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EC number: 604-604-0 | CAS number: 147770-06-7
- 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:
- January 10-27, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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 (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-Ethoxy-4-{3-[(S)-3-methy-1-(2-piperidin-1-yl-phenyl)-butylamino]-2-oxo-propyl}-benzoic acid ethyl ester
- EC Number:
- 604-604-0
- Cas Number:
- 147770-06-7
- Molecular formula:
- C29 H40 N2 O4
- IUPAC Name:
- 2-Ethoxy-4-{3-[(S)-3-methy-1-(2-piperidin-1-yl-phenyl)-butylamino]-2-oxo-propyl}-benzoic acid ethyl ester
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Hsd:Wistar rats (HsdBrl:WH,Full-Barrier), Sex: male and female, body
weight at the commencement of the study: female 149 - 167 g and male 150
- 167 g. 3 male and 3 female animals were used.
The animals were derived from a controlled full barrier maintained breeding
system (spf).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals
were bred for experimental purposes.
The animals were barrier maintained (semi-barrier) in air conditioned rooms
- Temperature: 22 ± 3° C
- Rel. humidity: 55 ± 10%
- Artificial light, lighting regime 12: 12 hours, light 6.00 - 18.00
- Air change: 10 x / hour
- Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice,
totally-pathogen-free-TPF
- Free access to tap water ( drinking water, municipal residue control,
microbial. controlled periodically)
- The animals were individually kept in Macrolon cages on Altromin saw fiber
bedding
- Acclimatization period: 1 week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg: 3 males/3 females
- Control animals:
- no
- Details on study design:
- The starting dose was 2000 mg/kg body weight. Since no presence of compound-
related mortality of the animals was observed no further testing was
required.
Animals were observed for 14 days after dosing.
The animals were weighed prior to first application and once a week thereafter.
A careful clinical examination was made twice a day on the day of dosing
and once a day thereafter.
Cageside observations included changes in the skin and fur, eyes and mucous
membranes. Also respiratory, circulatory, autonomic and central nervous
systems and somatomotor activity and behaviour pattern were examined.
Particular attention was directed to observations of tremor, convulsions,
salivation, diarrhoea, lethargy, sleep and coma.
At the end of the observation period the animals were sacrified by an overdosage
of pentobarbital.
All animals were subjected to gross necropsy. All gross pathological changes
were recorded.
Individual reactions of each animal were recorded at each observation time.
Toxic response data were recorded by sex and dose level.
Nature, severity and duration of clinical observations were described.
Body weight changes were summarized in tabular form.
Necropsy findings were described.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The oral application of the test item in a dose of 2000 mg/kg BW caused no
compound related mortalities. - Clinical signs:
- other: No clinical signs of toxicity were observed throughout the observation period.
- Gross pathology:
- Necropsy revealed an acute injection of blood vessels in all animals in the
abdominal region. This finding is due to euthanasia with an overdose of
pentobarbital injected intraperitoneally.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. to CLP
- Conclusions:
- Considering the reported data of this toxicity test it can be stated that the test
item AGEE 623 AMIDESTER has no acute toxic characteristics.
The LD50 was determined to be > 2000 mg/kg BW. - Executive summary:
The test item AGEE 623 AMID ESTER was given in a dose of 2000 mg/kg
body weight to two groups of 3 male and 3 female rats (HsdBrl: WH Wistar)
in a single exposure via oral gavage.
A careful clinical examination was made once a day. At the end of the observation
period the animals were sacrificed and necropsy was carried out to
record gross pathological changes.
A maximum dosage of 2000 mg/kg BW according to the acute toxic class
method regime, caused no compound related mortality within 14 days p.
appl.. No clinical signs of toxicity were observed throughout the observation
period.
Therefore, according to OECD guideline 423, a sufficient estimation of the
acute oral toxicity of the test item AGEE 623 AMID ESTER is provided.
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