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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline was mentioned and the study did not follow GLP. The purity of the unlabelled bronopol was not specified. However the data are scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- Method: other: no data
- GLP compliance:
- 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
- Details on test material:
- Bronopol, batch No: 62187, no purity specified
[14C] Bronopol, batch No: 3/A/CM, radiochemical purity > 98%, 14C located on C2
Specific activity of [14C] bronopol: 21 µCi/mg
Specific activity of [14C] bronopol after dilution: 13.4 µCi/mg
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C (located on C2)
Test animals
- Species:
- mouse
- Strain:
- other: CFLP
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Mice were obtained from Interfauna UK Ltd.
Age/weight at study initiation: The mice were approximatively 28 days old and weighed between 17 and 32 g
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- other: acetone:water (9:1)
- Duration and frequency of treatment / exposure:
- Frequency: Three times per week over a period of 30 days (13 applications).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Males: 0.3 ml of 0.5% w/v solution
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Details on study design:
- The mice obtained from Interfauna UK Ltd were allocated into groups of 4 animals each. Prior to the initial treatment, the dorsal skin of each mouse was closely shaved; this was repeated once weekly throughout the test period.The mice received repeated applications of 0.3 ml/mouse of 5 mg/ml adiolabelled bronopol (0.5% w/v test solution in 90% acetone/10% water), over a period of 30 days. The test solution was applied onto the shaved dorsum of each mouse by means of an automatic pipetting device on three days a week (i.e. Monday, Wednesday and Friday), resulting in a total of 13 applications.
- Details on dosing and sampling:
- Blood samples were collected from the mice following sacrifice; for details on sacrifice time point and sampling. Plasma was separated from whole blood by centrifugation, and aliquots were subjected to liquid scintillation in Optiphase Safe liquid scintillator in duplicate (LC).Pooled plasma samples were extracted and the organic phases were pooled and evapored to dryness under nitrogen at 40 °C. Following redissolution , 20 µl aliquots of the extracts were spotted onto thin layer chromatography plates (TLC); [14C] bronopol was used as marker. Development was conducted in chloroform/methanol (4:1). Areas of radioactivity were visualised by autoradiography, scraped at the amounts of radioactivity-related material for each area was measured by LC.Duplicate aliquots of dose material were retained prior and after each dosing period for verification of test substance contents.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The results indicated that [14C] bronopol was absorbed following application to the shaved dorsal skin of mice. Radioactivity was rapidly cleared from plasma after dosing with an apparent t1/2 of ca. 8 hrs, resulting in no accumulation potential at the dose regimen used (see table 1). The plasma profiles for day 1 and day 29 were similar. The observed maximum plasma levels of radioactivity were therefore not affected by an interval of 48 or 72 hours between consecutive dosing.
Toxicokinetic parameters
- Toxicokinetic parameters:
- half-life 1st: ca. 8 h
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- Thin layer chromatography revealed some radioactive material that could be associated to standard [14C] bronopol; the percentage of material however ranged from very low to not detectable. Further compounds that had resulted from the rapid and extensive metabolism of bronopol also were reported. These compounds were no further identified.
Any other information on results incl. tables
Table 1: Concentration of radioactivity in the plasma of mice (µg/ml bronopol equivalent +/- SEM) after repeated dermal applications of bronopol.
Day of Dosing |
Doses (Number) |
Time after dosing (hours) |
|||||
0.5 h |
1 h |
3 h |
6 h |
8 h |
24 h |
||
1 |
1 |
9.1+/-2.2 |
13.0+/-1.8 |
8.2+/-1.0 |
5.5+/-0.5 |
3.7+/-0.2 |
1.5+/-0.1 |
3 |
2 |
11.4+/-1.3 |
1.4+/-0.1 |
||||
5 |
3 |
8.1+/-0.6 |
0.8+/-0.1 |
||||
8* |
4 |
9.7+/-0.3 |
1.3+/-0.2 |
||||
10 |
5 |
16.2+/-1.7 |
1.6+/-0.2 |
||||
12 |
6 |
12.9+/-1.9 |
1.8+/-0.3 |
||||
15* |
7 |
12.8+/-1.3 |
1.2+/-0.1 |
||||
17 |
8 |
11.6+/-1.5 |
1.6+/-0.1 |
||||
19 |
9 |
17.0+/-2.0 |
1.3+/-0.2 |
||||
22* |
10 |
12.9+/-1.6 |
1.5+/-0.2 |
||||
24 |
11 |
13.7+/-1.9 |
1.5+/-0.1 |
||||
26 |
12 |
10.7+/-0.4 |
1.9+/-0.1 |
||||
29* |
13 |
6.7+/-1.8 |
10.7+/-1.0 |
6.7+/-0.7 |
2.2+/-0.5 |
2.2+/-0.2 |
1.4+/-0.1 |
*, indicated 3 day gap since previous dosing
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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