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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Beckley, J.H.; Comparative eye testing: Man vs. animal. Toxicol. Appl. Pharmacol. 7, 93- 101, 1965
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Weight at study initiation: male: 3.5 kg; females: not weighed at the start of the study; at the end of the test: 4.6 kg
- Housing: individually under conventional conditions in metal cages
- Diet (e.g. ad libitum): ad libitum; pell. Altromin® K
- Water (e.g. ad libitum): ad libitum; demineralized water and acidificed water
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%):54-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg/eye - Observation period (in vivo):
- 11 days
- Number of animals or in vitro replicates:
- 1 males and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM: according to the score system in the "lllustrated Guide for Grading Eye Irritation by Hazardous Substances“, U.S. Department of Health, Education and Welfare, Food and Drug Administration, Washington D.C. 20204, USA.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.55
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9-11d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
Evaluation of the local tolerance of the test item on the rabbit conjunctiva after a single application according to the score system in the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances", U.S. Department of Health, Education and Welfare, Food and Drug Administration Washington D. C. 20204, USA
Animal number/sex |
|
| Hours after application | Results | ||
24 | 48 | 72 | ||||
851M | Cornea |
| 0 | 0 | 0 | + |
Iris |
| 0 | 0 | 0 | ||
Conjunctiva | Reddening | 2+ | 2+ | 2+ | ||
| swelling | 3+ | 0 | 0 | ||
808 F | Cornea |
| 0 | 0 | 0 | + |
Iris |
| 0 | 0 | 0 | ||
Conjunctiva | Reddening | 3+ | 2+ | 2+ | ||
| swelling | 1 | 0 | 0 | ||
772F | Cornea |
| 0 | 0 | 0 | + |
Iris |
| 0 | 0 | 0 | ||
Conjunctiva | Reddening | 3+ | 2+ | 2+ | ||
| swelling | 1 | 0 | 0 |
Findings | Right eye | Left eye | |
100 mg test item/eye (one male, two females) | untreated | ||
A/B | (x-y) | ||
Outer eyelids |
|
| Without findings |
Secretion with wettening of surrounding fur |
|
| |
Slight | 3/2 | (1-2) | |
Moderate | 3/3 | (1-2) | |
severe | 5/3 | (1-1) | |
Swelling of the margin of eyelids |
|
| |
Slight | 2/1 | (2-3) | |
Reddening of the skin of eyelids |
|
| |
Slight | 6/2 | (1-3) | |
Moderate | 3/2 | (1-1) | |
Complete eyelid closure | 3/3 | (1-2) | |
Incomplete eye lid closure | 5/3 | (1-2) | |
Conjunctiva palpebrae superior et inferior |
|
| |
Hematomas (conj. Inferior) |
|
| |
Slight (Ø 1 mm) | 2/2 | (5-10) | |
Moderate (Ø 2 mm) | 2/1 | (8-9) | |
Severe (Ø 3 mm) | 9/1 | (1-7) | |
Reddening |
|
| |
Slight | 9/3 | (5-8) | |
Moderate | 12/3 | (1-4) | |
severe | 6/3 | (1-2) | |
Swelling |
|
| |
Slight | 2/2 | (2-2) | |
moderate | 8/3 | (1-1) | |
Injection of blood vessels |
|
| |
Slight | 1/1 | (1-1) | |
Moderate | 11/3 | (1-6) | |
Membrana nicitans |
|
| |
Reddening |
|
| |
Slight | 20/3 | (1-10) | |
Moderate | 4/3 | (2-3) | |
Swelling |
|
| |
Slight | 4/3 | (1-2) | |
moderate | 8/3 | (1-1) | |
Injection of blood vessels |
|
| |
Slight | 6/3 | (1-9) | |
Moderate | 16/3 | (2-8) | |
Severe | 1/1 | (2-2) | |
Conjuntiva sclerae |
|
| |
No details visible due to swellings of conjunctiva palpebrae | 6/3 | (1-1) | |
Reddening |
|
| |
Slight | 2/1 | (1-1) | |
Injection of blood vessels |
|
| |
Slight | 2/1 | (1-1) | |
moderate | 1/1 | (1-1) | |
A=summation of positive findings B=number of animals concerned X=first day of occurrence of a finding Y= last day of the occurrence of a finding |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- According to the score system in the "Illustrated Guide for Grading Eye Irritation by hazardous Substances“ all animals reacted positively.
- Executive summary:
In a primary eye irritation study similar to OECD test guideline 405, 100 mg of Aminodioxepan (100% a.i.) was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits, one male and two females. Animals then were observed for 11 days. Irritation was scored by the method cited in the "lllustrated Guide for Grading Eye Irritation by Hazardous Substances“, U.S. Department of Health, Education and Welfare, Food and Drug Administration, Washington D.C. 20204, USA.
On the day of application, severe secretions, wettening of the external skin of the eyelids, reddenings of the eyelids (slight to moderate) and conjunctivae (moderate to severe), swellings of the conjunctivae (moderate) as well as vascular injections of the conjunctivae and eyelid closure occurred in all animals. From the second or third day onwards the majority of the findings, with the exception of the conjunctival vascular injections (mainly moderate up to day 6 or 8, respectively), gradually faded away. In addition, a hemorrhage was observed in 2 animals starting on day 1 or day’ 5, respectively (maximally 3 mm e) in the conjunctiva inferior (identified in table 2 as hematoma). Only one animal had a swelling of the eyelid margin on days 2 and 3 (slight). The animals were free of findings from day 11 (nos. 772F, 851M) and day 9 (no. 808F) onwards.
The control eyes were without findings. In this study, Aminodioxepan is moderately irritating to the eye based on the classification by Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) Category 2 (irritating to eyes).
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