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EC number: 800-884-5 | CAS number: 1154308-86-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide
- EC Number:
- 800-884-5
- Cas Number:
- 1154308-86-7
- Molecular formula:
- C11 H23 N1 O2
- IUPAC Name:
- N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK, Margate
- Age at study initiation: 8 to 10 weeks
- Fasting period before study: Overnight on the day before dosing
- Housing: 3 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21°C
- Humidity (%): 46% to 59%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: To: 17 July 2012 to 11 September 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.2 mL/kg
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Acute Toxicity on Sponsor's Safety Data Sheet stated that the oral LD50 in rats is >5000 mg/kg
The test item was administered as supplied (ie not formulated in a vehicle)
MAXIMUM DOSE VOLUME APPLIED: 2.2 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The Acute Toxicity Data section of the Sponsor's Safety Data Sheet stated that the acute oral LD50 in rats is >5000 mg/kg - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 6 at 300 mg/kg and 6 at 2000 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations at least 5 times on the day of dosing, then daily for 14 days. Body weights on Days 1, 8 and 15
- Necropsy of survivors performed: yes (also decedents)
- Other examinations performed: none - Statistics:
- None
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Two of 6 animals given 2000 mg/kg bw were euthanized during the study.
- Mortality:
- Two of the 6 animals that were treated with the substance at a dose level of 2000 mg/kg (Group 2 Animal Nos. 6 and 4) were euthanised at approximately 3½ h and 5¾ h post dose, respectively, because of the severity of their clinical signs.
There were no deaths among the Group 1 animals treated with the substance at a dose level of 2000 mg/kg or among the 6 animals that received the 300 mg/kg dose level (Groups 3 and 4). - Clinical signs:
- other: All 6 animals treated at 2000 mg/kg displayed subdued behaviour and rolling gait within approximately 15 min of dosing and all were prostrate within approximately 30 min. Five of these animals displayed hunched posture, piloerection and staggering and 5
- Gross pathology:
- Necropsy revealed no macroscopic abnormalities in any animal.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 4 based on CLP criteria
- Conclusions:
- Under the conditions of the study, the oral LD50 value was considered to be 2000 mg/kg bw, indicating low acute oral toxicity potential.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance, in Sprague-Dawley rats according to OECD Guideline 423, in compliance with GLP. Two groups of six fasted females were treated with the test substance at a dose level of and 2000 (Group 1 and 2) and 300 mg/kg bw (Group 3 and 4). The animals were observed for up to 14 days after the day of dosing. The following parameters and end points were evaluated in this study: clinical signs, body weights, body weight changes, and gross necropsy findings. Two of the 6 animals that were treated with the substance at a dose level of 2000 mg//kg bw (Group 2) bw were euthanised at approximately 3½ h and 5¾ h post dose, respectively, because of the severity of their clinical signs. Signs were noted in these animals from 5 min post dose and at time of euthanasia included respiratory difficulties, unresponsiveness, watery discharge from the eyes and coldness to the touch. All 6 animals treated at 2000 mg/kg bw displayed subdued behaviour and rolling gait and were prostrate within approximately 30 min of dosing. Other signs noted in Day 1 included hunched posture, piloerection, staggering and slow and irregular respiration. Lowered body posture was recorded in all of these animals during the first 2 days of the observation period. Among surviving animals, the majority of these signs had resolved by Day 2 and all had resolved by Day 3. In animals treated at 300 mg/kg bw the clinical signs on Day 1 included subdued behaviour, hunched posture, staggering, piloerection and partial eye closure. All signs had resolved by Day 2. The body weight gains of animals treated at 300 mg/kg bw were considered to be acceptable for rats of this age and strain. Lower body weight gains were recorded in surviving animals treated at 2000 mg/kg bw. No macroscopic abnormalities were recorded in any of the animals at necropsy. Under the conditions of the study, the oral LD50 value was considered to be 2000 mg/kg bw (Robertson, 2012).
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