Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 264-391-1 | CAS number: 63663-21-8
- 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:
- 30 June 1988 to 12 September 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The acute toxicity of the test material carried out in mice by oral administration.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (S)-N,N'-dibutyl-2-[(1-oxododecyl)amino]glutaramide
- EC Number:
- 264-391-1
- EC Name:
- (S)-N,N'-dibutyl-2-[(1-oxododecyl)amino]glutaramide
- Cas Number:
- 63663-21-8
- Molecular formula:
- C25H49N3O3
- IUPAC Name:
- (2S)-N,N'-dibutyl-2-dodecanamidopentanediamide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 weeks old
- Weight at study initiation: 25.5 to 29.2 g
- Fasting period before study: Animals were fasted for approximately 8 hours before administration. Feeding resumed 2 hours after administration.
- Housing: Animals were kept in cages made from polyethylene with 10 animals per cage.
- Diet: ad libitum
- Water: Animals had free access to water through feed-water bottles.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: All-fresh ventilation of 12 cycles per hour
- Photoperiod: 12 hours, from 7 A.M. to 7 P.M.; between 200 and 500 lx
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- TEST MATERIAL ADMINISTRATION:
- The test material was prepared as a 5.0 % suspension using olive oil. (Equivalent to 2.0 g/kg, by administrating 0.4 mL per 10 g of body weight.)
The test material was orally administered to the animals at a dosage of 2.0 g/kg. This route was selected because it is the one with the highest risk of accidental exposure, and also because it is potentially the route causing maximum exposure inside living bodies.
Oral administration of a volume of 40 mL per 1 kg of body weight was carried out. Olive oil, which was used as a vehicle, was administered to the control group in a similar manner.
The test material was administered once. - Doses:
- Dosage: 2.0 g.kg
Dosage volume: 40 mL per 1 kg of body weight - No. of animals per sex per dose:
- Only male animals were used.
Group 1: Olive oil was administered to 10 animals at a dosage volue of 40 mL/kg. (negative control)
Group 2: Test material was administered to 10 animals at a dosage of 2.0 g/kg and a dosage volume of 40 mL/kg. - Control animals:
- yes
- Details on study design:
- Dates were counted based on Day 1 being the day that administration was carried out.
From Day 1 until Day 15, observations were carried out once a day as to whether any of the animals died.
OBSERVATION OF CLINICAL SIGNS:
On Day 1, observation of acute toxicity symptoms was carried out immediately after administration up until approximately 2 hours after administration. In addition, observation was carried out twice (once in the morning, once in the afternoon) on Day 2. From Day 3 to Day 15, observation of the number of surviving animals and general conditions was carried out once a day.
MEASUREMENT OF BODY WEIGHT:
The body weight of all remaining animals was measured on Days 1, 2, 8, and 15 using an electric scale (Shimadzu EB-2800, Shimadzu Corporation). - Statistics:
- The body weights were compared to those of the animals in the control group based on Student’s t-test.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed throughout the study.
- Clinical signs:
- other: 6 hours after administration, eyelid closure in 2 animals, soft stools in 2 animals, and diarrhoea in 5 animals were observed, but the animals recovered on Day 2. Moistness around the root of the tail was also observed in all of the animals in the control
- Gross pathology:
- There were no abnormalities observed in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Conclusions:
- Under the conditions of this study, it was estimated that the LD50 value of the test material is greater than 2.0 g/kg body weight.
- Executive summary:
The acute oral toxicity of the test material was investigated in a study to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.
During the study, 20 male mice were put into 2 groups of 10. Group 1 was administered with olive oil (the vehicle) and group 2 was administered with the test material at a dosage of 2.0 g/kg and a dosage volume of 40 mL/kg.
The body weight of all remaining animals was measured on Days 1, 2, 8, and 15 using an electric scale. On Day 1, observation of acute toxicity symptoms was carried out immediately after administration up until approximately 2 hours after administration. In addition, observation was carried out twice (once in the morning, once in the afternoon) on Day 2. From Day 3 to Day 15, observation of the number of surviving animals and general conditions was carried out once a day.
Throughout the study, no deaths were observed. Observations were also made on clinical signs and 6 hours after administration, eyelid closure in 2 animals, soft stools in 2 animals, and diarrhea in 5 animals were observed, but the animals recovered on Day 2. Moistness around the root of the tail was also observed in all of the animals in the control group, but the animals recovered on Day 2.
Under the conditions of the study, it was estimated that the LD50 value of the test material is greater than 2.0 g/kg body weight.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.