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EC number: 615-768-8 | CAS number: 72480-17-2
- 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:
- The study was conducted between 14 July 2015 and 06 August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- 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
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2-Pentanone, 4-methyl-, reaction products with 2-(2-aminoethoxy)ethanol
- EC Number:
- 615-768-8
- Cas Number:
- 72480-17-2
- Molecular formula:
- C10 H21 N O2
- IUPAC Name:
- 2-Pentanone, 4-methyl-, reaction products with 2-(2-aminoethoxy)ethanol
- Test material form:
- other: Liquid
- Details on test material:
- Batch: BBD02083V1ZKChemical Name: 2-[2-(4-methylpentan-2-ylideneamino)ethoxy]ethanolPhysical state / Appearance: Pale yellow to pale green liquidExpiry Date: 07 September 2017Storage Conditions: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Wistar (RccHan™:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight at the start of treatment.The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.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.JustificationRats are the preferred species of choice as historically used for safety evaluation studies and are specified in the appropriate test guidelines.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Test Item Formulation and Experimental PreparationFor the purpose of the study the test item was freshly prepared, as required, as a solution in distilled water. The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.A total of five animals were therefore treated at a dose level of 300 mg/kg in the study.All animals were dosed once only 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.
- Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- A single animal was treated at 300 mg/kg.A single animal was treated at 2000 mg/kg.An additional four animals were treated at 300 mg/kg.
- Control animals:
- no
- Details on study design:
- 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.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 surviving 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:
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.
Results and discussion
- Preliminary study:
- See below
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose Level - 2000 mg/kgThe animal was killed for humane reasons, 6 days after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. Dose Level - 300 mg/kgThere were no deaths.
- Clinical signs:
- other: Dose Level - 2000 mg/kgSigns of systemic toxicity noted were hunched posture, pilo-erection, labored and noisy respiration, increased respiratory rate, distended abdomen, pallor of the extremities and emaciation. Dose Level - 300 mg/kgNo signs of systemi
- Gross pathology:
- Dose Level - 2000 mg/kgAbnormalities noted at necropsy were pale liver, pale kidneys and gaseous stomach and small and large intestines. Dose Level - 300 mg/kgNo abnormalities were noted at necropsy.
Any other information on results incl. tables
Individual Clinical Observations and Mortality Data -2000mg/kg
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing | Effects Noted During Period After Dosing | ||||||||
½ | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | ||
2000 | 2-0 Female | 0 | 0 | H | H | H | HP | HPRlRn | HPRlRn | HPRlRnDa | HPRlRiDaEEmX* |
0 = No signs of systemic toxicity
H = Hunched posture
P = Pilo-erection
Rl = Labored respiration
Rn = Noisy respiration
Ri = Increased respiratory rate
Da = Distended abdomen
E = Pallor of the extremities
Em = Emaciation
X* = The animal was killed for humane reasons, 6 days after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence
Individual Body Weights and Body Weight Changes -2000mg/kg
Dose Level mg/kg | Animal Number and Sex | Body Weight (g) at Day | Body Weight (g) | Body Weight Gain (g) | |||
0 | 7 | 14 | 1 | 2 | |||
2000 | 2-0 Female | 168 | - | - | 126 | - | - |
- = Animal dead
Individual Necropsy Findings -2000 mg/kg
Dose Level | Animal Number | Time of Death | Macroscopic Observations |
2000 | 2-0 Female | Humanely killed Day 6 | Liver: pale Kidneys: pale Stomach: gaseous Small intestine: gaseous Large intestine: gaseous |
Individual Clinical Observations and Mortality Data -300mg/kg
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing | Effects Noted During Period After Dosing | ||||||||||||||||
½ | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
300 | 1-0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3-0 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-1 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-2 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
3-3 Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0 = No signs of systemic toxicity
Individual Body Weights and Body Weight Changes -300mg/kg
Dose Level mg/kg | Animal Number | Body Weight (g) at Day | Body Weight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
300 | 1-0 Female | 173 | 190 | 200 | 17 | 10 |
3-0 Female | 151 | 165 | 178 | 14 | 13 | |
3-1 Female | 179 | 190 | 216 | 11 | 26 | |
3-2 Female | 152 | 163 | 176 | 11 | 13 | |
3-3 Female | 150 | 167 | 182 | 17 | 15 |
Individual Necropsy Findings-300mg/kg
Dose Level | Animal Number | Time of Death | Macroscopic Observations |
300 | 1-0 Female | Killed Day 14 | No abnormalities detected |
3-0 Female | Killed Day 14 | No abnormalities detected | |
3-1 Female | Killed Day 14 | No abnormalities detected | |
3-2 Female | Killed Day 14 | No abnormalities detected | |
3-3 Female | Killed Day 14 | No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
Following a sighting test at dose levels of 2000 mg/kg and 300 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a solution in distilled water, at a dose level of 300 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. The animal treated at a dose level of 2000 mg/kg was killed for humane reasons, 6 days after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. There were no deaths at a dose level of 300 mg/kg.
Clinical Observations. Signs of systemic toxicity noted in the animal treated at a dose level of 2000 mg/kg were hunched posture, pilo-erection, labored and noisy respiration, increased respiratory rate, distended abdomen, pallor of the extremities and emaciation. There were no signs of systemic toxicity noted at a dose level of 300 mg/kg.
Body Weight. Surviving animals showed expected gains in body weight.
Necropsy. Abnormalities noted at necropsy of the animal treated at a dose level of 2000 mg/kg were pale liver, pale kidneys, gaseous stomach and gaseous small and large intestines. No abnormalities were noted at necropsy of animals treated at a dose level of 300 mg/kg.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System-Category 4).
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