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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
Endpoint summary
Administrative data
Description of key information
study conducted according to OECD test guideline 401, result: not classified (CLP); Category 5 (GHS)
study conducted accoding to OECD test guideline 402, result: not classified
acute toxicity study (i.p. application), result: LD50 2000 - 5000 mg/kg bw (in mice)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Feb. 1987
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Moallegaard Breeding Centre Ltd, Ejby, DK-4623 Ll. Skensved.
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 143-152 g
- Fasting period before study: 18 h
- Housing: The rats were individually ear-tagged and kept in Macrolone cages Type Ill (42 x26 x 15 cm) 2 or 3 to a cage, males and females separated. The bedding was
softwood sawdust "Spanvall Special White" from Spanvall Ltd, Jorlose, DK-M90 Jerslev.
- Diet (e.g. ad libitum): ad libitum; complete rodent diet “Altromin 1314" from Chr. Petersen Ltd, DK-4100 Ringsted
- Water (e.g. ad libitum): ad libitum; drinking watern acidified with hydrochloric acid to pH 2.5
- Acclimation period: None
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/- 2
- Humidity (%): 55+/-15
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.0 mL/100 g bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 1, 3 and 6 hours after administration and thereafter daily for a period of 14 consecutive days. Body weights (b.wt.) were recorded on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- other:
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Since no rats died of the treatment the oral LD50 must exceed 2000 mg "Amino-butane-triol-acetonide"/kg b.wt.
- Executive summary:
In an acute oral toxicity study according to OECD test guideline 401 (1987), groups of fasted, young adult Wistar rats (5/sex) were given a single oral dose of Aminodioxepan (100% a.i.) at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined = > 2000 mg/kg bw
No mortality occurred during this limit test.
Aminodioxepan is of LOW Toxicity based on the LD50 in both males and females.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- guideline study, the quality is expected to be high
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan. 1993 to May 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- 3 animals/ group instead of 5
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1989
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering
- Weight at study initiation: 90-109 g males; 89-105 g females
- Fasting period before study: 19 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): ad libitum; pell. Altromin® R
- Water (e.g. ad libitum): ad libitum, demineralized acidified water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 52-63
IN-LIFE DATES: From: 1993-01-05 To: 1993-01-18 - Type of coverage:
- not specified
- Vehicle:
- physiological saline
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on days 1, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of Aminodioxepan in male and female rats after a single dermal application is > 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study according to Roll, R. et al., Bundesgesundheitsblalt 8/89, 336-340, groups of young adult Wistar rats (3/sex) were dermally exposed to Aminodioxepan (100% a.i) in 0.9% NaCl for 24 hours at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined => 2000 mg/kg bw
No mortality occurred in this limit test.
Aminodioxepan is of LOW Toxicity based on the LD50 in male and female Wistar rats.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- guideline study, the quality is expected to be high
Additional information
In an acute oral toxicity study according to OECD test guideline 401 (1987), groups of fasted, young adult Wistar rats (5/sex) were given a single oral dose of Aminodioxepan (100% a.i.) at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined = > 2000 mg/kg bw
No mortality occurred during this limit test.
Aminodioxepan is of LOW Toxicity based on the LD50 in both males and females.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
In an acute dermal toxicity study according to Roll, R. et al., Bundesgesundheitsblalt 8/89, 336-340, groups of young adult Wistar rats (3/sex) were dermally exposed to Aminodioxepan (100% a.i) in 0.9% NaCl for 24 hours at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined => 2000 mg/kg bw
No mortality occurred in this limit test.
Aminodioxepan is of LOW Toxicity based on the LD50 in male and female Wistar rats.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
In an acute toxicity study in male NMRI mice Aminodioxepan was administred once intraperitoneally at the doses of 100. 250, 500, 1000, 2000, and 5000 mg/kg bw. The animals were observed for 14 days. At the first three doses none of the animals showed any toxicologically relevant signs. Animals of the 1000 and 2000 mg/kg group showed signs like apathy (slight to moderate) and eyelid closure (incomplete or complete) within the first two days. At day 2-14 these animals were without findings. In the high dose group animals showed severe apathy, prone position, vocalisation, gait gasping breathing and complete eyelid closure. All animals of these group died within one day. Based one these results the LD50 for i.p. application in mice was determined between 2000 and 5000 mg/kg bw.
Justification for classification or non-classification
Based on the available data, Aminodioxepan is not classified as acutely toxic by oral and dermal route according to Regulation (EC) No.1272/2008 (CLP).
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