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EC number: 947-349-3 | 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:
- 24/05/2016 - 18/07/2016
- 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)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 2-[dimethyl({3-[(10E,13E)-nonadeca-10,13-dienamido]propyl})azaniumyl]acetate
- Molecular formula:
- C25H47N2O3 (if R= C18:2)
- IUPAC Name:
- 2-[dimethyl({3-[(10E,13E)-nonadeca-10,13-dienamido]propyl})azaniumyl]acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- The test material corresponded to the approximately 45% of the registration substance. The given dose refers to the amount of the registration substance.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sainath Agencies, Bapujinagar, Musheerabad, Hyderabad 500 020
- Age at study initiation: 8 - 9 Weeks
- Weight at study initiation: 189.4 to 209.2 g
- Housing:Animals were housed individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage at least once a week. Bedding: steam sterilized corn cob was used and changed once a week along with the cage.
- Diet (ad libitum):Hypro Rat & Mice Pellet Feed, manufactured by Pranav Agro Industries Ltd., Pune 411 030, Maharashtra, India, was provided to animals.
- Water (ad libitum):Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai 400 001, India was provided to animals in polycarbonate bottles with stainless steel sipper tubes.
- Acclimation period: After physical examination, the animals were acclimatized for five to seven days before treatment. Animals were observed once daily during acclimatization period. Females were nulliparous and non-pregnant.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%):65 to 67%
- Air changes (per hr):12.9 to 13.1 air changes/hour
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours dark cycle
IN-LIFE DATES: From: 27 May 2016 To: 17 June 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The dose level of 2000 mg/kg refers to the active ingredient, the registration substance
- Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED:2000 mg/kg
DOSAGE PREPARATION : The undiluted test item as supplied by the sponsor was administered based on the density of the test item i.e., 1.05 g/cm3 at 20 ºC (as per TIDS provided by the sponsor) and the dose volume was 4.52 mL/kg body weight, i.e., [1.90 (dose volume as per density) x 2.38 (correction factor)] to attain the dose of 2000 mg/kg body weight (G1-FTS) as oral gavage to overnight fasted (16 to 18 hours) 3 female rats.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As per the Material Safety Data Sheet provided by the Sponsor, the acute oral LD50 rat is > 2000 mg/kg body weight. Hence the test was started as per Annex 2d of the OECD 423 test guideline. The starting dose was 2000 mg/kg body weight (G1-FTS). No test item-related mortality was observed; hence test was continued with same dose with three additional female rats second step (G1-STS). The subsequent dosing was done at approximately 48 hours after the first dosing- Doses:
- Doses: 2000 mg/kg body weight (first treatment step and second treatment step)
- No. of animals per sex per dose:
- 3 females/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15 post administration. The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology.
Results and discussion
- Preliminary study:
- Body weights, body weight changes and pre-terminal deaths are presented in Table 1.
Individual clinical signs and necropsy findings are presented in Table 2.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- No abnormality detected at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity of the registration substance was investigated according to the OECD Gudieline 423. Six female rats were treated once with the registration substance at dose of 2000 mg/kg bw. No effect was observed. The LD50 of the registration substance was determined to be higher than 2000 mg/kg bw. No classification is warranted.
- Executive summary:
The acute oral toxicity of the registration substance was investigated according to the OECD Gudieline 423. Six female rats were treated once with the registration substance at dose of 2000 mg/kg bw. No effect was observed. The LD50 of the registration substance was determined to be higher than 2000 mg/kg bw. No classification is warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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