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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-06-04 till 2008-06-13
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 14 weeks (male), 15-16 weeks (females)
- Weight at study initiation: 2600 g (male), 2503 g and 2819 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum.
- Acclimation period: 2008-06-04 to 2008-06-08
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: closely clipped
- Vehicle:
- other: moistened with purified water
- Controls:
- other: control area on same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal
VEHICLE
- Purity: purified water - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 1, 24, 48 and 72 hours after exposure
- Number of animals:
- 3 (one male, two females)
- Details on study design:
- TEST SITE
- Area of exposure: left flank (10 cm x 10 cm)
- % coverage: ca. 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water (after dressing removal)
- Time after start of exposure: 4 hrs
SCORING SYSTEM: numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 0 |
Max. score: 0 |
|
60 min |
0/0/0 |
0/1/1 |
24 h |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
Reversibility*) |
- |
- |
Average time (unit) for reversion |
- |
- |
*) Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria of the Commission Directive 2001/59/EC of August 2001, Hostavin N 20 - Hydrochlorid is considered to be “not irritating” to rabbit skin.
- Executive summary:
The irritation potential to skin was investigated acc. to OECD guideline 404 in rabbits.
The test item was applied by topical semi-occlusive application to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. No abnormal findings were observed on the treated skin of any animal. No staining produced by the test item of the treated skin was observed. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. The male did not gain weight from the day of treatment to the last day of observation. The body weights of all rabbits were considered to be within the normal range of variability.
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