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EC number: 419-050-3 | CAS number: 79944-37-9 AMINODIOXEPAN
- 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:
- 1986-06-19 to 1986-08-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
- EC Number:
- 419-050-3
- EC Name:
- trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
- Cas Number:
- 79944-37-9
- Molecular formula:
- C7H15NO3
- IUPAC Name:
- 6-amino-2,2-dimethyl-1,3-dioxepan-5-ol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Weight at study initiation: 2.5-2.9 kg (males and females)
- Housing: individually under conventional conditions in metal cages
- Diet (e.g. ad libitum): ad libitum; pellet. Altromin K
- Water (e.g. ad libitum): ad libitum; demineralized water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 40-56
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with aqua bidist.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 4 days
- Number of animals:
- 2/sex/group
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Both sites (treated and untreated) were covered with a piece of gauze (semiocclusive) fixed on the skin with Leukoflex(R).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure the gauze was removed and the treated and untreated skin areas were wiped off carefully with luke warm tap water and cotton wool.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
30-60 min after exposure and thereafter every 24 h until day 4
SCORING SYSTEM: according to Draize et al.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.19
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1d
- Irritant / corrosive response data:
- After a single dermal application of ZK 38.199 on the intact skin of the rabbit transient slight reddening was observed in two animals on application day. The irritation index according to Draize was 0.19, indicating slight irritation. The irritation was reversible within the first day.
Any other information on results incl. tables
Local findings
Findings | Right side (treated with test item) | Left side untreated | |
| A | (B) | Without findings |
Very slight reddening of the area of administration | 1/1 | (1-1) | |
Patchy slight reddening | 1/1 | (1-1) | |
Without findings | 14/4 | (1-4) | |
A = summation of positive findings/number of animals concerned (B) = (first — last day of occurrence of a finding) [within the first hour] |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The above mentioned transient finding after a single application of Aminodioxepan on the intact skin of the rabbit was classified as a very slight negligible incompatibility reaction. Thus, the substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
In a primary dermal irritation study similar to OECD test guideline 401, young adult Wistar rats (2/sex) were dermally exposed to 2000 mg/kg bw of Aminodioxepan (100 % a.i.) moistened with water for 4 hours. Animals then were observed for 4 days. Irritation was scored by the method of Draize et al..
The only local finding after treatment with the test item was slight transient reddening of the skin in 2/4 animals on day 1 of the test. The irritation index according to Draize was 0.19, indicating slight local irritation.
Thus, in this study, Aminodioxepan is not a dermal irritant.
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