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EC number: 200-143-0 | CAS number: 52-51-7
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in accordance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Bronopol
- EC Number:
- 200-143-0
- EC Name:
- Bronopol
- Cas Number:
- 52-51-7
- Molecular formula:
- C3H6BrNO4
- IUPAC Name:
- 2-bromo-2-nitropropane-1,3-diol
- Test material form:
- solid: crystalline
- Details on test material:
- Purity 99.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult animals
(male animals approx. 8 - 16 weeks
female animals approx. 9 - 16 weeks)
Animal weights at start of Animals of comparable weight (200 g - 300 g ± 20% of the the study: mean weight)
Source: Charles River Laboratories, Sulzfeld, Germany
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Tylose CB 30.000
- Details on dermal exposure:
- The test substance was prepared in 0.5% aqueous Tylose® and was applied to a skin area of about 50 cm2 (10% of body surface) under semi occlusive conditions for 24 hours.The test substance concentration in the vehicle was 80g/100 ml (w/v) and the application volume was 2.5 ml/kg
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Five male and five female Wistar rats were treated with 2000 mg/kg bw test substance.The test substance was prepared in 0.5% aqueous Tylose® and was applied to a skin area of about 50 cm2 under semi-occlusive conditions for 24 hours.The test substance concentration in the vehicle was 80g/100 ml (w/v) and the application volume was 2.5 ml/kg. After 24 hours of exposure the treated skin was cleaned with water. The animals were checked for mortality twice each working day and once on Saturday, Sundays or holidays. They were observed for clinical symptoms of toxicity several times on the day of treatment and once daily thereafter. Body weights were recorded prior test start, weekly thereafter, and at the end of the observation period. The skin was examined 30 to 60 minutes following removal of the dressing, weekly thereafter, and at the end of the observation period. All rats that died and the surviving rats at the end of the study (18 days observation period) were subjected to necropsy and examined for gross pathology.Analytical determinations of the test substance preparation with respect to stability in the vehicle were performed prior to starting the toxicological study.
The assessment of skin findings was based on Draize JH (Appraisal of the safety of chemicals in food, drugs and cosmetics. The association of food and drug officials of the United States Austin, Texas, 1959). - Statistics:
- Binomial test according to SNEDECOR GW (“Statistical methods”, 8th ed., Iowa State University Press/Ames, 1989).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No mortality occurred
- Mortality:
- No mortality occurred
- Clinical signs:
- other: The animals of both sexes displayed poor general state, dyspnoea and apathy as clinical symptoms; these symptoms lasted until day 1 of observation.Local effects at the application sites were seen in both, males and females and included white discoloration
- Gross pathology:
- Excepted for incrustation and full thickness necrosis seen at the application site in 4/5 males and 5/5 females, pathological examination at necropsy revealed no further abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (males+females) was determined as >2000 mg/kg bw (no mortlity occured).
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