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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 similar to OECD test guideline 404, result: not classified
study conducted similar to OECD test guideline 405, result: Category 2, eye irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- GLP compliance:
- yes
- 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
- 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. - 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.
- 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.
Reference
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] |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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.
- 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
- 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).
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
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).
Justification for classification or non-classification
Based on the available data, Aminodioxepan is not classified as skin irritant and classified as eye irritant Category 2 according to Regulation (EC) No. 1272/2008 (CLP).
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