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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 814-233-8 | CAS number: 444649-70-1
- 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:
- From June 09, 2015 to June 26, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- typing error
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Molecular formula:
- C16H28O5
- IUPAC Name:
- Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Reference substance name:
- Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Molecular formula:
- C17H30O5
- IUPAC Name:
- Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Reference substance name:
- glycerol 1,3-dineodecanoate
- Molecular formula:
- C23H44O5
- IUPAC Name:
- glycerol 1,3-dineodecanoate
- Reference substance name:
- Sum of other constituents, each of them at <1%
- Molecular formula:
- Not available
- IUPAC Name:
- Sum of other constituents, each of them at <1%
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- Batch no.: JBGJ0045R
Appearance: clear yellowish liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Velaz Prague, Czech Republic
Age: At least 8-12 weeks; female animals were non-pregnant and nulliparous
Acclimatization: at least 5 days
Temperature: 22 ± 2°C, relative humidity : 55 ± 10% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin (Altromin Spezialfutter GmbH, Germany, ad libitum
Water: tap water for human consumption, ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- The required amount of the test substance (according to the body weight and dose) was mixed with vehicle (carboxymethyl cellulose - 1% solution) shortly before administration. The test substance was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the animals were weighted and the test substance administered. After the test isubstance had been administered, food was withheld for further 3-4 hours.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 6 females
- Control animals:
- no
- Details on study design:
- - Animals were observed individually immediately after the administration of the test substance and then ½, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Individual weights of animals were determined shortly before the test substance was administered and at weekly thereafter. Weight differences after first and second week after application were calculated and recorded.
- All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal.
Results and discussion
- Preliminary study:
- The starting dose was selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg bw. Available information indicated that the test substance is likely to be nontoxic considering to acute toxicity. A limit dose of 2000 mg/kg bw was used as starting dose. Group of 3 rat’s females were dosed. Test substance-related mortality was not produced during 24 hours; group of 3 rat’s females and group of 3 rat’s males were tested at the same dose.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All 6/6 females and 3/3 males survived the limit dose 2000 mg/kg bw. No further dosing was necessary.
- Clinical signs:
- other: No mortality was observed during the study. Animals lived through observation period without important visible signs of intoxication. Neither change of health nor negative reactions were registered.
- Gross pathology:
- All animals (6 females and 3 males) were necropsied. During necropsy, no macroscopically changes were noticed.
Any other information on results incl. tables
Based on the results, the test substance was classified in category 5/Unclassified with the cut off LD50 ≥ 5000 mg/kg bw, after single oral administration to Wistar rats.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- does not need to be classified
- Conclusions:
- Under the study conditions, the rat LD50 was determined to be ≥ 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423, in compliance with GLP. The test substance was administered by gavage to 6 female and 3 male rats at a limit dose of 2000 mg/kg bw. All 6/6 females and 3/3 males survived the limit dose of 2000 mg/kg bw. No further dosing was necessary. No body weight losses were recorded one and two weeks after administration of the test substance. No important symptoms were observed at the dosage of 2000 mg/kg bw during first 4 h neither in females nor in males or in 14 day observation period. During necropsy, no macroscopically changes were noticed. Under the study conditions, the rat LD50 was determined to be ≥ 2000 mg/kg bw (Hozova, 2015).
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.