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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-603-5 | CAS number: 908145-87-9
- 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:
- 10 December 2009 to 12 January 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
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
- Limit test:
- no
Test material
- Reference substance name:
- 1,5-diethyl (2S)-2-{[4-(4-oxobutyl)phenyl]formamido}pentanedioate
- EC Number:
- 700-603-5
- Cas Number:
- 908145-87-9
- Molecular formula:
- C20 H27 N O6
- IUPAC Name:
- 1,5-diethyl (2S)-2-{[4-(4-oxobutyl)phenyl]formamido}pentanedioate
- Details on test material:
- Pure active sample of Compound 2945989 was used to perform the testing.
Lot Number: Z84-H70580-095
Potency: Assume 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were housed in suspended wire cages, 5/sex/cage prior to dosing and 3/sex/cage following dosing.
Paper bedding was placed beneath the cages and changed at least three times/week.
Fresh PMI Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing.
Water was available ad libitum.
The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test article was administered oraly by syringe and a dosing needle on an mg/kg basis.
- Doses:
- The dose was based on the dry weight of the test article.
A single dose was administered orally by syringe and dosing needle at a dose level of 300 mg/kg or 2000 mg/kg. - No. of animals per sex per dose:
- Initially, three healthy male and three healthy female rats were dosed orally with Compound 2945989, at 300 mg/kg. Since there was no toxicity
noted at this level, an additional three healthy male and three healthy female rats were dosed orally at 2000 mg/kg. - Control animals:
- no
- Details on study design:
- Type and frequency of observations made after dosing:
In Vivo - Animals were observed ½, 1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly and at termination.
Post Mortem – All animals were humanely sacrificed using CO2 and were examined for gross pathology following study termination.
The test article was assigned to a toxic category based on the mortality response noted. - Statistics:
- An estimate of the LD50 was made based on mortality that occurred during the study.
Results and discussion
- Preliminary study:
- not a fixed dose study
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- ca. 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All six animals survived
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All six animals survived
- Mortality:
- 300mg/kg - no mortality observed
2000mg/kg - no mortality observed - Clinical signs:
- other: 300mg/kg: No physical signs were observed. Body weight changes were normal in 5/6 animals. One animal lost weight. 2000mg/kg: No physical signs were observed. Body weight changes were normal for both sexes. Necropsy results were normal
- Gross pathology:
- 300mg/kg - Necropsy results were normal in 5/6 animals. One animal was noted with a larger than normal thymus.
2000mg/kg - Necropsy results were normal
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Compound 2945989, Lot# Z84 -H70580 is considered to be in GHS Acute Toxic Category 5 or unclassified under the EU CLP Regulations.
- Executive summary:
Initially, three healthy male and three healthy female Sprague Dawley rats were dosed orally with Compound 2945989, Lot# Z84-H70580-095 at 300 mg/kg. Since there was no toxicity noted at this level, an additional three healthy male and three healthy female Sprague Dawley rats were dosed orally at 2000 mg/kg. The rats were observed ½, 1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology. The test article was assigned to a toxic category based on the mortality response noted.
Summary:
300 mg/kg: All six animals survived the single 300 mg/kg oral dose. No physical signs were observed. Body weight changes were normal in 5/6 animals. One animal lost weight. Necropsy results were normal in 5/6 animals. One animal was noted with a larger than normal thymus.
2000 mg/kg: All six animals survived the single 2000 mg/kg oral dose. No physical signs were observed. Body weight changes were normal for both sexes. Necropsy results were normal.
Conclusion: The LD50 is greater than 2000 mg/kg. Compound 2945989, Lot# Z84-H70580-095 is considered to be in Acute Toxic Category 5 or unclassified under EU CLP Regulations.
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.