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EC number: 241-158-2 | CAS number: 17091-31-5
- 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
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:
- 01/2008 to 03/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 07072601
- Expiration date of the lot/batch: 26.07.2008 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 189 to 209 g
- Fasting period before study: yes
- Housing: solid-bottomed clear polycarbonate cages with a stainless steel mesh lid
- Water (e.g. ad libitum): tap-water from public distribution system
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 36 to 57
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg body weight
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: D2, D7, and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- not observed
- Clinical signs:
- It was registered in the treated animals, from thirty minutes after the test item administration, a decrease of the spontaneous activity (6/6) associated with a decrease of the righting reflex (4/6) and a piloerection (6/6). 48 hours after the test item administration, no clinical signs related to the test item administration were noted.
- Body weight:
- It was noted an absence of the body weight gain in the treated animals, 48 hours after the test item administration. Then the body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item Bromo(hexahydro-2H-azepin-2-onato-N)magnesium is higher than 2000 mg/kg body weight by oral route in the rat, in accordance with the OECD guideline n°423.
A classification according to (EU) No. 1272/2008 is not required based on this data. - Executive summary:
The LD50 of the test item Bromo(hexahydro-2H-azepin-2-onato-N)magnesium is higher than 2000 mg/kg body weight by oral route in the rat, in accordance with the OECD guideline n°423.
A classification according to (EU) No. 1272/2008 is not required based on this data.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- satisfying
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- LC50
- Value:
- 1 500 mg/m³
- Quality of whole database:
- Acceptable.
The LC50 is estimated from the lowest LC50 of epsilon-Caprolactam resulting in an ATE =1.5.
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:
- 02/2008 to 05/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 07072601
- Expiration date of the lot/batch: 26.07.2008
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Females (if applicable) nulliparous and non-pregnant: no
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 213 g to 238 g (males) and 203 g to 221 g (females)
- Housing: solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; during the treatment, the animals were kept in an individual cage. At day 3, the animals were put into their cage by 2 or 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 22°C
- Humidity (%): 34 % to 52 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- 2.000 mg/kg bw
- No. of animals per sex per dose:
- 5 male
5 female - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on day 2, 7 and 14.
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- not observed
- Clinical signs:
- none
- Body weight:
- normal weight evolution
- Gross pathology:
- no reveal treatment-related changes
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No need for classificaton as "acute Tox." according to (EU) No. 1272/2008.
- Executive summary:
The LD50 of the test item Bromo(hexahydro-2H-azepin-2-onato-N)magnesium is higher than 2,000 mg/kg body weight by dermal route in the rat.
No signs for skin corrosion or irritation.
Reference
Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- satisfying
Additional information
Justification for classification or non-classification
Oral route:
Bromo(hexahydro-2H-azepin-2-onato-N)magnesium is not classified into the hazard category "Acute Tox, oral", due to an LD50(oral) > 2000 mg/kg bw.
Dermal route:
Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium is not classified into the hazard category "Acute Tox, dermal", due to an LD50(oral) > 2000 mg/kg bw.
Inhalative route:
A test on the inhalative toxicity of Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium is not available. However, the substance hydrolyses under physiological conditions with the formation of epsilon-Caprolactam and basic magnesium bromide. Therefore also the effects of epsilon-caprolactame have to be taken into consideration. Epsilon-caprolactame is harmonised classified into "Acute Tox, inhalativ", category 4, H332, which corresponds to an ATE value of 1.5 mg/l (dust). Thus, Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium is classified into the hazard category "Acute Tox, inhalative", category 4, due to the presence of up to 80% epsilon-caprolactame as a stabiliser. As an estimation, the
ATE value of Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium is considered to have the same value as epsilon-Caprolactam.
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