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EC number: 204-877-2 | CAS number: 128-08-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 June 1995 to 18 September 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP .
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, B.1. "Acute Toxicity-Oral", July 31, 1992.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-bromosuccinimide
- EC Number:
- 204-877-2
- EC Name:
- N-bromosuccinimide
- Cas Number:
- 128-08-5
- Molecular formula:
- C4H4BrNO2
- IUPAC Name:
- 1-bromopyrrolidine-2,5-dione
- Reference substance name:
- N-BROMSUCCINIMID
- IUPAC Name:
- N-BROMSUCCINIMID
- Details on test material:
- - Identification: N-Bromsuccinimid
- Description: White solid
- Batch no.: SHEN 009
- Purity/Formulation: 100%
- Stability of Test Article: Stable under storage conditions; for 1 year as from sponsor' s signature date on data sheet.
- Stability of test Article in Vehicle: Stable in water for 2 hours.
- Storage conditions: In the original container at room temperature away from direct sunlight.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd.; Wölferstrasse 4, 4414 Füllingsdorf/Switzerland
- Age at study initiation: male: 8 weeks, females: 10 weeks
- Weight at study initiation: males: 195.9 - 218.5 g; females: 175.0 - 187.1 g
- Fasting period before study: approximately 16h
- Housing: Makrolon type 4 with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet: Pellet standard Kliba 343, Batch no. 86/95 rat maintenance diet, ad libitum
- Water: Tap water from Füllingsdorf, ad libitum
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24°C
- Humidity (%): 48 to 90 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 artificial fluorescent light (approx. 100 Lux)
:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test article was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a homogenizer (Ultra Turax, Janke & Kunkel, D-79219 Staufen). The preparation was made shortly before dosing. The animals received a single dose of the test article on a mg/kg bw basis by oral gavage following fasting for approx. 16 hours, but with free access to water. Food was provided again approx. 3 hours after dosing.
Application Volume: 10 ml/kg - Doses:
- 1000 mg/kg bw (Group 1)
2000 mg/kg bw (Group 2) - No. of animals per sex per dose:
- 5 males and 5 females: 1000 mg/kg bw (Group 1)
5 males and 5 females: 2000 mg/kg bw (Group 2) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: each animal was examined for changes in appearance and behaviour four times during day 1 and once daily for surviving animals during days 2-15. weighing: day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights - Statistics:
- not applicable
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In group one (1000 mg/kg bw) no deaths occurred . In group 2 (2000 mg/kg bw) one male died one hour after treatment with the test article, two males died on test day 2 and 3 respectively, and one female died on test day 12.
For further details please see also the attached background material: '1995.Pfister.acute oral toxicity study with N-Bromosuccinimide in rats_ tables and appendices.pdf'. - Clinical signs:
- other: Group 1 (1000 mg/kg bw): sedation (5/5)* ruffled fur (5/5) Group 2 (2000 mg/kg bw) sedation (4/5), ruffled fur (4/5), hunched posture (2/5), ventral and lateral recumbency (1/0), dyspnoea (5/5), diarrhea (0/1), emaciation (3/5). * ( / ) = number of male
- Gross pathology:
- Group 1 (1000 mg/kg bw): no findings.
Group 2 (2000 mg/kg bw): scheduled necropsy: no findings; spontaneous death: ileum distended with gas (1/0)*, reddish discoloration of stomach (1/0), hemorrhagic-water fluid in body cavities (1/0), yellowish liquid in stomach (0/1)
* ( / ) = number of male/female animals.
For further details please see also the attached background material: '1995.Pfister.acute oral toxicity study with N-Bromosuccinimide in rats_ tables and appendices.pdf'. - Other findings:
- For further details please see also the attached background material: '1995.Pfister.acute oral toxicity study with N-Bromosuccinimide in rats_ tables and appendices.pdf'.
Any other information on results incl. tables
For further details please see also the attached background material: '1995.Pfister.acute oral toxicity study with N-Bromosuccinimide in rats_ tables and appendices.pdf'.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of N-bromosuccinimide is > 2000 mg/kg bw in rats.
- Executive summary:
N- bromosuccinimide was administered to two groups of 5 male and female by oral gavage at single doses of 1000 and 2000 mg/kg bw.
In group one (1000 mg/kg bw) no deaths occurred in group two (2000mg/kg bw) one male died one hour after treatment with the test substance, two males died on test day 2 and 3 respectively, and one female died on test day 12.
Based on these observations, the LD50 estimation for acute oral toxicity in rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg bw.
Therefore no classification is required according to DSD and CLP.
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