted females Wistar rats was given a single oral dose of test item, as a solution in DMSO, at a dose level of 2000 mg/kg body weight. Animals were then observed for mortality, clinical signs and body weights for 14 days and were all sacrificed for macroscopic examination.
There were no deaths and no clinical signs during the study. All animals showed expected gains in body weight. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 14.
Oral LD50 (female) > 2000 mg/kg bw
Under the test conditions, and according to
the OECD TG 420 criteria, the LD50 cut-off value is considered to be
greater than 5000 mg/kg bw.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity via Oral route:
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS as the oral LD50 is higher than 5000 mg/kg bw.
Acute toxicity via Dermal route:
No data was available.
Acute toxicity (Inhalation):
No data was available.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 and to the GHS as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3) according to the Regulation (EC) No. 1272/2008 and to the GHS are not met since narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
No data was available.
Specific target organ toxicity: single exposure (Inhalation):
No data was available.
Based on its physical state (solid - partly melted at 40°C, but very viscous), the substance is not classified for aspiration hazard according to CLP Regulation and GHS.
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.
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