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EC number: 946-978-0 | 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
Endpoint summary
Administrative data
Description of key information
The acute toxicity of Reaction mass of 2-Propenoic acid, 2-methyl-, 2-dodecylhexadecyl ester and 2-Propenoic acid, 2-methyl-, 2-tetradecyloctadecyl ester via the oral route was
evaluated during a study performed according to the OECD Testing Guideline 420. The study was GLP-compliant.
The fixed dose method was used. One female Wistar rat received by gavage a single dose of 300 mg/kg bw in corn oil. In the absence of observable toxicity at 300 mg/kg bw, an animal was treated at 2,000 mg/kg bw. Considering that no mortality or clear signs of toxicity were observed, four additional female Wistar rats were treated at 2,000 mg/kg bw.
Following exposure to the test substance, animals were observed for 14 days. There were no deaths nor clinical signs of reaction to treatment during the study. All animals were considered to have achieved satisfactory body weight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
It can be concluded that Reaction mass of 2-Propenoic acid, 2-methyl-, 2-dodecylhexadecyl ester and 2-Propenoic acid, 2-methyl-, 2-tetradecyloctadecyl ester has a LD50 > 2,000 mg/kg bw via the oral route.
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:
- From 29 August 2019 to 24 September 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Ltd
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 158 to 170 g
- Fasting period before study: Overnight before dosing
- Housing: solid bottomed polycarbonate cages with a stainless steel mesh lid
- Diet: standard rodent diet (Teklad 2014C Diet) ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least five days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): Periodic checks were made on the number of air changes in the animal rooms.
- Photoperiod (hrs dark / hrs light): 12h/12h - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle: 10 mL/kg body weight
- Justification for choice of vehicle: A vehicle trial was conducted; water resulted in an offwhite, hazy emulsion which separated quickly and was therefore determined unsuitable, 1% methyl cellulose was considered to be incompatible due to the test items previous incompatibility with water, and therefore, corn oil was tested – which resulted in a clear, yellow solution and determined suitable for formulation. - Doses:
- 300 mg/kg bw was chosen as the starting dose.
In the absence of mortality or clear evident toxicity at a dose level of 300 mg/kg, additional testing was performed at 2,000 mg/kg bw. - No. of animals per sex per dose:
- One animal at 300 mg/kg bw.
Five animals at 2,000 mg/kg bw. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cages of rats were checked at least twice daily for any mortalities. The weight of each rat was recorded on Days -1, 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of the brain, cecum, duodenum, heart, kidneys, small and large intestine, liver, lungs and bronchi, spleen, stomach, subcutaneous tissue and urinary bladder was recorded.
- Other examinations performed: Animals were observed soon after dosing and at frequent (approximately hourly) intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity, where appropriate, of any clinical signs and the time were recorded at each observation. - Preliminary study:
- In the absence of mortality or toxicity at 300 mg/kg bw and 2,000 mg/kg bw, definitive test was conducted at 2,000 mg/kg bw
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment throughout the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following an acute oral toxicity experiment in rats, it was determined that Reaction mass of 2-Propenoic acid, 2-methyl-, 2-dodecylhexadecyl ester and 2-Propenoic acid, 2-methyl-, 2-tetradecyloctadecyl ester was not acutely toxic via the oral route under the conditions of the study. No mortality was observed at the highest dose over a 14-day period, therefore the LD50 is concluded to be >2000 mg/kg bw. The substance does not meet the criteria for classification according to Regulation 1272/2008.
- Executive summary:
The acute toxicity of Reaction mass of 2-Propenoic acid, 2-methyl-, 2-dodecylhexadecyl ester and 2-Propenoic acid, 2-methyl-, 2-tetradecyloctadecyl ester via the oral route was
evaluated during a study performed according to the OECD Testing Guideline 420. The study was GLP-compliant.
The fixed dose method was used. One female Wistar rat received by gavage a single dose of 300 mg/kg bw in corn oil. In the absence of observable toxicity at 300 mg/kg bw, an animal was treated at 2,000 mg/kg bw. Considering that no mortality or clear signs of toxicity were observed, four additional female Wistar rats were treated at 2,000 mg/kg bw.
Following exposure to the test substance, animals were observed for 14 days. There were no deaths nor clinical signs of reaction to treatment during the study. All animals were considered to have achieved satisfactory body weight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
It can be concluded that2 Reaction mass of 2-Propenoic acid, 2-methyl-, 2-dodecylhexadecyl ester and 2-Propenoic acid, 2-methyl-, 2-tetradecyloctadecyl ester has a LD50 > 2,000 mg/kg bw via the oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Following an acute oral toxicity experiment in rats, it was determined that Reaction mass of 2-Propenoic acid, 2-methyl-, 2-dodecylhexadecyl ester and 2-Propenoic acid, 2-methyl-, 2-tetradecyloctadecyl ester was not acutely toxic via the oral route under the conditions of the study. No mortality was observed at the highest dose over a 14-day period, therefore the LD50 is concluded to be >2000 mg/kg bw. The substance does not meet the criteria for classification according to Regulation (EC) 1272/2008.
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