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EC number: 612-975-5 | CAS number: 6225-08-7
- 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
- Study period:
- 27 October 2016 to 17 December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Acute Oral Toxicity - Acute Toxic Class Method" adopted on 17 December 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- N,N-dimethylnonanamide
- EC Number:
- 612-975-5
- Cas Number:
- 6225-08-7
- Molecular formula:
- C11H23NO
- IUPAC Name:
- N,N-dimethylnonanamide
- Details on test material:
- - Name of test material (as cited in study report): N,N-Dimethylnonanamide
- Synonyme: Genagen PA
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: 112-2016-11 D
- Expiration date of the batch: May 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool and dry (+2 to +8°C)
- Solubility of the test substance in the vehicle: Corn oil (200 mg/mL)
FORM AS APPLIED IN THE TEST: Liquid
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: 167.21 g to 177.61 g
- Fasting period before study: overnight (16 to 18 hours) prior to dosing
- Housing:Three animals were housed in standard polypropylene cage (Size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): Teklad Certified (2014SC) Global 14 % Protein Rodent Maintenance Diet (Sterilizable) manufactured by Envigo
- Water (e.g. ad libitum):Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier
- Acclimation period:Start: 28 October 2016; End: 09 November 2016
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0°C to 22.5°C
- Humidity (%): 50% to 65%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 28 October 2016; To: 24 November 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Step-I & Step-I Confirmation: 30 mg/mL;
Step-II & Step-II Confirmation: 200 mg/mL;
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle:As per the in-house solubility/suspendibility test, test item formed a suspension in corn oil.
- batch no: C-167
- Purity: Pure
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION: A small quantity of vehicle was added to test item and mixed well and thereafter the formulation was transferred into measuring cylinder. Again, a small quantity of vehicle was added to the mortar and rinsed and transferred into the measuring cylinder. Finally the volume was made up to required quantity with vehicle to get a desired volume
CLASS METHOD
- Rationale for the selection of the starting dose: As no information on LD50 of Genagen PA/ N,N-Dimethylnonanamide in rats was available, a starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight - Doses:
- Step-I and Step I confirmation: 300 mg/kg body weight;
Step-II and Step II confirmation: 2000 mg/kg body weight - No. of animals per sex per dose:
- 3 females per step per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily once for clinical signs and weekly body weights
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality at both tested doses (300 and 2000 mg/kg body weight)
- Clinical signs:
- other: No clinical signs of toxicity observed at both tested doses (300 and 2000 mg/kg body weight)
- Gross pathology:
- No gross pathological changes were observed in any of the animals at 300 mg/kg body weight in Step I and Step I confirmation and 2000 mg/kg body weight in Step II and Step II confirmation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity of Genagen PA was investigated according to the Guideline OECD 423. Rats were treated per gavage at dose of up to 2000 mg/kg bw. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of Genagen PA was investigated according to the Guideline OECD 423. Rats were treated per gavage at dose of up to 2000 mg/kg bw. No effect was observed. The LD50 is found to be higher than 2000 mg/kg bw.
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