Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The whole report summarizes the data of three mutagenic testing approaches, which were conducted in 1974, prior to the implementation of guidelines. Furthermore, no data referring to purity and stability of the tested substance were provided. However, the results obtained can be considered as scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
- Principles of method if other than guideline:
- Method: other: according to the method of Bateman AJ (Heredity 12: 213-232, 1958) and Bateman AJ and Epstein SS (in Chemical Mutagens, Vol. 2, ed. Hollaender, Plenum Press, 1971)
- GLP compliance:
- no
- Type of assay:
- rodent dominant lethal assay
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:
- not specified
- Details on test material:
- No further data.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: OLAC
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Animals: OLIC ex-breeding stock males of proven fertility. OLIC virgin females, 12 weeks old when mated.
Temperature range 22-24 °C; daylight supplemented by fluorescent tubes on a controlled li.ght/dark cycle, 16 hours on/8 hours off.
Diet: Oxoid cubes and water ad libitum.
Four hours after completion of the dosing, each male was housed with 3 females for mating, which were replaced at weekly intervals for 4 weeks.
Administration / exposure
- Route of administration:
- other: gavage and i.p., respectively
- Details on exposure:
- Application volume: 0.1 ml/10 g bw
- Duration of treatment / exposure:
- Oral dosage: once daily for 6 consecutive days.
Intraperitoneal dosage: single i.p. injection - Frequency of treatment:
- Substance: once daily
Positive control: once (last day of substance dosing) - Post exposure period:
- 4 hours (i.e. 4 hours after the last dosing, the males were housed together with the females for mating.)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 mg/kg bw/day (actual dose received)
- Remarks:
- oral application
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Remarks:
- oral application
- Dose / conc.:
- 10 mg/kg bw (total dose)
- Remarks:
- intraperitoneal application, (0.9% saline)
- No. of animals per sex per dose:
- 10 for test group and positive control
20 for negative control - Control animals:
- other: Twenty 20 males served as negative control. They were treated orally with water.
- Positive control(s):
- Ten males mice were used for positive control.
Positive controls received a single i.p. injection of 25mg/kg bw tris(2-methyl-1-aziridinyl)-phosphine oxide (METEPA) in 0.1 ml/10 g bw of 0.9% physiological saline.
Examinations
- Tissues and cell types examined:
- The females were killed 14 days from the midpoint of the mating week, corresponding to gestation days 9 to 16. Numbers of pregnancies, and live and dead implants were recorded.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Positive controls validity:
- valid
- Additional information on results:
- Summary of the main findings:
Oral treatment with 100 and 20 mg/kg bw bronopol:
Four of the 10 males treated with 100 mg/kg bw bronopol died within 2 weeks (Table 1). The implantation rate was significantly reduced in weeks 2 and 3; this effect was further accompanied by a reduction in fertility as indicated by a decreased pregnancy rate observed in this group (Table 2, 3). No such effects were seen at 20 mg/kg bw. Moreover, for both test doses, no increase in the frequency of dead implants were seen. In fact, for 100 mg/kg bw, the number of dead implants/pregnant female ranged was 0.5, 0.4, 0.2 and 0.5 respectively after 1, 2, 3 and 4 weeks; the corresponding control values respectivley were 0.6, 0.5, 1.0 and 0.7. For 20 mg/kg bw, the values also were within control range.
Injection (i.p.) of 10 mg/kg bw bronopol:
One male from the group receiving 10 mg/kg i.p. died during the third week (Table 1). The implantation rate was significantly reduced in week 4; this effect was further accompanied by a reduction in fertility as indicated by a decreased pregnancy rate observed in this group (Table 2, 3). In this group, a decrease in the frequency of dead implants was seen after 4 weeks (0.2 dead implant per pregnant female versus 0.7 for control).
Positive control (METEPA, 25 mg/kg bw, i.p. injection):
In this group, the number of dead implants per pregnant female was significantly increased compared to untreated control. Mean values of 3.5, 3.9 and 3.1 were reported respectively after week 1, 2 and 3, versus 0.6, 0.5 and 1.0 for controls.
For the highest orally applied dose of bronopol (i.e. 100 mg/kg bw, 6 times) and for the single i.p. injection, a conspicuous decrease in pregnancy rate was observed, which was indicative of a reduced fertility related again to the toxicity of the tested doses of bronopol observed for the males in these groups (Table 2).
Any other information on results incl. tables
Table 1: Cumulative mortalities of Bronopol-treated animals.
