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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
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 01/2008 to 03/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- 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
FORM AS APPLIED IN THE TEST (if different from that of starting material): powder - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste F40260 Linxe)
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.24 to 2.99 kg
- Housing: individual boxes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 39 to 57
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 9 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
Chemosis (A): 0 to 4 credits
Discharge (B): 0 to 3 creditis
Redness (C): 0 to 3 creditis
Iris (D): 0 to 2 creditis
Cornea; degree of opacity: 0 to 4 creditis
Cornea: extent of opacity: 1 to 4 creditis
TOOL USED TO ASSESS SCORE: visual - Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 1
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.4
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.7
- Max. score:
- 2
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between D8 and D9, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D7 and D9,
- at the corneal level: a slight to moderate opacity, registered 1 hour after the test item instillation and totally reversible between D3 and D4,
- at the iris level: a congestion registered 24 hours after the test item instillation in one animal and between D 1 and D2 in two other animals.
Moreover, it was noted a corneal neo-vascularisation at D2, in one animal. - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In accordance with regulation (EC) No. 1272/2008, the test item needs to be classified into the hazard class "serious eye damage / eye irritation", category 2, H319.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Skin corrosion / skin irritation:
Classification according to the CLP-regulation as "Skin Irrit. 2":
Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium hydrolyses under physiological conditions with the formation of epsilon-Caprolactam and basic magnesium bromide. Additionally, epsilon-caprolactame is contained up to 80% in the substance as a stabiliser. Therefore also the effects of epsilon-caprolactame have to be taken into consideration. Epsilon-caprolactame is harmonised classified into "Skin Irrit.", category 2, H315. Thus, Bromo(hexahydro-2H-azepin-2 -onato-N)magnesium is classified into the hazard category "Skin Irrit.", category 2, H315, too.
Eye irritation:
Classified according to the CLP-regulation as "Eye Irrit. 2" on the basis of in-vivo test data.
Inhalative irritation:
A test on the inhalative toxicity / inhalative irritation 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. Since epsilon-Caprolactam is classifed as "STOT SE 3", H335, Bromo(hexahydro-2H-azepin-2-onato-N)magnesium will be classified correspondingly.
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