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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 July 2001 - 25 September 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Acute Oral Toxicity Study, 2000
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Fischer 344 rats obtained from Charles River Laboratories Inc. (Raleigh, North Carolina) and weighing 102-245 grams at study start were used for this study. Rats were born on May 7, 2001 or June 11, 2001. The rats were dosed on July 17, 18, 24, 31, or August 2, 8, 2001 and were sent to necropsy on August 1, 7, 14, 16, or 22, 2001. Animal care facilities are fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International. Upon arrival at the laboratory, the rats were examined for health status by the laboratory veterinarian. Animals were housed two or three per cage in stainless steel cages in rooms that were designed to maintain adequate environmental conditions concerning temperature, humidity, photocycle, and air exchanges. The relative humidity and room temperature were maintained within a range of 40-70% and 22 ± 3 °C, respectively. A 12-hour light/dark photocycle was maintained for all animal rooms with lights on at 6:00 a.m. and off at 6:00 p.m. Room air was exchanged approximately 12-15 times/hour, and the water lines automatically bled every six hours.
Animals were provided LabDiet Certified Rodent Diet #5002 (PMI Nutrition International, St. Louis, Missouri) in pelleted form. Feed and municipal water were provided ad libitum. Analysis of the feed was performed by PMI Nutrition International to confirm the nutritional adequacy of the diet and to quantify the levels of selected contaminants. Drinking water obtained from the municipal water source was periodically analyzed for chemical parameters and biological contaminants by the municipal water department. In addition, specific analyses for chemical contaminants were conducted at periodic intervals by an independent testing facility. Copies of these analyses are maintained at Toxicology & Environmental Research and Consulting, The Dow Chemical Company, Midland Michigan. Animals were acclimated to the laboratory environment for at least one-week prior to study start. Animals were identified via a code number transmitted by a subcutaneously implanted transponder.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Five male rats per dose level received 100, 200, or 300 mg of Bronopol per kg body weight as a 2%, 4%, or 6% mixture in distilled water by single dose gavage. Five female rats per dose level also received 100, 150, or 200 mg of the test material per kg body weight as a 2%, 3%, or 4% mixture in distilled water by single dose gavage. Rats were fasted the night prior to treatment. Feed was provided to all rats immediately following administration of the test material.
- Doses:
- Males: 100, 200, 300 mg/kg bw
Females: 100, 150, 200 mg/kg bw - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- A Detailed Clinical Observation (DCO) was conducted for all rats prior to test material administration for comparison with the observations recorded throughout the study. Animals were observed a minimum of two times on the day of treatment. A DCO was done each day (including weekends and holidays) during the study. Hand-held and open-field observations included a careful physical examination according to an established format. For scored DCOs only observations other than typically expected were recorded. Observations were dictionary based, and the dictionary contained most of the common physical and neurologic abnormalities seen in toxicity studies. Since not all potential observations were contained in the dictionary, free-field descriptions also were allowed. Each animal was weighed, pre-study, the day of treatment, and on test days 2, 8, and 15. A necropsy was performed on all animals.
Animals submitted alive for necropsy were anesthetized by inhalation of carbon dioxide and were euthanized by decapitation after clamping of the trachea. A complete necropsy was conducted on all animals by a veterinary pathologist assisted by a team of trained individuals. The eyes were examined in situ using a moistened glass microscope slide applied to the corneal surface. Following inspection of the externum and body orifices, the nasal, cranial, oral, thoracic, and abdominal cavities were opened and the visceral organs were examined both in situ and following dissection, and tissues were not saved. - Statistics:
- Means and standard deviations were calculated for body weights. The data were evaluated for statistical outliers by a sequential test (Grubbs, 1969); however, outliers were not routinely excluded from statistical analysis. An approximate LD50 was calculated by linear interpolation of the arc sine transformed data (Stephan, 1977).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 211 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 193 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two male rats given 200 mg/kg and all males given 300 mg/kg died on test day 1 or 2. One female given 100 mg/kg and three females given 200 mg/kg died on test day 1.
- Clinical signs:
- other: Clinical observations in rats that died were consistent with their moribund condition. Three males and two females given 200 mg/kg, all females given 150 mg/kg, and all males and four females given 100 mg/kg survived the two-week observation period. Cli
- Gross pathology:
- Male rats given 200 or 300 mg/kg and females given 100 or 200 mg/kg that died had treatment-related gross findings consisting of various combinations of: dark glandular mucosa of the stomach, dilatation of the stomach with cloudy fluid, perineal soiling, and hemolyzed blood in the gastrointestinal tract. Dark foci in the lungs were also noted in two males given 300 mg/kg that died. Surviving animals from all dose groups had no treatment-related gross pathologic observations.
Any other information on results incl. tables
Table 1. Mortality
Dose |
Number of dead / |
Time of death (range) |
100 |
0/5 males |
- |
150 |
0/5 females |
- |
200 |
2/5 males |
day 1 |
300 |
5/5 males |
day 1 (4x), day 2 (1x) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of Bronopol in Fischer 344 rats was approximately 211 mg/kg in males and approximately 193 mg/kg in females.
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