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EC number: 249-984-5 | CAS number: 29976-53-2
- 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:
- 2006-04-26 to 2006-05-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl 4-oxopiperidine-1-carboxylate
- EC Number:
- 249-984-5
- EC Name:
- Ethyl 4-oxopiperidine-1-carboxylate
- Cas Number:
- 29976-53-2
- Molecular formula:
- C8H13NO3
- IUPAC Name:
- ethyl 4-oxopiperidine-1-carboxylate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-126971-AAA (T000509)
- Physical state: liquid
- Appearance: clear colourless to light yellow liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 9 female Wistar rats, HanRcc: WIST (SPF); RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf, Switzerland
- Age when treated: 12-13 weeks
- Weight at treatment (day 1): 178.0 - 190.7 grams (females, 2000 mg/kg), 170.1 - 174.6 grams (females, 300 mg/kg), 173.4 - 190.3 grams (females, 300 mg/kg)
- Fasting period before study: no data
- Housing: Standard Laboratory Conditions, in groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz, Switzerland).
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 001/06 (Provimi Kliba AG, CH-4303 Kaiseraugst, Switzerland) ad libitum. Analysis of contaminants performed.
- Water (e.g. ad libitum): community tap water from Füllinsdorf ad libitum. Bacteriological, chemical and contaminant analysis performed.
- Acclimation period: one week (2006-04-26 to 2006-05-02 for females, 2000 mg/kg; 2006-04-28 to 2006-05-04 for females, 300 mg/kg; 2006-05-05 to 2006-05-11 for females, 300 mg/kg), under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3°C
- Humidity (%): 30-70% (values above 70% during cleaning process possible)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, music during the daytime light period.
IN-LIFE DATES:
- Females, 2000 mg/kg: from: 2006-05-03 to: 2006-05-17
- Females, 300 mg/kg: from: 2006-05-05 to: 2006-05-19
- Females, 300 mg/kg: from: 2006-05-12 to: 2006-05-26
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0,03 and 0,2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This formulation trial is excluded from the GLP statement of compliance.
- Lot/batch no. (if required): 1204719
- Expiry date: 2007-02
- Decription: colourless viscous liquid
- Source: FLUKA Chemie GmbH, CH-9471 Buchs
- Stability of vehicle: stable under storage conditions
- Storage conditions: at room temperature (range of 20 +/- 5°C), light protected
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION (if unusual):
- The dose formulations were made shortly before each dosing occasion using a magnetic stirrer as homogenizer.
- The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The glass beaker was wrapped with aluminium foil to protect the test item solution against light.
- Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 300 and 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 females per group; 3 groups
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: mortality/viability: daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15; body weights: on test days 1 (prior to administration), 8 and 15; clinical signs: daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy of deaths: as soon as they were killed for ethical reason. The two animals which were killed approximately 3 hours and 2 days respectively after test item administration were killed by an intraperitoneal injection of 1:1 (v/v) mixture of Eutha ® 77 (containing 400 mg pentobarbitalum natricum) and physiological saline at a dose of at least 2.0 ml/kg body weight.
- Necropsy of survivors performed: yes, all surviving animals were killed at the end of the observation period by carbon dioxide asphyxation and discarded after macroscopic examinations were performed. No organs or tissues were retained. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two of three animals treated with 2000 mg/kg had to be killed for ethical reasons 3 hours and 2 days after application respectively. One of the 2000 mg/kg and all the 300 mg/kg treated animals survived until the end of the study.
2000 mg/kg: 2/3
300 mg/kg: 0/3
300 mg/kg: 0/3 - Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Gross pathology:
- One of the 2000 mg/kg treated animal, which had to be killed in extremis on test day 2, showed a stomach, duodenum, jejunum and ileum filled with liquid contents. In addition the kidneys were light brown and discolored and the urine bladder was distended and filled with urine. The other sacrificed animal showed a light brown discoloration of the kidney and a stomach filled with liquid contents. The 300 mg/kg treated animals and the surviving 2000 mg/kg treated animal showed no macroscopic findings at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The median lethal dose of T000509 after single oral administration to female rats, observed over a period of 14 days is:
300 mg/kg body weight < LD50 (female rat)< 2000 mg/kg body weight. Based on GHS criteria, T000509 is a Category 4 for Acute Oral Toxicity in rats.
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