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Diss Factsheets
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EC number: 947-155-9 | 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:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2001
- Deviations:
- no
- Remarks:
- No deviations ocurred that impacted the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate
- EC Number:
- 947-155-9
- Molecular formula:
- C11H20O2
- IUPAC Name:
- Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate
- Test material form:
- liquid
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 11
- Purity, including information on contaminants, isomers, etc.: 99.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Kept in a room with controls set to maintain 18°C to 24°C
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): None, dosed neat.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : The test article was dosed neat.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 205-244 g
- Fasting period before study: Overnight
- Housing: Animals were individually housed in stainless steel wire mesh cages equipped with an automatic watering valve.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC Certified Rodent LabDiet 5002 meal was provided ad libitum
- Water (e.g. ad libitum): Municipal tap water after treatment by reverse osmosis and ultraviolet irradiation was freely available to each animal via an automatic watering system
- Acclimation period: At least five days.
- Microbiological status when known : No data.
- Method of randomisation in assigning animals to test and control groups : Randomized via a computerized randomization program.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 18 June 2019 To: 05 July 2019
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: None, dosed neat.
MAXIMUM DOSE VOLUME APPLIED: 2.308 mL/kg body weight.
DOSAGE PREPARATION (if unusual): Neat - Doses:
- 2,000 mg/kg body weight.
- No. of animals per sex per dose:
- 5 females were utilized in the study.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at the time of dosing and approximately 15 ± 5 minutes and 1, 2, and 4 hours postdosing on Day 1 and once daily thereafter for 14 days. Body weights were obtained and recorded on Days 1 (initiation), 8, and 15 (termination).
- Necropsy of survivors performed: yes
- Clinical signs including body weight: The rats were observed at the time of dosing and approximately 15 ± 5 minutes and 1, 2, and 4 hours postdosing on Day 1 and once daily thereafter for 14 days. Body weights were obtained and recorded on Days 1 (initiation), 8, and 15 (termination).
- Other examinations performed: clinical signs, body weight,gross necropsy - Statistics:
- At the termination of the project, all data will be collected and the acute oral median lethal dose (LD50) will be determined using the EPA-provided statistical program AOT425StatPgm.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived to the scheduled necropsy.
- Clinical signs:
- other: There were no abnormal clinical signs observed during the study.
- Gross pathology:
- No test article-related observations were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study, the acute oral LD50 of MTDID 44428 is greater than 2,000 mg/kg body weight.
- Executive summary:
The acute oral lethality of MTDID 44428 was evaluated in female Sprague Dawley rats. The study was conducted according to OECD 423 in compliance with OECD GLP. Female rats (5) were dosed neat (no vehicle) via oral gavage with 2,000 mg/kg bw MTDID 44428. The rats were observed at the time of dosing and approximately 15 ± 5 minutes and 1, 2, and 4 hours postdosing on Day 1 and once daily thereafter for 14 days. Body weights were obtained and recorded on Days 1 (initiation), 8, and 15 (termination). All rats survived with no clinical signs of toxicity and no abnormal body weight changes. No treatment-related findings were observed upon gross necropsy. Based on the results of the study, the acute oral LD50 of MTDID 44428 is greater than 2,000 mg/kg body weight.
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