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EC number: 806-919-0 | CAS number: 1356964-77-6
- 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:
- 04 February 2014 to 24 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OPPTS 870.1100 and OECD 425 test guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
Test material
- Reference substance name:
- N,N-dimethyldec-9-enamide
- EC Number:
- 806-919-0
- Cas Number:
- 1356964-77-6
- Molecular formula:
- C12H23NO
- IUPAC Name:
- N,N-dimethyldec-9-enamide
- Test material form:
- other: clear colourless liquid
- Details on test material:
- - Name of test material (as cited in study report): MET-10U
- Physical state: clear colourless liquid
- Analytical purity:
- Lot/batch No.: 5104-014-006 Dec. 5, 2013
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Indianapolis, Indiana
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 203 - 257 g
- Fasting period before study: overnight
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Purina rat chow, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: 04 February 2014 To: 24 February 2014
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.475 ml
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Limit dose- Doses:
- 2000, 550, 175 mg/kg
- No. of animals per sex per dose:
- 3, 4, 3, females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed frequently on day of dosing and dailt thereafter for 14 days. Bodyweights taken on Days 1, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The LD50 was calculated according to the Agency's developed software package (AOT425StatPgm) for performing the test and calculation of the LD50.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 265.4 - 1 520
- Mortality:
- 3 of 3 animals dosed with 2000 mg/kg died prematurely, 2 of 4 animals dosed with 550 mg/kg died prematurely, there were no premature mortalities in 3 animals dosed with 175 mg/kg.
- Clinical signs:
- other: Clinical signs were observed on the first day of dosing in all animals dosed with 550 or 2000 mg/kg.
- Gross pathology:
- No gross observations except for stomach and GI tract distended with gas and fluid in one animal dosed with 2000 mg/kg and one animal dosed with 550 mg/kg.
Any other information on results incl. tables
Results for the individual animals are given in the attached document.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
- Conclusions:
- The statistical estimated acute oral LD50 was determined to be 550 mg/kg body weight and a 95% PL confidence interval of 265.4 mg/kg to 1520 mg/kg. Therefore the substance would be classified EPA Toxicity Category III for acute oral toxicity. According to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, the substance is classified as Category 4.
- Executive summary:
Introduction
The substance was tested for acute oral toxicity in accordance with OPPTS Guidelines and the OECD 425 'Up and Down Method'.
Methods
The substance was administered by gavage at various dose levels according to the Up and Down procedure to female rats. Dose levels of 2000, 550 and 175 mg/kg were administered according to the software package AOT 425StatPgm.
Results
The statistical estimated acute oral LD50 was determined to be 550 mg/kg body weight and a 95% PL confidence interval of 265.4 mg/kg to 1520 mg/kg.
Conclusion
The substance would be classified as EPA Toxicity Category III for acute oral toxicity. According to Regulation (EC) No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, the substance is classified as Category 4.
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