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EC number: 277-620-5 | CAS number: 73833-37-1
- 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:
- 2008-06-04 till 2008-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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:
- yes
Test material
- Reference substance name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride
- EC Number:
- 277-620-5
- EC Name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride
- Cas Number:
- 73833-37-1
- Molecular formula:
- C22H40N2O2.xClH
- IUPAC Name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride
- Physical state: solid, white
- Analytical purity: => 99%
- Lot/batch No.: DEF2036584
- Expiration date of the lot/batch: 2018-05-08
- Stability under test conditions: stable
- Storage condition of test material: At room temperature (range of 20 ± 5 °C), light protected.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd
- Age at study initiation: 11 weeks
- Weight at study initiation: 172.8 g to 193.8 g
- Fasting period before study: fasted for approximately 17 to 18 hours (access to water was permitted). Food was provided again approximately 3
hours after dosing.
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, at libidum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum.
- Acclimation period:
04-JUN-2008 to 10-JUN-2008 (females, 2000 mg/kg)
06-JUN-2008 to 12-JUN-2008 (females, 2000 mg/kg)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g substance/mL vehicle
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle.
- Lot/batch no. (if required): 1310049
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): prior to dosing
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no justification (no datat available) - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females at 2000 mg/kg bw
3 females at 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 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 and twice daily during days 2-15.
Body Weights On test days 1, 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.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: On test day 6, the three females of the first group were found with delayed clinical signs, such as slight sedation which persisted up to test day 14. A slighty ruffled fur was noted in the three females 6 or 7 days post treatment and persisted up to tes
- Gross pathology:
- One female was found with an enlarged uterus with gray-white contents and another female was found with a light-brown discolorated liver at
necropsy. Otherwise, no macroscopic findings were recorded at necropsy. - Other findings:
- Histopathology: A minimal focal acute inflammation was recorded in the submucosa of the glandular stomach of one female of group 2. Based on its severity and distribution and on the absence of any other degenerative changes, this lesion was considered to be most likely incidental.
Any other information on results incl. tables
Table 1: Animal assignment
Dose (mg/kg bw) |
Males |
Females |
Combined |
2000 |
- |
3 |
- |
2000 |
- |
3 |
- |
Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]
Dose |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity (#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
- |
0 |
- |
- |
- |
0 |
- |
2000 | - | 0 | - | - | - | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 67/548/EEC: no classification warranted
1272/2008/EC: no classification warranted - Executive summary:
The acute toxicity by oral application (gavage) was investigated according to OECD guideline 423 .
Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.
All animals survived until the end of the study period. Some clinical signs were recorded in both groups.
One female was found with an enlarged uterus with gray-white contents and another female was found with a light-brown discolorated liver at necropsy. Otherwise, no macroscopic findings were recorded at necropsy.
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