Dose |
Cumulative deaths per week (W) |
|||
W1 |
W2 |
W3 |
W4 |
|
0 mg/kg bw (negative control; oral) |
0 |
0 |
0 |
0 |
Bronopol, 6 x 100 mg/kg bw(oral) |
1 |
4 |
4 |
4 |
Bronopol, 6 x 20 mg/kg bw(oral) |
0 |
0 |
0 |
0 |
Bronopol, 1 x 10 mg/kg bw(i.p.) |
0 |
0 |
1 |
1 |
Positive control (METEPA 1x 25 mg/kg bw (i.p.) |
0 |
0 |
0 |
0 |
Table 2: Number of pregnant females per week (per cent).
Dose |
Pregnant females per week (W) |
|||
W1 |
W2 |
W3 |
W4 |
|
0 mg/kg bw (negative control; oral) |
42 (70%) |
34 (57%) |
33 (55%) |
34 (56%) |
Bronopol, 6 x 100 mg/kg bw(oral) |
8 (44%) |
7 (39%) |
9 (50%) |
10 (56%) |
Bronopol, 6 x 20 mg/kg bw(oral) |
20 (67%) |
22 (73%) |
24 (80%) |
23 (76%) |
Bronopol, 1 x 10 mg/kg bw(i.p.) |
9 (33%) |
13 (45%) |
14 (48%) |
12 (44%) |
Positive control (METEPA 1x 25 mg/kg bw (i.p.) |
24 (83%) |
20 (67%) |
21 (70%) |
17 (56%) |
Table 3: Implants per pregnant female (live, dead, total).
Dose |
Live implants per pregnant female and week (W) |
|||
W1 |
W2 |
W3 |
W4 |
|
0 mg/kg bw (negative control; oral) |
9.4 |
9.6 |
9.4 |
10.4 |
Bronopol, 6 x 100 mg/kg bw(oral) |
8.5 |
6.7 |
6.0* |
9.6 |
Bronopol, 6 x 20 mg/kg bw(oral) |
9.8 |
8.4 |
9.3 |
10.6 |
Bronopol, 1 x 10 mg/kg bw(i.p.) |
9.2 |
8.1 |
9.9 |
8.7* |
Positive control (METEPA 1x 25 mg/kg bw (i.p.) |
7.4*** |
4.2*** |
6.9** |
8.7* |
Dose |
Dead implants per pregnant female and week (W) |
|||
W1 |
W2 |
W3 |
W4 |
|
0 mg/kg bw (negative control; oral) |
0.6 |
0.5 |
1.0 |
0.7 |
Bronopol, 6 x 100 mg/kg bw(oral) |
0.5 |
0.4 |
0.2 |
0.5 |
Bronopol, 6 x 20 mg/kg bw(oral) |
1.0 |
0.9 |
0.5 |
0.7 |
Bronopol, 1 x 10 mg/kg bw(i.p.) |
0.7 |
1.2 |
0.3 |
0.2* |
Positive control (METEPA 1x 25 mg/kg bw (i.p.) |
3.5*** |
3.9*** |
3.1*** |
1.2 |
Dose |
Total Number of implants per female and week (W) |
|||
W1 |
W2 |
W3 |
W4 |
|
0 mg/kg bw (negative control; oral) |
10.0 |
10.1 |
10.4 |
11.1 |
Bronopol, 6 x 100 mg/kg bw(oral) |
9.0 |
7.1* |
6.2* |
10.1 |
Bronopol, 6 x 20 mg/kg bw(oral) |
10.8 |
9.3 |
9.8 |
11.2 |
Bronopol, 1 x 10 mg/kg bw(i.p.) |
9.9 |
9.3 |
10.2 |
8.9* |
Positive control (METEPA 1x 25 mg/kg bw (i.p.) |
10.9 |
8.1* |
10.0 |
9.9 |
*, p=<0.05; **, p=<0.01; ***, p=<0.001
Applicant's summary and conclusion
- Conclusions:
- CL-Freetext:
Overt signs of toxicity were seen after 6 daily oral doses
of 100 mg/kg Bronopol in male mice, but not after 6 daily oral doses of 20 mg/kg, nor after a single i.p. injection of 10 mg/kg. Reduced fertility was seen in the high dose group, but not in the others. This effect was considered to be related to toxicity rather than dominant lethality. No increase in dead implants was observed after Bronopol treatment. From these results it was concluded that Bronopol lacks cytotoxicity for mouse meiotic and post-meiotic sperm stages.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.