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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 414-810-0 | CAS number: - A-88820.605
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 17 - Feb 28, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- Subacute Toxicity (oral)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of International Trade and Industry Notification Nr.2
- GLP compliance:
- yes
- Remarks:
- 21 CFR 28
- Limit test:
- no
Test material
- Reference substance name:
- A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
- EC Number:
- 414-810-0
- EC Name:
- A mixture of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
- Cas Number:
- 144163-85-9
- Molecular formula:
- Empirical formula: C25H35N2O5
- IUPAC Name:
- butanedioic acid; propan-2-ol; bis(tert-butyl N-[(4R)-5-amino-4-hydroxy-1,6-diphenylhexan-2-yl]carbamate)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley Crl:CD®BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michiga
- Age at study initiation: 28 - 35 days
- Weight at study initiation: 170 - 240g at the start of treatment.
- Housing: ventilated, hanging stainless steel, wire bottomed cages.
- Diet: Certified Rodent Chow, ad libitum
- Water: ad libitum
- Acclimation period: 1 day followed by 8 days pretreatment).
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71±6
- Humidity (%): ambient
- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.2% Hydroxypropyl methyl cellulose
- Details on oral exposure:
- Method of administration:
Gavage - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of the dosing formulations were sent for assay analysis in weeks 1 and 4 of the test period.
At the end of the treatment period a sample of the bulk test article was sent for analysis to verify stability over the treatment period. - Duration of treatment / exposure:
- Test duration: 28 - 42 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg
Basis:
other: gavage
- Remarks:
- Doses / Concentrations:
15mg/kg
Basis:
other: gavage
- Remarks:
- Doses / Concentrations:
150mg/kg
Basis:
other: gavage
- Remarks:
- Doses / Concentrations:
500mg/kg
Basis:
other: gavage
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 10 animals at 150 mg/kg bw/day
Male: 10 animals at 500 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 10 animals at 150 mg/kg bw/day
Female: 10 animals at 500 mg/kg bw/day
6 males and 10 females in the 500mg/kg/day group were either found dead or euthanized in a moribund condition by day 14. Consequently, the remaining animals in this group were reduced to a daily dosage of 300mg/kg/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on acute oral toxicity testing results
- Rationale for animal assignment: random - Positive control:
- n/a
Examinations
- Observations and examinations performed and frequency:
- All rats observed twice daily during pretreatment, treatment and recovery for survival and general condition.
Physical condition and behavior recorded 1-2 hrs after the daily dose at least 2 days per week during the treatment period and weekly during the recovery period at approx the same time each day.
Formulation of different test concentrations were prepared for each dosage level so that all rats received a constant volume of 10mg/kg with each treatment.
BODY WEIGHT: Yes
- Time schedule for examinations: At least twice during pretreatment and at least twice weekly during treatment and recovery for all rats in the study - Sacrifice and pathology:
- All rats that died during the study were necropsied as soon as practicable. Those that became moribund or deemed unlikely to survive until the next day were euthanized and necropsied.
Up to 5 males and 5 females from each group were fasted overnight, euthanized and necropsied at the end of the treatment and recovery periods.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- On days 6-8, seven rats, 1 male and 6 females, in the 500mg/kg/day dosage group were found dead or were euthanized in a moribund condition.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- On days 6-8, seven rats, 1 male and 6 females, in the 500mg/kg/day dosage group were found dead or were euthanized in a moribund condition.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower mean body weight values were observed (30-35%) in both males and females in 500-300mg/kg group compared to control group.
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No statistically significant difference to control groups among the low and mid dosage groups
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In 500-300mg/kg grp, increses in ALP, ALT and AST activities. Increase in BUN values in some rats also.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No toxicological differences with control group.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- No difference between weights observed at the end of treatment and recovery period. However, marginal incs versus control for mean absolute and relative liver wts (in males and females) on 150mg/kg/day at end of treatment period.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related gross observations were present in the rats that completed the study.
- Details on results:
- CLINICAL SIGNS:
MORTALITY: 6 males and 10 females in the 500mg/kg/day group were either found dead or euthanized in a moribund condition by day 14. Consequently, the remaining animals in this group were reduced to a daily dosage of 300mg/kg/day
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- haematology
- mortality
- organ weights and organ / body weight ratios
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Recovery group animals were only assigned to group T2 after it became apparent that T3 treatment group animals would not survive completion of the treatment period. Since T2 recovery animals were not part of the original assignment to treatment, and these animals began treatment 10 days after the start of treatment for all other study animals it was decided to exclude data from the T2 recovery animals from all statistical an alysis.
Applicant's summary and conclusion
- Conclusions:
- The no-toxic-effect level ws considered to be 15mg base/kg/day in this study.
- Executive summary:
The oral administration of Abbott-88820 at dosages of 150-500mgm/kg/day resulted in severe gaseous distension of the gastrointestinal tract and ultimately death in numerous rats. In surviving animals at a dosage of 150mg/kg/day, signs of toxicity were limited to hepatocellular.
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.